Privacy Act of 1974, New OIG Privacy Act System of Records: Litigation Files, 20311-20314 [E8-7987]
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Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Notices
and 316.21. These requirements
include, but are not limited to,
documentation of the following:
• The disease or condition for which
the drug is intended affects fewer than
200,000 people in the United States
(e.g., tuberculosis, malaria,
trypanosomiasis).
• If the drug is a vaccine, diagnostic
drug, or preventative drug, the persons
to whom the drug will be administered
in the United States are fewer than
200,000 per year.
• For a drug intended for diseases or
conditions affecting 200,000 or more
people, or for a vaccine, diagnostic drug,
or preventative drug to be administered
to 200,000 or more persons per year in
the United States, there is no reasonable
expectation that costs of research and
development of the drug for the
indication can be recovered by sales of
the drug in the United States.
Antimicrobial drugs that have
qualified for orphan drug designation in
the past include some indicated for the
treatment of tuberculosis, malaria, and
trypanosomiasis.
II. Purpose and Scope of the Hearing
This hearing is intended to provide
the infectious disease community,
sponsors, and other interested parties an
opportunity to discuss their experience
with and concerns about the emerging
threat of antimicrobial resistance,
possible strategies fostering prudent use
to prevent the development of
antimicrobial resistance, and the
potential for the provisions of the
Orphan Drug Act or other incentives to
facilitate antimicrobial drug
development, including what, if any,
conditions might be required to
accompany such incentives.
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III. Issues for Discussion
FDA invites comments from
interested parties on the following
questions:
1. Please discuss strategies that
should be considered to limit the
development of antimicrobial
resistance, and studies that could be
done to assess the utility, safety and
effectiveness of those strategies. Possible
examples include limiting the approved
conditions of use, limiting the duration
of therapy, restricting distribution to
encourage appropriate use, using shorter
courses of therapy with higher doses of
antimicrobials, and using directly
observed therapy.
2. Please discuss the possible utility
and effectiveness of economic
incentives in promoting drug
development for antimicrobial resistant
organisms.
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a. What is the potential role of the
Orphan Drug Act in providing
incentives to facilitate antimicrobial
drug development? Please describe the
serious and life-threatening infectious
diseases for which the Orphan Drug Act
provides viable research and
development incentives. Please
comment on the potential complexities
associated with identifying appropriate
orphan populations in the infectious
disease context.
b. Are there specific incentives (other
than those provided by the Orphan Drug
Act) that could facilitate the
development of new antimicrobial
therapies for serious and life-threatening
diseases? Describe those serious and
life-threatening infectious diseases, such
as diseases due to gram-negative
bacteria and other diseases due to
antimicrobial-resistant bacteria, which
could be considered under an
alternative incentive program.
written or electronic comments to the
Division of Dockets Management (see
ADDRESSES). Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments should be identified
with the docket number found in
brackets in the heading of this
document. To ensure consideration,
submit comments by (see DATES).
Received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner is announcing that
the public hearing will be held in
accordance with part 15 (21 CFR part
15). The hearing will be conducted by
a presiding officer, accompanied by
FDA senior management from the Office
of the Commissioner, the Center for
Drug Evaluation and Research, the
Center for Biologics Evaluation and
Research, and FDA’s Office of Orphan
Drugs.
Under § 15.30(f), the hearing is
informal, and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation.
Public hearings under part 15 are
subject to FDA’s policy and procedures
for electronic media coverage of FDA’s
public administrative proceedings (part
10 (21 CFR part 10), subpart C)). Under
§ 10.205, representatives of the
electronic media may be permitted,
subject to certain limitations, to
videotape, film, or otherwise record
FDA’s public administrative
proceedings, including presentations by
participants. The hearing will be
transcribed as stipulated in § 15.30(b).
To the extent that the conditions for
the hearing, as described in this notice,
conflict with any provisions set out in
part 15, this notice acts as a waiver of
those provisions as specified in 21 CFR
15.30(h).
VI. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm. It may be
viewed at the Division of Dockets
Management (see ADDRESSES). A
transcript will also be available in either
hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
(HFI–35), Office of Management
Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
V. Request for Comments
Regardless of attendance at the public
hearing, interested persons may submit
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Dated: April 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. 08–1129 Filed 4–10–08; 12:23 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Privacy Act of 1974, New OIG Privacy
Act System of Records: Litigation Files
Office of Inspector General
(OIG), HHS.
ACTION: Notice of proposed new Privacy
Act systems of records.
AGENCY:
SUMMARY: The Office of Inspector
General (OIG) is proposing a new
system of records, entitled Litigation
Files, Administrative Complaints, and
Personnel Actions, HHS/OS/OIG/OCIG
(09–90–0077). This proposed notice is
in accordance with the Privacy Act
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requirement that agencies publish their
systems of records in the Federal
Register when there is a revision,
change, or addition. This new system
will replicate the existing system of
records, entitled Litigation Files,
Administrative Complaints, and
Adverse Personnel Actions, HHS/OS/
OGC (09–90–0064), to reflect that
responsibility for providing legal
services to the Inspector General has
transferred to OIG’s Office of Counsel to
the Inspector General (OCIG). The
existing Litigation Files system of
records (09–90–0064) remains with the
Department’s Office of General Counsel
and will be unchanged. This notice
specifically covers that portion of the
records that transferred to, or have been
since created and maintained by, OCIG.
The Litigation Files, Administrative
Complaints, and Personnel Actions,
HHS/OS/OIG/OCIG system of records
will be maintained for the purposes of
representing OIG and its components in
court cases and administrative
proceedings, in accordance with the
Inspector General Act of 1978 (5 U.S.C.
App.).
DATES: Effective Date: This system of
records will become effective without
further notice on June 16, 2008, unless
comments received on or before that
date result in a contrary determination.
Comment Date: Comments on this
new system of records will be
considered if we receive them at the
addresses provided below no later than
5 p.m. Eastern Standard Time on May
15, 2008.
ADDRESSES: In commenting, please
reference file code OIG–796–PN.
Because of staff and resource
limitations, we cannot accept comments
by facsimile (Fax) transmission.
However, you may submit comments
using one of the following three ways
(no duplicates, please):
1. Electronically. You may submit
electronically through the Federal
eRulemaking Portal at https://
www.regulations.gov. (Attachments
should be in Microsoft Word, if
possible.)
2. By regular, express, or overnight
mail. You may mail your printed or
written submissions to the following
address: Office of Inspector General,
Department of Health and Human
Services, Attention: OIG–796–PN, Room
5246, Cohen Building, 330
Independence Avenue, SW.,
Washington, DC 20201. Please allow
sufficient time for mailed comments to
be received before the close of the
comment period.
3. By hand or courier. You may
deliver, by hand or courier, before the
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close of the comment period, your
printed or written comments to the
Office of Inspector General, Department
of Health and Human Services, Cohen
Building, 330 Independence Avenue,
SW., Washington, DC 20201. Because
access to the interior of the Cohen
Building is not readily available to
persons without Federal Government
identification, commenters are
encouraged to schedule their delivery
with one of our staff members at (202)
358–3141. Inspection of Public
Comments: All comments received
before the end of the comment period
will be posted on https://
www.regulations.gov for public viewing.
Hard copies will also be available for
public inspection at the Office of
Inspector General, Department of Health
and Human Services, Cohen Building,
330 Independence Avenue, SW.,
Washington, DC 20201, Monday
through Friday from 8:30 a.m. to 4 p.m.
To schedule an appointment to view
public comments, phone (202) 619–
0089.
FOR FURTHER INFORMATION CONTACT:
Melissa McCurdy, Office of Counsel to
the Inspector General, (202) 619–0335.
SUPPLEMENTARY INFORMATION: The Office
of Inspector General (OIG) proposes to
establish a new Privacy Act system of
records, 09–90–0077, Litigation Files,
Administrative Complaints, and
Personnel Actions, HHS/OS/OIG/OCIG.
The new system will duplicate an
existing Privacy Act system of
Records—Litigation Files,
Administrative Complaints, and
Adverse Personnel Actions HHS/OS/
OGC (09–90–0064)—which was last
revised and updated in the Federal
Register on November 9, 1994 (59 FR
55845), by adding a new routine use to
permit the disclosure of information
from this system to certain individuals
working in various offices within the
Office of the Secretary, but who do not
have the status of agency employees
and, in many instances, do not receive
pay for their work.
The new system of records—
Litigation Files, Administrative
Complaints, and Personnel Actions,
HHS/OS/OIG/OCIG (09–90–0077)—will
replicate the 09–90–0064 system of
records, but will modify the ‘‘System
Name,’’ ‘‘System Location,’’ ‘‘Categories
of Individuals Covered by the System,’’
‘‘Authority for Maintenance of the
System,’’ ‘‘Routine Uses,’’ ‘‘Purposes,’’
‘‘System Safeguards,’’ and ‘‘System
Manager(s) and Address’’ sections.
Records in the system have been located
and maintained in OIG’s headquarters.
The modification of the ‘‘System
Name,’’ ‘‘System Location,’’ ‘‘Authority
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for Maintenance of the System,’’
‘‘Routine Uses,’’ ‘‘Purposes,’’ ‘‘Storage,’’
‘‘System Safeguards,’’ and ‘‘System
Manager(s) and Address’’ sections are to
reflect that responsibility for providing
legal services to the Inspector General
transferred to the Office of Counsel to
the Inspector General (OCIG).
The Inspector General Act of 1978
established OIG ‘‘to conduct and
supervise audits and investigations
relating to the programs and operations’’
of the Department of Health and Human
Services (HHS). Within OIG, OCIG (1)
provides general legal services to OIG
including, among other things, advice
and representation on HHS programs
and operations, administrative law
issues, and criminal procedure; (2)
imposes program exclusions and civil
money penalties on health care
providers and litigates those actions
within the Department; (3) represents
OIG in the global settlement of cases
arising under the False Claims Act; and
(4) represents OIG in personnel actions.
Description of the Proposed System of
Records
The Litigation Files, Administrative
Complaints, and Personnel Actions,
HHS/OS/OIG/OCIG system will enable
OCIG to access and maintain records for
the purpose of representing OIG and its
components in court cases and
administrative proceedings. The system
will house records pertaining to
litigation, administrative complaints,
and personnel actions in which OIG is,
or was, involved.
Agency Policies, Procedures, and
Restrictions on the Routine Use
The Privacy Act permits OIG to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purposes for which
the information was collected. Any such
disclosure of data is known as a routine
use. We are proposing to establish the
following routine use disclosures of
records maintained in the system:
1. 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 request of that individual.
2. In the event of litigation,
information from the system of records
may be disclosed to the Department of
Justice, to a judicial or administrative
tribunal, opposing counsel, and
witnesses, in the course of proceedings
involving HHS, any HHS employee
(where the matter pertains to the
employee’s official duties), or the
United States, or any agency thereof
where the litigation is likely to affect
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HHS, or HHS is a party or has an
interest in the litigation and the use of
the information is relevant and
necessary to the litigation.
3. In the event that a system of records
maintained by this agency to carry out
its functions indicates a violation or
potential violation of law, whether civil,
criminal or regulatory in nature, and
whether arising by general statute or
particular program statute, or by
regulation, rule or order issued pursuant
thereto, the relevant records in the
system of records may be referred, as a
routine use, to the appropriate agency,
whether Federal, or foreign, charged
with the responsibility of investigating
or prosecuting such violation or charged
with enforcing or implementing the
statute or rule, regulation, or order
issued pursuant thereto.
4. In the event the Department deems
it desirable or necessary, in determining
whether particular records are required
to be disclosed under the Freedom of
Information Act, disclosure may be
made to the Department of Justice for
the purpose of obtaining its advice.
5. A record from this system of
records may be disclosed as a ‘‘routine
use’’ to a Federal, State, or local agency
maintaining civil, criminal, or other
relevant enforcement records or other
pertinent records, such as current
licenses, if necessary to obtain a record
relevant to an agency decision
concerning the hiring or retention of an
employee, the issuance of a security
clearance, the letting of a contract, or
the issuance of a license, grant, or other
benefit.
6. A record from this system of
records may be disclosed to a Federal
agency in response to its request, in
connection with the hiring or retention
of an employee, the issuance of a
security clearance, the reporting of an
investigation of an employee, the letting
of a contract, or the issuance of a
license, grant, or other benefit by the
requesting agency, to the extent that the
record is relevant and necessary to the
requesting agency’s decision on the
matter.
7. Information in this system of
records may be disclosed to a Federal,
State, or local agency maintaining civil,
criminal, or other relevant enforcement
records, or other pertinent records, such
as current licenses, if necessary to
obtain a record relevant to an agency
concerning the hiring or retention of an
employee, the issuance of a license,
grant, or other benefit.
8. To student volunteers and other
individuals performing functions for the
Department, but technically not having
the status of agency employees, if they
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need access to the records in order to
perform their assigned agency functions.
9. A record may be disclosed to
appropriate Federal agencies and
Department contractors that have a need
to know the information for the purpose
of assisting the Department’s efforts to
respond to a suspected or confirmed
breach of the security or confidentiality
of information maintained in this
system of records, and the information
disclosed is relevant and necessary for
that assistance.
Safeguards
OIG has safeguards in place for
authorized users and monitors users to
ensure against unauthorized use. The
system will conform to all applicable
Federal laws and regulations and
Federal, HHS, and OIG policies and
standards as they relate to information
security and data privacy.
Effects of the Proposed System of
Records on Individual Rights
This system is established in
accordance with the principles and
requirements of the Privacy Act and will
collect, use, and disseminate
information only as prescribed therein.
Data in this system will be subject to the
authorized releases in accordance with
the routine uses identified in this
system of records notice.
OIG will take precautionary measures
to minimize the risks of unauthorized
access to the records and the potential
harm to individual privacy or other
personal or property rights of applicants
whose data are maintained in the
system. OCIG will make disclosures
from the proposed system in accordance
with the Privacy Act. OCIG does not
anticipate an unfavorable effect on
individual privacy as a result of the
disclosure of information relating to
individuals.
This proposed change will not
otherwise increase access to these
records.
Dated: April 10, 2008.
Daniel R. Levinson,
Inspector General.
09–90–0077
SYSTEM NAME:
Litigation Files, Administrative
Complaints, and Personnel Actions, HS/
OS/OIG/OCIG.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Office of Counsel to the Inspector
General (OCIG), Department of Health
and Human Services, Room 5527,
PO 00000
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20313
Wilbur J. Cohen Building, 330
Independence Avenue, SW.,
Washington, DC 20201.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The individuals on whom records are
maintained in this system are
individuals who are involved in civil,
criminal, or administrative litigation
with the Department or the United
States (regarding matters within the
jurisdiction of the Department) either as
plaintiffs or as defendants, and
individuals who either file
administrative complaints with the
Department or are the subjects of
administrative complaints initiated by
the Department.
CATEGORIES OF RECORDS IN THE SYSTEM:
These records contain information
pertaining to the subject matter of the
litigation, administrative complaint, or
personnel action. Such records would
include complaints, litigation reports,
administrative transcripts, various
litigation documents, investigative
materials, correspondence, briefs, court
orders, and judgments.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The authority for maintaining this
system is found in the various statutes,
regulations, rules, or orders pertaining
to the subject matter of the litigation,
administrative complaint, or adverse
personnel action, (e.g., Inspector
General Act and the Social Security
Act).
PURPOSE(S):
To advise and represent the Office of
Inspector General and its components in
court cases and administrative
proceedings.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:
a. 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 request of that individual.
b. In the event of litigation,
information from the system of records
may be disclosed to the Department of
Justice, to a judicial or administrative
tribunal, opposing counsel, and
witnesses, in the course of proceedings
involving HHS, any HHS employee
(where the matter pertains to the
employee’s official duties), or the
United States, or any agency thereof
where the litigation is likely to affect
HHS, or HHS is a party or has an
interest in the litigation and the use of
the information is relevant and
necessary to the litigation.
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c. In the event that a system of records
maintained by this agency to carry out
its functions indicates a violation or
potential violation of law, whether civil,
criminal, or regulatory in nature, and
whether arising by general statute or
particular program statute, or by
regulation, rule, or order issued
pursuant thereto, the relevant records in
the system of records may be referred,
as a routine use, to the appropriate
agency, whether Federal or foreign,
charged with the responsibility of
investigating or prosecuting such
violation or charged with enforcing or
implementing the statute or rule,
regulation or order issued pursuant
thereto.
d. In the event the Department deems
it desirable or necessary, in determining
whether particular records are required
to be disclosed under the Freedom of
Information Act, disclosure may be
made to the Department of Justice for
the purpose of obtaining its advice.
e. A record from this system of
records may be disclosed as a ‘‘routine
use’’ to a Federal, State, or local agency
maintaining civil, criminal, or other
relevant enforcement records or other
pertinent records, such as current
licenses, if necessary to obtain a record
relevant to an agency decision
concerning the hiring or retention of an
employee, the issuance of a security
clearance, the letting of a contract, or
the issuance of a license, grant, or other
benefit.
f. A record from this system of records
may be disclosed to a Federal agency,
response to its request, in connection
with the hiring or retention of an
employee, the issuance of a security
clearance, the reporting of an
investigation of an employee, the letting
of a contract, or the issuance of a
license, grant, or other benefit by the
requesting agency, to the extent that the
record is relevant and necessary to the
requesting agency’s decision on the
matter.
g. Information in this system of
records may be disclosed to a Federal,
State, or local agency maintaining civil,
criminal, or other relevant enforcement
records, or other pertinent records, such
as current licenses, if necessary to
obtain a record relevant to an agency
concerning the hiring or retention of an
employee, the issuance of a license,
grant, or other benefit.
h. To student volunteers and other
individuals performing functions for the
Department, but technically not having
the status of agency employees, if they
need access to the records in order to
perform their assigned agency functions.
i. A record may be disclosed to
appropriate Federal agencies and
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Department contractors that have a need
to know the information for the purpose
of assisting the Department’s efforts to
respond to a suspected or confirmed
breach of the security or confidentiality
of information maintained in this
system of records, and the information
disclosed is relevant and necessary for
that assistance.
RECORDS ACCESS PROCEDURES:
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
Contact the official at the address
System Manager(s) and Address above,
and reasonably identify the record and
specify the information to be contested
and corrective action sought with
supporting justification. (These
procedures are in accordance with
Department regulations (45 CFR 5b.7).)
STORAGE:
Records are stored in electronic form
and paper files are stored in locked file
cabinets.
Same as notification procedures.
Requesters should also reasonably
specify the record contents being
sought. (These access procedures are in
accordance with Department regulations
(45 CFR 5b.5 (a)(2).)
CONTESTING RECORD PROCEDURES:
RETRIEVABILITY:
These records are retrievable by name
of the plaintiff or the first plaintiff if
there is more than one, or by the name
of the first defendant if the plaintiff is
the United States. In the case of
personnel actions, records are
retrievable by name of the individual
involved.
SAFEGUARDS:
Office buildings in which these
records are maintained are secured by a
variety of security systems. The
computer terminals used to access the
records are secured with passwords,
encryptions, and other security devices,
comply with all relevant computer
security procedures, and are kept in
rooms that are locked at the close of the
business day, and are generally
accessible only to OCIG staff.
RETENTION AND DISPOSAL:
These records are maintained for an
indefinite duration.
SYSTEM MANAGER(S) AND ADDRESS:
The agency official responsible for the
system policies and practices outlined
above is: The Chief Counsel, Office of
Counsel to the Inspector General,
Department of Health and Human
Services, Wilbur J. Cohen Building,
Room 5527, 330 Independence Avenue,
SW., Washington, DC 20201.
NOTIFICATION PROCEDURES:
Any inquiries regarding these systems
of records should be addressed to the
System Manager. An individual who
requests notification of or access to a
medical record shall, at the time the
request is made, designate in writing a
responsible representative who will be
willing to review the record and inform
the subject individual of its contents at
the representative’s discretion. (These
notification and access procedures are
in accordance with Department
regulations (45 CFR 5b.6).)
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RECORD SOURCE CATEGORIES:
The information for this system is
obtained through a number of sources
including the exchange of legal
pleadings, documents, formal and
informal discovery, program offices and
component agencies, private attorneys,
State and local governments, their
agencies and instrumentalities, and
officers of other Federal agencies and
the individuals involved.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E8–7987 Filed 4–14–08; 8:45 am]
BILLING CODE 4152–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Call for Nominations for the
National Cancer Institute Director’s
Consumer Liaison Group
Notice is hereby given of a change in
the Call for Nominations for the
National Cancer Institute Director’s
Consumer Liaison Group which was
published in the Federal Register on
March 18, 2008, 73 FR 14476–14477.
This call for nominations is being
amended to revise the due date for
candidates interested in being
considered for appointment to the
Director’s Consumer Liaison Group to
postmark their nomination package by
April 30, 2008 instead of April 15, 2008.
Dated: April 8, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–7929 Filed 4–14–08; 8:45 am]
BILLING CODE 4140–01–M
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Agencies
[Federal Register Volume 73, Number 73 (Tuesday, April 15, 2008)]
[Notices]
[Pages 20311-20314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7987]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
Privacy Act of 1974, New OIG Privacy Act System of Records:
Litigation Files
AGENCY: Office of Inspector General (OIG), HHS.
ACTION: Notice of proposed new Privacy Act systems of records.
-----------------------------------------------------------------------
SUMMARY: The Office of Inspector General (OIG) is proposing a new
system of records, entitled Litigation Files, Administrative
Complaints, and Personnel Actions, HHS/OS/OIG/OCIG (09-90-0077). This
proposed notice is in accordance with the Privacy Act
[[Page 20312]]
requirement that agencies publish their systems of records in the
Federal Register when there is a revision, change, or addition. This
new system will replicate the existing system of records, entitled
Litigation Files, Administrative Complaints, and Adverse Personnel
Actions, HHS/OS/OGC (09-90-0064), to reflect that responsibility for
providing legal services to the Inspector General has transferred to
OIG's Office of Counsel to the Inspector General (OCIG). The existing
Litigation Files system of records (09-90-0064) remains with the
Department's Office of General Counsel and will be unchanged. This
notice specifically covers that portion of the records that transferred
to, or have been since created and maintained by, OCIG. The Litigation
Files, Administrative Complaints, and Personnel Actions, HHS/OS/OIG/
OCIG system of records will be maintained for the purposes of
representing OIG and its components in court cases and administrative
proceedings, in accordance with the Inspector General Act of 1978 (5
U.S.C. App.).
DATES: Effective Date: This system of records will become effective
without further notice on June 16, 2008, unless comments received on or
before that date result in a contrary determination.
Comment Date: Comments on this new system of records will be
considered if we receive them at the addresses provided below no later
than 5 p.m. Eastern Standard Time on May 15, 2008.
ADDRESSES: In commenting, please reference file code OIG-796-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (Fax) transmission. However, you may submit comments using
one of the following three ways (no duplicates, please):
1. Electronically. You may submit electronically through the
Federal eRulemaking Portal at https://www.regulations.gov. (Attachments
should be in Microsoft Word, if possible.)
2. By regular, express, or overnight mail. You may mail your
printed or written submissions to the following address: Office of
Inspector General, Department of Health and Human Services, Attention:
OIG-796-PN, Room 5246, Cohen Building, 330 Independence Avenue, SW.,
Washington, DC 20201. Please allow sufficient time for mailed comments
to be received before the close of the comment period.
3. By hand or courier. You may deliver, by hand or courier, before
the close of the comment period, your printed or written comments to
the Office of Inspector General, Department of Health and Human
Services, Cohen Building, 330 Independence Avenue, SW., Washington, DC
20201. Because access to the interior of the Cohen Building is not
readily available to persons without Federal Government identification,
commenters are encouraged to schedule their delivery with one of our
staff members at (202) 358-3141. Inspection of Public Comments: All
comments received before the end of the comment period will be posted
on https://www.regulations.gov for public viewing. Hard copies will also
be available for public inspection at the Office of Inspector General,
Department of Health and Human Services, Cohen Building, 330
Independence Avenue, SW., Washington, DC 20201, Monday through Friday
from 8:30 a.m. to 4 p.m. To schedule an appointment to view public
comments, phone (202) 619-0089.
FOR FURTHER INFORMATION CONTACT: Melissa McCurdy, Office of Counsel to
the Inspector General, (202) 619-0335.
SUPPLEMENTARY INFORMATION: The Office of Inspector General (OIG)
proposes to establish a new Privacy Act system of records, 09-90-0077,
Litigation Files, Administrative Complaints, and Personnel Actions,
HHS/OS/OIG/OCIG. The new system will duplicate an existing Privacy Act
system of Records--Litigation Files, Administrative Complaints, and
Adverse Personnel Actions HHS/OS/OGC (09-90-0064)--which was last
revised and updated in the Federal Register on November 9, 1994 (59 FR
55845), by adding a new routine use to permit the disclosure of
information from this system to certain individuals working in various
offices within the Office of the Secretary, but who do not have the
status of agency employees and, in many instances, do not receive pay
for their work.
The new system of records--Litigation Files, Administrative
Complaints, and Personnel Actions, HHS/OS/OIG/OCIG (09-90-0077)--will
replicate the 09-90-0064 system of records, but will modify the
``System Name,'' ``System Location,'' ``Categories of Individuals
Covered by the System,'' ``Authority for Maintenance of the System,''
``Routine Uses,'' ``Purposes,'' ``System Safeguards,'' and ``System
Manager(s) and Address'' sections. Records in the system have been
located and maintained in OIG's headquarters. The modification of the
``System Name,'' ``System Location,'' ``Authority for Maintenance of
the System,'' ``Routine Uses,'' ``Purposes,'' ``Storage,'' ``System
Safeguards,'' and ``System Manager(s) and Address'' sections are to
reflect that responsibility for providing legal services to the
Inspector General transferred to the Office of Counsel to the Inspector
General (OCIG).
The Inspector General Act of 1978 established OIG ``to conduct and
supervise audits and investigations relating to the programs and
operations'' of the Department of Health and Human Services (HHS).
Within OIG, OCIG (1) provides general legal services to OIG including,
among other things, advice and representation on HHS programs and
operations, administrative law issues, and criminal procedure; (2)
imposes program exclusions and civil money penalties on health care
providers and litigates those actions within the Department; (3)
represents OIG in the global settlement of cases arising under the
False Claims Act; and (4) represents OIG in personnel actions.
Description of the Proposed System of Records
The Litigation Files, Administrative Complaints, and Personnel
Actions, HHS/OS/OIG/OCIG system will enable OCIG to access and maintain
records for the purpose of representing OIG and its components in court
cases and administrative proceedings. The system will house records
pertaining to litigation, administrative complaints, and personnel
actions in which OIG is, or was, involved.
Agency Policies, Procedures, and Restrictions on the Routine Use
The Privacy Act permits OIG to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purposes for which the information was
collected. Any such disclosure of data is known as a routine use. We
are proposing to establish the following routine use disclosures of
records maintained in the system:
1. 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 request of that individual.
2. In the event of litigation, information from the system of
records may be disclosed to the Department of Justice, to a judicial or
administrative tribunal, opposing counsel, and witnesses, in the course
of proceedings involving HHS, any HHS employee (where the matter
pertains to the employee's official duties), or the United States, or
any agency thereof where the litigation is likely to affect
[[Page 20313]]
HHS, or HHS is a party or has an interest in the litigation and the use
of the information is relevant and necessary to the litigation.
3. In the event that a system of records maintained by this agency
to carry out its functions indicates a violation or potential violation
of law, whether civil, criminal or regulatory in nature, and whether
arising by general statute or particular program statute, or by
regulation, rule or order issued pursuant thereto, the relevant records
in the system of records may be referred, as a routine use, to the
appropriate agency, whether Federal, or foreign, charged with the
responsibility of investigating or prosecuting such violation or
charged with enforcing or implementing the statute or rule, regulation,
or order issued pursuant thereto.
4. In the event the Department deems it desirable or necessary, in
determining whether particular records are required to be disclosed
under the Freedom of Information Act, disclosure may be made to the
Department of Justice for the purpose of obtaining its advice.
5. A record from this system of records may be disclosed as a
``routine use'' to a Federal, State, or local agency maintaining civil,
criminal, or other relevant enforcement records or other pertinent
records, such as current licenses, if necessary to obtain a record
relevant to an agency decision concerning the hiring or retention of an
employee, the issuance of a security clearance, the letting of a
contract, or the issuance of a license, grant, or other benefit.
6. A record from this system of records may be disclosed to a
Federal agency in response to its request, in connection with the
hiring or retention of an employee, the issuance of a security
clearance, the reporting of an investigation of an employee, the
letting of a contract, or the issuance of a license, grant, or other
benefit by the requesting agency, to the extent that the record is
relevant and necessary to the requesting agency's decision on the
matter.
7. Information in this system of records may be disclosed to a
Federal, State, or local agency maintaining civil, criminal, or other
relevant enforcement records, or other pertinent records, such as
current licenses, if necessary to obtain a record relevant to an agency
concerning the hiring or retention of an employee, the issuance of a
license, grant, or other benefit.
8. To student volunteers and other individuals performing functions
for the Department, but technically not having the status of agency
employees, if they need access to the records in order to perform their
assigned agency functions.
9. A record may be disclosed to appropriate Federal agencies and
Department contractors that have a need to know the information for the
purpose of assisting the Department's efforts to respond to a suspected
or confirmed breach of the security or confidentiality of information
maintained in this system of records, and the information disclosed is
relevant and necessary for that assistance.
Safeguards
OIG has safeguards in place for authorized users and monitors users
to ensure against unauthorized use. The system will conform to all
applicable Federal laws and regulations and Federal, HHS, and OIG
policies and standards as they relate to information security and data
privacy.
Effects of the Proposed System of Records on Individual Rights
This system is established in accordance with the principles and
requirements of the Privacy Act and will collect, use, and disseminate
information only as prescribed therein. Data in this system will be
subject to the authorized releases in accordance with the routine uses
identified in this system of records notice.
OIG will take precautionary measures to minimize the risks of
unauthorized access to the records and the potential harm to individual
privacy or other personal or property rights of applicants whose data
are maintained in the system. OCIG will make disclosures from the
proposed system in accordance with the Privacy Act. OCIG does not
anticipate an unfavorable effect on individual privacy as a result of
the disclosure of information relating to individuals.
This proposed change will not otherwise increase access to these
records.
Dated: April 10, 2008.
Daniel R. Levinson,
Inspector General.
09-90-0077
SYSTEM NAME:
Litigation Files, Administrative Complaints, and Personnel Actions,
HS/OS/OIG/OCIG.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Office of Counsel to the Inspector General (OCIG), Department of
Health and Human Services, Room 5527, Wilbur J. Cohen Building, 330
Independence Avenue, SW., Washington, DC 20201.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The individuals on whom records are maintained in this system are
individuals who are involved in civil, criminal, or administrative
litigation with the Department or the United States (regarding matters
within the jurisdiction of the Department) either as plaintiffs or as
defendants, and individuals who either file administrative complaints
with the Department or are the subjects of administrative complaints
initiated by the Department.
CATEGORIES OF RECORDS IN THE SYSTEM:
These records contain information pertaining to the subject matter
of the litigation, administrative complaint, or personnel action. Such
records would include complaints, litigation reports, administrative
transcripts, various litigation documents, investigative materials,
correspondence, briefs, court orders, and judgments.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The authority for maintaining this system is found in the various
statutes, regulations, rules, or orders pertaining to the subject
matter of the litigation, administrative complaint, or adverse
personnel action, (e.g., Inspector General Act and the Social Security
Act).
PURPOSE(S):
To advise and represent the Office of Inspector General and its
components in court cases and administrative proceedings.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
a. 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 request of that individual.
b. In the event of litigation, information from the system of
records may be disclosed to the Department of Justice, to a judicial or
administrative tribunal, opposing counsel, and witnesses, in the course
of proceedings involving HHS, any HHS employee (where the matter
pertains to the employee's official duties), or the United States, or
any agency thereof where the litigation is likely to affect HHS, or HHS
is a party or has an interest in the litigation and the use of the
information is relevant and necessary to the litigation.
[[Page 20314]]
c. In the event that a system of records maintained by this agency
to carry out its functions indicates a violation or potential violation
of law, whether civil, criminal, or regulatory in nature, and whether
arising by general statute or particular program statute, or by
regulation, rule, or order issued pursuant thereto, the relevant
records in the system of records may be referred, as a routine use, to
the appropriate agency, whether Federal or foreign, charged with the
responsibility of investigating or prosecuting such violation or
charged with enforcing or implementing the statute or rule, regulation
or order issued pursuant thereto.
d. In the event the Department deems it desirable or necessary, in
determining whether particular records are required to be disclosed
under the Freedom of Information Act, disclosure may be made to the
Department of Justice for the purpose of obtaining its advice.
e. A record from this system of records may be disclosed as a
``routine use'' to a Federal, State, or local agency maintaining civil,
criminal, or other relevant enforcement records or other pertinent
records, such as current licenses, if necessary to obtain a record
relevant to an agency decision concerning the hiring or retention of an
employee, the issuance of a security clearance, the letting of a
contract, or the issuance of a license, grant, or other benefit.
f. A record from this system of records may be disclosed to a
Federal agency, response to its request, in connection with the hiring
or retention of an employee, the issuance of a security clearance, the
reporting of an investigation of an employee, the letting of a
contract, or the issuance of a license, grant, or other benefit by the
requesting agency, to the extent that the record is relevant and
necessary to the requesting agency's decision on the matter.
g. Information in this system of records may be disclosed to a
Federal, State, or local agency maintaining civil, criminal, or other
relevant enforcement records, or other pertinent records, such as
current licenses, if necessary to obtain a record relevant to an agency
concerning the hiring or retention of an employee, the issuance of a
license, grant, or other benefit.
h. To student volunteers and other individuals performing functions
for the Department, but technically not having the status of agency
employees, if they need access to the records in order to perform their
assigned agency functions.
i. A record may be disclosed to appropriate Federal agencies and
Department contractors that have a need to know the information for the
purpose of assisting the Department's efforts to respond to a suspected
or confirmed breach of the security or confidentiality of information
maintained in this system of records, and the information disclosed is
relevant and necessary for that assistance.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in electronic form and paper files are stored in
locked file cabinets.
RETRIEVABILITY:
These records are retrievable by name of the plaintiff or the first
plaintiff if there is more than one, or by the name of the first
defendant if the plaintiff is the United States. In the case of
personnel actions, records are retrievable by name of the individual
involved.
SAFEGUARDS:
Office buildings in which these records are maintained are secured
by a variety of security systems. The computer terminals used to access
the records are secured with passwords, encryptions, and other security
devices, comply with all relevant computer security procedures, and are
kept in rooms that are locked at the close of the business day, and are
generally accessible only to OCIG staff.
RETENTION AND DISPOSAL:
These records are maintained for an indefinite duration.
SYSTEM MANAGER(S) AND ADDRESS:
The agency official responsible for the system policies and
practices outlined above is: The Chief Counsel, Office of Counsel to
the Inspector General, Department of Health and Human Services, Wilbur
J. Cohen Building, Room 5527, 330 Independence Avenue, SW., Washington,
DC 20201.
NOTIFICATION PROCEDURES:
Any inquiries regarding these systems of records should be
addressed to the System Manager. An individual who requests
notification of or access to a medical record shall, at the time the
request is made, designate in writing a responsible representative who
will be willing to review the record and inform the subject individual
of its contents at the representative's discretion. (These notification
and access procedures are in accordance with Department regulations (45
CFR 5b.6).)
RECORDS ACCESS PROCEDURES:
Same as notification procedures. Requesters should also reasonably
specify the record contents being sought. (These access procedures are
in accordance with Department regulations (45 CFR 5b.5 (a)(2).)
CONTESTING RECORD PROCEDURES:
Contact the official at the address System Manager(s) and Address
above, and reasonably identify the record and specify the information
to be contested and corrective action sought with supporting
justification. (These procedures are in accordance with Department
regulations (45 CFR 5b.7).)
RECORD SOURCE CATEGORIES:
The information for this system is obtained through a number of
sources including the exchange of legal pleadings, documents, formal
and informal discovery, program offices and component agencies, private
attorneys, State and local governments, their agencies and
instrumentalities, and officers of other Federal agencies and the
individuals involved.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. E8-7987 Filed 4-14-08; 8:45 am]
BILLING CODE 4152-01-P