Office of Research Integrity; Privacy Act of 1974; Report of an Altered System of Records, 44847-44850 [E9-20893]
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Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices
evaluate a petition to designate a class
of employees for the Metals and
Controls Corporation in Attleboro,
Massachusetts, to be included in the
Special Exposure Cohort under the
Energy Employees Occupational Illness
Compensation Program Act of 2000. The
initial proposed definition for the class
being evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Metals and Controls
Corporation.
Location: Attleboro, Massachusetts.
Job Titles and/or Job Duties: All
Atomic Weapons Employer employees
who were exposed to thorium.
Period of Employment: January 1,
1952 through December 31, 1967.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
Christine M. Branche,
Acting Director, National Institute for
Occupational Safety and Health.
[FR Doc. E9–20899 Filed 8–28–09; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Research Integrity; Privacy
Act of 1974; Report of an Altered
System of Records
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AGENCY: Office of Research Integrity
(ORI), Office of Public Health and
Science (OPHS), Office of the Secretary
(OS), Department of Health and Human
Services (HHS).
ACTION: Notice of revision to the Privacy
Act system of records.
SUMMARY: HHS proposes to revise the
Privacy Act exempt system of records
09–37–0021, entitled ‘‘Public Health
Service Records Related to Inquiries and
Investigations of Scientific Misconduct,
HHS/OASH/ORI.’’ This system became
effective on August 29, 1994 (59 FR
36717, July 19, 1994). Changes were
made in response to comments received,
and the revised systems notice was
published on January 6, 1995 (60 FR
2140). The proposed revisions include
changing the routine uses and changing
the title of the system to ‘‘HHS Records
Related to Research Misconduct
Proceedings, HHS/OS/ORI.’’ The
revisions are necessary to reflect the
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changes made by the Public Health
Service Policies on Research
Misconduct (‘‘PHS Policies on Research
Misconduct’’), 42 CFR Part 93 (‘‘Part
93’’), and to update the system to reflect
current practices and procedures under
that regulation.
DATES: This notice will be effective
without further notice on September 30,
2009 unless modified by a subsequent
notice making changes in response to
public comments. Although the Privacy
Act requires only that changes in the
routine uses be published for comment,
HHS invites comments on all parts of
the systems notice. You may submit
comments by electronic mail to
AskORI@hhs.gov. Comments must be
received on or before September 30,
2009.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852. (240) 453–8800.
E-mail: AskORI@hhs.gov.
SUPPLEMENTARY INFORMATION: After
making changes in response to public
comments, ORI published its current
systems notice entitled ‘‘Public Health
Service Records Related to Inquiries and
Investigations of Scientific Misconduct,
HHS/OASH/ORI’’ on January 6, 1995
(60 FR 2140). Since that time, the
organizational location of ORI has
changed from the former Office of the
Assistant Secretary for Health to OPHS,
and a new HHS regulation concerning
research misconduct was promulgated
and codified at 42 CFR Part 93. That
regulation substantially changed the
previous regulation on scientific
misconduct (42 CFR Part 50, Subpart A),
including changing the term
‘‘misconduct in science’’ to ‘‘research
misconduct.’’
This revision updates the ORI system
notice to be consistent with the
definitions and procedures promulgated
by the PHS Policies on Research
Misconduct. The description of the
categories of individuals covered by the
records system and categories of records
in the system have been amended to
reflect the changes made by Part 93,
specifically, the applicability of that
part in terms of the individuals, types of
research, and types of PHS support that
are covered. Pertinent provisions of Part
93 are referenced to explain the records
system coverage. The category of
individuals covered by the system
remains the same: individuals who are
the subject of allegations of research
misconduct. Similarly, the categories of
records in the system remain essentially
the same: records related to all stages of
the research misconduct proceeding.
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The location of the system is now
limited to the premises of ORI and the
Federal Records Centers (for inactive
records). PHS officials outside of ORI
who are involved in extramural and
intramural research misconduct
proceedings have access to this system
of records as necessary to carry out their
duties.
We have amended the statement of
purposes to state more generally that
ORI will use the system of records to
exercise its oversight authority relating
to research misconduct proceedings,
and to document these activities.
The order of the routine uses has been
changed, and the terminology used has
been updated to reflect the terms used
in Part 93. The listing of routine uses
begins with disclosures that may be
made in the course of a research
misconduct proceeding in roughly the
order that they might occur, and ends
with disclosures that may be necessary
for more general administrative
purposes.
Routine use 1 is an expanded version
of routine uses 2 and 5 in the current
system notice. It now provides for
disclosure to a person able to ‘‘obtain’’
information, as well as provide
information or assistance, in a research
misconduct proceeding or related
proceeding, ORI oversight of an
institutional research misconduct
proceeding or ORI oversight of the
implementation of HHS administrative
actions. The reference to ORI oversight
functions has also been added. We have
also added a condition for each
disclosure under this routine use. Prior
to disclosure, ORI will determine
whether limited disclosures or
confidentiality agreements are needed to
protect the privacy of respondent(s),
complainant(s), witnesses, research
subjects or others who may be identified
in the records to be disclosed.
Routine use 2 is new. It is based on
42 CFR 93.401 that, in part, authorizes
ORI to notify and consult with other
Federal, State, or local offices, if ORI has
reason to believe that a research
misconduct proceeding may involve
that office. The second routine use in
the current system notice, relating to
disclosures to qualified experts, has
been deleted because that disclosure is
now covered by the more general
disclosure in the new routine uses 1 and
9.
Except for editorial changes, routine
use 3 is the same as use 8 in the current
system notice and routine use 4 is the
same as use 3 in the current notice.
Routine use 5 is new. It permits
additional disclosures after a final HHS/
ORI finding of research misconduct that
are aimed at conserving public funds,
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protecting Federal records, and
otherwise protecting the interests of the
Federal Government.
Routine use 6 is an amended version
of use 10 in the current notice. We have
moved ‘‘after * * * a final HHS/ORI
finding of research misconduct’’ to the
front, deleted the reference to remedial
actions, and minimally expanded the
list of those to whom disclosures may be
made.
Routine use 7 is an amended version
of use 6 in the current notice. We have
moved the reference to an HHS/ORI
finding of research misconduct to the
front, added ‘‘final’’ to it, deleted the
reference to the imposition of remedial
actions, and added ‘‘other similar
entity.’’ Use 7 in the current notice,
disclosures to IRBs, research sponsoring
institutions, research subjects, and the
public has been deleted, because these
types of disclosures would now
normally be made by the institutions
and, in any case, these types of
disclosures would be covered by the
more general disclosure covered by new
routine uses 2 and 3.
Routine use 8 is an amended version
of routine use 11 in the current notice.
We have added a reference to
suspension actions and a reference to
the General Services Administration’s
(GSA’s) Excluded Parties List System.
Routine use 9 is essentially the same
as routine use 9 in the current notice. It
permits disclosures to volunteers and
contractors engaged by ORI in support
of its research misconduct oversight
functions, if they need access to the
records to perform their assigned tasks
for the agency; provided, however, that
in each case ORI determines whether
limited disclosures or confidentiality
agreements are needed to protect the
privacy of respondent(s),
complainant(s), witnesses, research
subjects or others who may be identified
in the records to be disclosed. Routine
use 10 is authorized by 42 CFR
93.410(a) to permit disclosure in cases
that do not result in an ORI finding of
research misconduct and that ORI
decides to close.
Routine uses 11 and 12 are derived
from use 1 in the current notice. That
previous use addressed both disclosures
to the Department of Justice (DOJ) and
to courts or other tribunals. Routine use
11 addresses disclosures to the DOJ and
routine use 12 addresses disclosure to
courts or other tribunals. In addition,
the language has been clarified.
The description of record source
categories has been revised to describe
more accurately the many sources from
which the records are received or
obtained. Other changes to improve
accuracy, update information, terms,
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and citations, and clarify language have
been made throughout the systems
notice.
This record system remains exempt
from certain requirements of the Privacy
Act in accordance with the
Department’s determination published
in the system notice. (59 FR 36717, July
19, 1994).
Dated: August 14, 2009.
Donald Wright,
Principal Deputy Assistant Secretary for
Health.
09–37–0021
SYSTEM NAME:
HHS Records Related to Research
Misconduct Proceedings, HHS/OS/ORI.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION(S):
Office of Research Integrity, 1101
Wootton Parkway, Suite 750, Rockville,
MD 20852, and Federal Records Centers
for inactive, permanent records.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The individuals covered by this
system are referred to as ‘‘respondents.’’
Part 93 defines the term ‘‘respondent’’ to
mean ‘‘the person against whom an
allegation of research misconduct is
directed or who is the subject of a
research misconduct proceeding.’’ 42
CFR 93.225.
Part 93 and this system notice apply
to an allegation of research misconduct
involving: (1) Applications or proposals
for PHS support for biomedical or
behavioral extramural or intramural
research, research training or activities
related to that research or research
training, such as the operation of tissue
and data banks and the dissemination of
research information; (2) PHS supported
biomedical or behavioral extramural or
intramural research; (3) PHS supported
biomedical or behavioral extramural or
intramural research training programs;
(4) PHS supported extramural or
intramural activities that are related to
biomedical or behavioral research or
research training; and (5) plagiarism of
research records produced in the course
of PHS supported research, research
training or activities related to that
research or research training.
The term ‘‘research misconduct’’ is
defined to mean ‘‘fabrication,
falsification, or plagiarism in proposing,
performing, or reviewing research, or in
reporting research results.’’
‘‘Fabrication’’ is defined to mean
‘‘making up data or results and
recording or reporting them.’’
‘‘Falsification’’ is ‘‘manipulating
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research materials, equipment, or
processes, or changing or omitting data
or results such that the research is not
accurately represented in the research
record.’’ ‘‘Plagiarism’’ is ‘‘the
appropriation of another person’s ideas,
processes, results, or words without
giving appropriate credit.’’ Research
misconduct does not include honest
error or differences of opinion. 42 CFR
93.103.
CATEGORIES OF RECORDS IN THE SYSTEM:
This system contains records related
to research misconduct proceedings.
The term ‘‘research misconduct
proceeding’’ is defined to mean ‘‘any
actions related to alleged research
misconduct taken under this part, [Part
93] including but not limited to
allegation assessments, inquiries,
investigations, ORI oversight reviews,
hearings, and administrative appeals.’’
42 CFR 93.223.
The records include all information
that must be submitted to ORI by
institutions under Part 93 in connection
with a research misconduct proceeding,
and all information that ORI receives or
generates in overseeing or conducting
research misconduct proceedings. This
information includes, but is not
necessarily limited to information about
respondents (this may include social
security numbers), complainants, and
witnesses; the nature of the allegations;
the PHS funding involved, including
grant numbers; the institutions and
officials responsible for conducting the
actions that are part of the research
misconduct proceeding; the
documentation used in the inquiry and
investigation, including relevant
research data and materials,
applications, proposals and
documentation related to review and
award actions, reports, abstracts,
manuscripts and publications by the
respondent(s) and other relevant
reports, abstracts, manuscripts and
publications, correspondence;
memoranda of telephone calls,
summaries of interviews and transcripts
or recordings of interviews; statistical,
scientific, and forensic analyses; interim
and final institutional reports, and
records of institutional appeal
proceedings, if any.
The system also includes records
relating to: (1) ORI oversight of
institutional assessments, inquiries and
investigations, ORI findings of research
misconduct, and ORI proposals for HHS
administrative actions or for settlement
of the case; (2) final HHS findings of
research misconduct, final HHS
decisions regarding administrative
actions, and documentation of the
implementation of those actions; and (3)
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ORI coordination with other Federal,
State, and local offices/agencies,
including the Department of Justice.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The authorities for maintaining the
system are: Sections 301 and 493 of the
Public Health Service Act, 42 U.S.C.
241, and 289b; 5 U.S.C. 552a, 5 U.S.C.
301 and 44 U.S.C. 3101; 42 CFR Part 93;
2 CFR Part 376; 48 CFR Subpart 309.4.
PURPOSE(S):
The purposes of this system are to:
(1) Enable HHS, ORI, and the Federal
Government to protect the health and
safety of the public, to promote the
integrity of PHS supported research, and
to conserve public funds;
(2) Enable ORI to implement its
authority relating to research
misconduct proceedings as set forth in
42 U.S.C. 289b and 42 CFR Part 93, and
to document HHS and ORI activities in
implementing that authority;
(3) Ensure that research misconduct
proceedings, including institutional
implementation of HHS administrative
actions, are carried out in accordance
with 42 CFR Part 93 and other
applicable Federal statutes and
regulations;
(4) Enable ORI to inform PHS agency
officials who have a need for the records
in the performance of their duties, of the
status and results of research
misconduct proceedings; and
(5) Enable ORI to notify, consult with,
and provide assistance to other Federal,
State, or local governmental agencies to
permit them to take action to protect the
health and safety of the public, to
promote the integrity of PHS supported
research, to conserve public funds, or to
pursue potential violations of civil and
criminal statutes.
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ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM INCLUDING THE PURPOSES OF SUCH USES
AND CATEGORIES OF USERS:
The HHS Privacy Act regulation lists,
at 45 CFR 5b.9(b), disclosures of records
that may be made without the consent
of the individual who is the subject of
the records. Among the permitted
disclosures are disclosures to those
officers and employees of the
Department who have a need for the
record in the performance of their duties
and routine uses that are listed in the
notice of the system of records. A
‘‘routine use’’ is defined in 45 CFR 5.1(j)
to mean ‘‘the disclosure of a record
outside the Department, without the
consent of the subject individual, for a
purpose which is compatible with the
purpose for which the record was
collected.’’ The routine uses for this
system of records are listed below.
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1. Disclosure may be made to any
person able to obtain information or
provide information or assistance in a
research misconduct proceeding or
related proceeding, ORI oversight of an
institutional research misconduct
proceeding, or ORI oversight of the
implementation of HHS administrative
actions. Recipients of disclosures under
this routine use may include experts
asked to perform statistical, forensic or
other analyses, the relevant PHS
supported institution(s), institutions
with which the respondent(s) was
previously or is currently affiliated,
Federal, State and local agencies, the
respondent(s), the complainant(s),
witnesses, and organizations or
individuals acting on behalf of those
agencies, institutions and individuals;
provided, however, that in each case
ORI determines whether limited
disclosures or confidentiality
agreements are needed to protect the
privacy of respondent(s),
complainant(s), witnesses, research
subjects or others who may be identified
in the records to be disclosed.
2. Disclosure may be made to other
Federal, State, or local agencies and
offices, if ORI has reason to believe that
a research misconduct proceeding may
involve that agency or office.
3. When a record on its face, or in
conjunction with other records,
indicates a violation or potential
violation of law, whether civil, criminal
or regulatory in nature, disclosure may
be made to the appropriate agency,
whether Federal, foreign, State, local or
Tribal, or other public authority
responsible for enforcing, investigating
or prosecuting such violation, if the
information disclosed is relevant to the
responsibilities of the agency or public
authority.
4. Disclosure may be made to
responsible officials of PHS-supported
institutions or organizations, when in
connection with a research misconduct
proceeding concerning an individual
previously or currently employed by, or
affiliated with the institution or
organization, or when ORI or HHS
makes a finding or takes an action
potentially affecting the institution or
organization or its PHS support for
research, research training, or related
activities.
5. After there is a final HHS/ORI
finding of research misconduct,
disclosure may be made to a Federal,
State, local or Tribal agency in
connection with the hiring or retention
of an employee, the issuance of a
security clearance, the reporting of an
investigation of an employee, or the
issuance of a license or other benefit by
the agency, to the extent that the record
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44849
is relevant to the agency’s decision on
the matter.
6. After there is a final HHS/ORI
finding of research misconduct,
disclosure may be made to professional
journals, other publications, news
media, other individuals and entities,
and the public concerning research
misconduct findings and the need to
correct or retract research results or
reports that have been affected by
research misconduct. No information
will be released that would reveal a
confidential source.
7. After there is a final HHS/ORI
finding of research misconduct,
disclosure may be made to a State
licensing board, certifying body, or
other similar entity conducting a review
of the respondent, to aid the entity in
meeting its responsibility to protect the
health of the population in its
jurisdiction or the integrity of the
profession.
8. After there is an HHS decision to
suspend, or a final HHS decision to
debar the respondent from Federal
procurement and nonprocurement
programs, disclosure may be made to
GSA for the purpose of adding the
respondent to GSA’s Excluded Parties
List System.
9. Disclosure may be made to
volunteers and contractors engaged to
perform a service in support of an ORI
research misconduct oversight function,
if such persons need access to the
records to perform their assigned task;
provided, however, in each case ORI
determines whether limited disclosures
or confidentiality agreements are
needed to protect the privacy of
respondent(s), complainant(s),
witnesses, research subjects or others
who may be identified in the records to
be disclosed; and ORI determines that
the disclosure is for a purpose
compatible with the purpose for which
the agency collected the records.
10. When ORI closes a case without
a settlement or finding of research
misconduct, disclosure may be made to
the respondent, relevant institution, and
complainant(s); provided, however, that
in each case ORI determines whether
limited disclosures or confidentiality
agreements are needed to protect the
privacy of respondent(s),
complainant(s), witnesses, research
subjects or others who may be identified
in the records to be disclosed.
11. Disclosure may be made to DOJ
when: (a) The agency or any component
thereof; or (b) any employee of the
agency in his or her official capacity
where the DOJ has agreed to represent
the employee; or (c) the United States
Government, is a party to litigation or
has an interest in such litigation and,
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prior to disclosure, the agency
determines that the records are both
relevant and necessary to the litigation
and the use of such records by the DOJ
is therefore deemed by the agency to be
for a purpose that is compatible with the
purpose for which the agency collected
the records.
12. Disclosure may be made to a court
or other tribunal, when: (a) The agency
or any component thereof; or (b) any
employee of the agency in his or her
official capacity where the DOJ has
agreed to represent the employee; or (c)
the United States Government is a party
to the proceeding or has an interest in
such proceeding and, prior to
disclosure, the agency determines that
the records are both relevant and
necessary to the proceeding and the use
of such records is therefore deemed by
the agency to be for a purpose that is
compatible with the purpose for which
the agency collected the records.
2. Procedural safeguards: Access is
strictly controlled by the system
manager and the Director, ORI, 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 the system
manager.
3. Physical safeguards: ORI 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. The ORI office
suite is protected by access and
intrusion alarms at the front and
emergency entrances. 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.
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
RETENTION AND DISPOSAL:
The files are retained and disposed of
in accordance with the General Records
Schedule (accessions) and a disposition
schedule approved by the National
Archives and Records Administration
(cases).
STORAGE:
Records are stored in file folders,
electronic and magnetic media and
other types of data storage devices.
SYSTEM MANAGER AND ADDRESS:
RETRIEVABILITY:
Records are retrieved by manual or
computer search of the case-tracking
system using the name of the
respondent(s) (i.e., the individual or
individuals who are the subject of an
allegation of research misconduct or of
a research misconduct proceeding).
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SAFEGUARDS:
1. Authorized users: Records are
available to the system manager, to the
Director, ORI, and to other appropriate
ORI staff when they have a need for the
records in the performance of their
duties. Records are also available to the
head of intramural research for the PHS
agency involved, and to other
appropriate HHS officials, including
attorneys in the Office of the General
Counsel, the Agency Research Integrity
Liaison Officer (ARILOs), the Agency
Intramural Research Integrity Officer
(AIRIOs), the Agency Extramural
Research Integrity Officer (AERIOs), and
the Research Integrity Officers (RIOs)
located in the Institutes and Centers of
the National Institutes of Health (NIH)
that are involved in the research
misconduct proceeding, 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.
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Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852.
NOTIFICATION PROCEDURES:
This system is exempt from access;
however, consideration will be given to
requests addressed to the system
manager. The requester must verify his
or her identity by providing either a
notarization of the request or a written
certification that the requester is who he
or she claims to be and understands that
the knowing and willful request for
acquisition of a record pertaining to an
individual under false pretenses is a
criminal offense under the Privacy Act,
subject to a five thousand dollar fine.
The request should include: (a) Full
name, (b) address, and (c) year of
records in question.
RECORD ACCESS PROCEDURES:
Same as notification procedures.
Requesters should reasonably specify
the record contents being sought.
Although the system is exempt,
respondents may, upon request, receive
records from this system and an
accounting of disclosure of their
records, if the system manager
determines the disclosure would not
compromise the activities of ORI or the
confidentiality of information.
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CONTESTING RECORD PROCEDURES:
Exempt. However, consideration may
be given to requests addressed to the
system manager. Requests for
corrections should reasonably identify
the record and specify the information
to be contested, the corrective action
sought and the reasons for the
corrections with supporting
justification. The right to contest records
is limited to information that is
incomplete, irrelevant, incorrect, or
obsolete.
RECORD SOURCE CATEGORIES:
Information in this system is received
or obtained from many sources,
including: (1) Directly from the
respondent or complainant or his/her
representative; (2) derived from
materials supplied by the respondent or
complainant or his/her representative;
(3) from information supplied by the
institutions, witnesses, scientific
publications and other
nongovernmental sources; (4) from
observation and analysis made by ORI
staff and scientific experts; (5)
departmental and other Federal, State,
and local government records; (6) from
hearings and other administrative
proceedings; and (7) from any other
relevant source.
SYSTEM EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
This system is exempted pursuant to
5 U.S.C. 552a(k)(2) and (k)(5) of the
Privacy Act from access, notification,
correction, and amendment provisions
of the Act (5 U.S.C. 552a(c)(3), (d)(1)–
(4), (e)(4)(G)–(H), and (f)).
[FR Doc. E9–20893 Filed 8–28–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
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[Federal Register Volume 74, Number 167 (Monday, August 31, 2009)]
[Notices]
[Pages 44847-44850]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20893]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Research Integrity; Privacy Act of 1974; Report of an
Altered System of Records
AGENCY: Office of Research Integrity (ORI), Office of Public Health and
Science (OPHS), Office of the Secretary (OS), Department of Health and
Human Services (HHS).
ACTION: Notice of revision to the Privacy Act system of records.
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SUMMARY: HHS proposes to revise the Privacy Act exempt system of
records 09-37-0021, entitled ``Public Health Service Records Related to
Inquiries and Investigations of Scientific Misconduct, HHS/OASH/ORI.''
This system became effective on August 29, 1994 (59 FR 36717, July 19,
1994). Changes were made in response to comments received, and the
revised systems notice was published on January 6, 1995 (60 FR 2140).
The proposed revisions include changing the routine uses and changing
the title of the system to ``HHS Records Related to Research Misconduct
Proceedings, HHS/OS/ORI.'' The revisions are necessary to reflect the
changes made by the Public Health Service Policies on Research
Misconduct (``PHS Policies on Research Misconduct''), 42 CFR Part 93
(``Part 93''), and to update the system to reflect current practices
and procedures under that regulation.
DATES: This notice will be effective without further notice on
September 30, 2009 unless modified by a subsequent notice making
changes in response to public comments. Although the Privacy Act
requires only that changes in the routine uses be published for
comment, HHS invites comments on all parts of the systems notice. You
may submit comments by electronic mail to AskORI@hhs.gov. Comments must
be received on or before September 30, 2009.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852. (240) 453-8800. E-mail: AskORI@hhs.gov.
SUPPLEMENTARY INFORMATION: After making changes in response to public
comments, ORI published its current systems notice entitled ``Public
Health Service Records Related to Inquiries and Investigations of
Scientific Misconduct, HHS/OASH/ORI'' on January 6, 1995 (60 FR 2140).
Since that time, the organizational location of ORI has changed from
the former Office of the Assistant Secretary for Health to OPHS, and a
new HHS regulation concerning research misconduct was promulgated and
codified at 42 CFR Part 93. That regulation substantially changed the
previous regulation on scientific misconduct (42 CFR Part 50, Subpart
A), including changing the term ``misconduct in science'' to ``research
misconduct.''
This revision updates the ORI system notice to be consistent with
the definitions and procedures promulgated by the PHS Policies on
Research Misconduct. The description of the categories of individuals
covered by the records system and categories of records in the system
have been amended to reflect the changes made by Part 93, specifically,
the applicability of that part in terms of the individuals, types of
research, and types of PHS support that are covered. Pertinent
provisions of Part 93 are referenced to explain the records system
coverage. The category of individuals covered by the system remains the
same: individuals who are the subject of allegations of research
misconduct. Similarly, the categories of records in the system remain
essentially the same: records related to all stages of the research
misconduct proceeding.
The location of the system is now limited to the premises of ORI
and the Federal Records Centers (for inactive records). PHS officials
outside of ORI who are involved in extramural and intramural research
misconduct proceedings have access to this system of records as
necessary to carry out their duties.
We have amended the statement of purposes to state more generally
that ORI will use the system of records to exercise its oversight
authority relating to research misconduct proceedings, and to document
these activities.
The order of the routine uses has been changed, and the terminology
used has been updated to reflect the terms used in Part 93. The listing
of routine uses begins with disclosures that may be made in the course
of a research misconduct proceeding in roughly the order that they
might occur, and ends with disclosures that may be necessary for more
general administrative purposes.
Routine use 1 is an expanded version of routine uses 2 and 5 in the
current system notice. It now provides for disclosure to a person able
to ``obtain'' information, as well as provide information or
assistance, in a research misconduct proceeding or related proceeding,
ORI oversight of an institutional research misconduct proceeding or ORI
oversight of the implementation of HHS administrative actions. The
reference to ORI oversight functions has also been added. We have also
added a condition for each disclosure under this routine use. Prior to
disclosure, ORI will determine whether limited disclosures or
confidentiality agreements are needed to protect the privacy of
respondent(s), complainant(s), witnesses, research subjects or others
who may be identified in the records to be disclosed.
Routine use 2 is new. It is based on 42 CFR 93.401 that, in part,
authorizes ORI to notify and consult with other Federal, State, or
local offices, if ORI has reason to believe that a research misconduct
proceeding may involve that office. The second routine use in the
current system notice, relating to disclosures to qualified experts,
has been deleted because that disclosure is now covered by the more
general disclosure in the new routine uses 1 and 9.
Except for editorial changes, routine use 3 is the same as use 8 in
the current system notice and routine use 4 is the same as use 3 in the
current notice.
Routine use 5 is new. It permits additional disclosures after a
final HHS/ORI finding of research misconduct that are aimed at
conserving public funds,
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protecting Federal records, and otherwise protecting the interests of
the Federal Government.
Routine use 6 is an amended version of use 10 in the current
notice. We have moved ``after * * * a final HHS/ORI finding of research
misconduct'' to the front, deleted the reference to remedial actions,
and minimally expanded the list of those to whom disclosures may be
made.
Routine use 7 is an amended version of use 6 in the current notice.
We have moved the reference to an HHS/ORI finding of research
misconduct to the front, added ``final'' to it, deleted the reference
to the imposition of remedial actions, and added ``other similar
entity.'' Use 7 in the current notice, disclosures to IRBs, research
sponsoring institutions, research subjects, and the public has been
deleted, because these types of disclosures would now normally be made
by the institutions and, in any case, these types of disclosures would
be covered by the more general disclosure covered by new routine uses 2
and 3.
Routine use 8 is an amended version of routine use 11 in the
current notice. We have added a reference to suspension actions and a
reference to the General Services Administration's (GSA's) Excluded
Parties List System.
Routine use 9 is essentially the same as routine use 9 in the
current notice. It permits disclosures to volunteers and contractors
engaged by ORI in support of its research misconduct oversight
functions, if they need access to the records to perform their assigned
tasks for the agency; provided, however, that in each case ORI
determines whether limited disclosures or confidentiality agreements
are needed to protect the privacy of respondent(s), complainant(s),
witnesses, research subjects or others who may be identified in the
records to be disclosed. Routine use 10 is authorized by 42 CFR
93.410(a) to permit disclosure in cases that do not result in an ORI
finding of research misconduct and that ORI decides to close.
Routine uses 11 and 12 are derived from use 1 in the current
notice. That previous use addressed both disclosures to the Department
of Justice (DOJ) and to courts or other tribunals. Routine use 11
addresses disclosures to the DOJ and routine use 12 addresses
disclosure to courts or other tribunals. In addition, the language has
been clarified.
The description of record source categories has been revised to
describe more accurately the many sources from which the records are
received or obtained. Other changes to improve accuracy, update
information, terms, and citations, and clarify language have been made
throughout the systems notice.
This record system remains exempt from certain requirements of the
Privacy Act in accordance with the Department's determination published
in the system notice. (59 FR 36717, July 19, 1994).
Dated: August 14, 2009.
Donald Wright,
Principal Deputy Assistant Secretary for Health.
09-37-0021
SYSTEM NAME:
HHS Records Related to Research Misconduct Proceedings, HHS/OS/ORI.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION(S):
Office of Research Integrity, 1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, and Federal Records Centers for inactive,
permanent records.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The individuals covered by this system are referred to as
``respondents.'' Part 93 defines the term ``respondent'' to mean ``the
person against whom an allegation of research misconduct is directed or
who is the subject of a research misconduct proceeding.'' 42 CFR
93.225.
Part 93 and this system notice apply to an allegation of research
misconduct involving: (1) Applications or proposals for PHS support for
biomedical or behavioral extramural or intramural research, research
training or activities related to that research or research training,
such as the operation of tissue and data banks and the dissemination of
research information; (2) PHS supported biomedical or behavioral
extramural or intramural research; (3) PHS supported biomedical or
behavioral extramural or intramural research training programs; (4) PHS
supported extramural or intramural activities that are related to
biomedical or behavioral research or research training; and (5)
plagiarism of research records produced in the course of PHS supported
research, research training or activities related to that research or
research training.
The term ``research misconduct'' is defined to mean ``fabrication,
falsification, or plagiarism in proposing, performing, or reviewing
research, or in reporting research results.'' ``Fabrication'' is
defined to mean ``making up data or results and recording or reporting
them.'' ``Falsification'' is ``manipulating research materials,
equipment, or processes, or changing or omitting data or results such
that the research is not accurately represented in the research
record.'' ``Plagiarism'' is ``the appropriation of another person's
ideas, processes, results, or words without giving appropriate
credit.'' Research misconduct does not include honest error or
differences of opinion. 42 CFR 93.103.
CATEGORIES OF RECORDS IN THE SYSTEM:
This system contains records related to research misconduct
proceedings. The term ``research misconduct proceeding'' is defined to
mean ``any actions related to alleged research misconduct taken under
this part, [Part 93] including but not limited to allegation
assessments, inquiries, investigations, ORI oversight reviews,
hearings, and administrative appeals.'' 42 CFR 93.223.
The records include all information that must be submitted to ORI
by institutions under Part 93 in connection with a research misconduct
proceeding, and all information that ORI receives or generates in
overseeing or conducting research misconduct proceedings. This
information includes, but is not necessarily limited to information
about respondents (this may include social security numbers),
complainants, and witnesses; the nature of the allegations; the PHS
funding involved, including grant numbers; the institutions and
officials responsible for conducting the actions that are part of the
research misconduct proceeding; the documentation used in the inquiry
and investigation, including relevant research data and materials,
applications, proposals and documentation related to review and award
actions, reports, abstracts, manuscripts and publications by the
respondent(s) and other relevant reports, abstracts, manuscripts and
publications, correspondence; memoranda of telephone calls, summaries
of interviews and transcripts or recordings of interviews; statistical,
scientific, and forensic analyses; interim and final institutional
reports, and records of institutional appeal proceedings, if any.
The system also includes records relating to: (1) ORI oversight of
institutional assessments, inquiries and investigations, ORI findings
of research misconduct, and ORI proposals for HHS administrative
actions or for settlement of the case; (2) final HHS findings of
research misconduct, final HHS decisions regarding administrative
actions, and documentation of the implementation of those actions; and
(3)
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ORI coordination with other Federal, State, and local offices/agencies,
including the Department of Justice.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The authorities for maintaining the system are: Sections 301 and
493 of the Public Health Service Act, 42 U.S.C. 241, and 289b; 5 U.S.C.
552a, 5 U.S.C. 301 and 44 U.S.C. 3101; 42 CFR Part 93; 2 CFR Part 376;
48 CFR Subpart 309.4.
PURPOSE(S):
The purposes of this system are to:
(1) Enable HHS, ORI, and the Federal Government to protect the
health and safety of the public, to promote the integrity of PHS
supported research, and to conserve public funds;
(2) Enable ORI to implement its authority relating to research
misconduct proceedings as set forth in 42 U.S.C. 289b and 42 CFR Part
93, and to document HHS and ORI activities in implementing that
authority;
(3) Ensure that research misconduct proceedings, including
institutional implementation of HHS administrative actions, are carried
out in accordance with 42 CFR Part 93 and other applicable Federal
statutes and regulations;
(4) Enable ORI to inform PHS agency officials who have a need for
the records in the performance of their duties, of the status and
results of research misconduct proceedings; and
(5) Enable ORI to notify, consult with, and provide assistance to
other Federal, State, or local governmental agencies to permit them to
take action to protect the health and safety of the public, to promote
the integrity of PHS supported research, to conserve public funds, or
to pursue potential violations of civil and criminal statutes.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM INCLUDING THE PURPOSES
OF SUCH USES AND CATEGORIES OF USERS:
The HHS Privacy Act regulation lists, at 45 CFR 5b.9(b),
disclosures of records that may be made without the consent of the
individual who is the subject of the records. Among the permitted
disclosures are disclosures to those officers and employees of the
Department who have a need for the record in the performance of their
duties and routine uses that are listed in the notice of the system of
records. A ``routine use'' is defined in 45 CFR 5.1(j) to mean ``the
disclosure of a record outside the Department, without the consent of
the subject individual, for a purpose which is compatible with the
purpose for which the record was collected.'' The routine uses for this
system of records are listed below.
1. Disclosure may be made to any person able to obtain information
or provide information or assistance in a research misconduct
proceeding or related proceeding, ORI oversight of an institutional
research misconduct proceeding, or ORI oversight of the implementation
of HHS administrative actions. Recipients of disclosures under this
routine use may include experts asked to perform statistical, forensic
or other analyses, the relevant PHS supported institution(s),
institutions with which the respondent(s) was previously or is
currently affiliated, Federal, State and local agencies, the
respondent(s), the complainant(s), witnesses, and organizations or
individuals acting on behalf of those agencies, institutions and
individuals; provided, however, that in each case ORI determines
whether limited disclosures or confidentiality agreements are needed to
protect the privacy of respondent(s), complainant(s), witnesses,
research subjects or others who may be identified in the records to be
disclosed.
2. Disclosure may be made to other Federal, State, or local
agencies and offices, if ORI has reason to believe that a research
misconduct proceeding may involve that agency or office.
3. When a record on its face, or in conjunction with other records,
indicates a violation or potential violation of law, whether civil,
criminal or regulatory in nature, disclosure may be made to the
appropriate agency, whether Federal, foreign, State, local or Tribal,
or other public authority responsible for enforcing, investigating or
prosecuting such violation, if the information disclosed is relevant to
the responsibilities of the agency or public authority.
4. Disclosure may be made to responsible officials of PHS-supported
institutions or organizations, when in connection with a research
misconduct proceeding concerning an individual previously or currently
employed by, or affiliated with the institution or organization, or
when ORI or HHS makes a finding or takes an action potentially
affecting the institution or organization or its PHS support for
research, research training, or related activities.
5. After there is a final HHS/ORI finding of research misconduct,
disclosure may be made to a Federal, State, local or Tribal agency in
connection with the hiring or retention of an employee, the issuance of
a security clearance, the reporting of an investigation of an employee,
or the issuance of a license or other benefit by the agency, to the
extent that the record is relevant to the agency's decision on the
matter.
6. After there is a final HHS/ORI finding of research misconduct,
disclosure may be made to professional journals, other publications,
news media, other individuals and entities, and the public concerning
research misconduct findings and the need to correct or retract
research results or reports that have been affected by research
misconduct. No information will be released that would reveal a
confidential source.
7. After there is a final HHS/ORI finding of research misconduct,
disclosure may be made to a State licensing board, certifying body, or
other similar entity conducting a review of the respondent, to aid the
entity in meeting its responsibility to protect the health of the
population in its jurisdiction or the integrity of the profession.
8. After there is an HHS decision to suspend, or a final HHS
decision to debar the respondent from Federal procurement and
nonprocurement programs, disclosure may be made to GSA for the purpose
of adding the respondent to GSA's Excluded Parties List System.
9. Disclosure may be made to volunteers and contractors engaged to
perform a service in support of an ORI research misconduct oversight
function, if such persons need access to the records to perform their
assigned task; provided, however, in each case ORI determines whether
limited disclosures or confidentiality agreements are needed to protect
the privacy of respondent(s), complainant(s), witnesses, research
subjects or others who may be identified in the records to be
disclosed; and ORI determines that the disclosure is for a purpose
compatible with the purpose for which the agency collected the records.
10. When ORI closes a case without a settlement or finding of
research misconduct, disclosure may be made to the respondent, relevant
institution, and complainant(s); provided, however, that in each case
ORI determines whether limited disclosures or confidentiality
agreements are needed to protect the privacy of respondent(s),
complainant(s), witnesses, research subjects or others who may be
identified in the records to be disclosed.
11. Disclosure may be made to DOJ when: (a) The agency or any
component thereof; or (b) any employee of the agency in his or her
official capacity where the DOJ has agreed to represent the employee;
or (c) the United States Government, is a party to litigation or has an
interest in such litigation and,
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prior to disclosure, the agency determines that the records are both
relevant and necessary to the litigation and the use of such records by
the DOJ is therefore deemed by the agency to be for a purpose that is
compatible with the purpose for which the agency collected the records.
12. Disclosure may be made to a court or other tribunal, when: (a)
The agency or any component thereof; or (b) any employee of the agency
in his or her official capacity where the DOJ has agreed to represent
the employee; or (c) the United States Government is a party to the
proceeding or has an interest in such proceeding and, prior to
disclosure, the agency determines that the records are both relevant
and necessary to the proceeding and the use of such records is
therefore deemed by the agency to be for a purpose that is compatible
with the purpose for which the agency collected the records.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored in file folders, electronic and magnetic media
and other types of data storage devices.
RETRIEVABILITY:
Records are retrieved by manual or computer search of the case-
tracking system using the name of the respondent(s) (i.e., the
individual or individuals who are the subject of an allegation of
research misconduct or of a research misconduct proceeding).
SAFEGUARDS:
1. Authorized users: Records are available to the system manager,
to the Director, ORI, and to other appropriate ORI staff when they have
a need for the records in the performance of their duties. Records are
also available to the head of intramural research for the PHS agency
involved, and to other appropriate HHS officials, including attorneys
in the Office of the General Counsel, the Agency Research Integrity
Liaison Officer (ARILOs), the Agency Intramural Research Integrity
Officer (AIRIOs), the Agency Extramural Research Integrity Officer
(AERIOs), and the Research Integrity Officers (RIOs) located in the
Institutes and Centers of the National Institutes of Health (NIH) that
are involved in the research misconduct proceeding, 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 the
system manager and the Director, ORI, 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 the system manager.
3. Physical safeguards: ORI 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. The ORI office suite is
protected by access and intrusion alarms at the front and emergency
entrances. 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 files are retained and disposed of in accordance with the
General Records Schedule (accessions) and a disposition schedule
approved by the National Archives and Records Administration (cases).
SYSTEM MANAGER AND ADDRESS:
Director, Division of Investigative Oversight, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852.
NOTIFICATION PROCEDURES:
This system is exempt from access; however, consideration will be
given to requests addressed to the system manager. The requester must
verify his or her identity by providing either a notarization of the
request or a written certification that the requester is who he or she
claims to be and understands that the knowing and willful request for
acquisition of a record pertaining to an individual under false
pretenses is a criminal offense under the Privacy Act, subject to a
five thousand dollar fine. The request should include: (a) Full name,
(b) address, and (c) year of records in question.
RECORD ACCESS PROCEDURES:
Same as notification procedures. Requesters should reasonably
specify the record contents being sought. Although the system is
exempt, respondents may, upon request, receive records from this system
and an accounting of disclosure of their records, if the system manager
determines the disclosure would not compromise the activities of ORI or
the confidentiality of information.
CONTESTING RECORD PROCEDURES:
Exempt. However, consideration may be given to requests addressed
to the system manager. Requests for corrections should reasonably
identify the record and specify the information to be contested, the
corrective action sought and the reasons for the corrections with
supporting justification. The right to contest records is limited to
information that is incomplete, irrelevant, incorrect, or obsolete.
RECORD SOURCE CATEGORIES:
Information in this system is received or obtained from many
sources, including: (1) Directly from the respondent or complainant or
his/her representative; (2) derived from materials supplied by the
respondent or complainant or his/her representative; (3) from
information supplied by the institutions, witnesses, scientific
publications and other nongovernmental sources; (4) from observation
and analysis made by ORI staff and scientific experts; (5) departmental
and other Federal, State, and local government records; (6) from
hearings and other administrative proceedings; and (7) from any other
relevant source.
SYSTEM EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
This system is exempted pursuant to 5 U.S.C. 552a(k)(2) and (k)(5)
of the Privacy Act from access, notification, correction, and amendment
provisions of the Act (5 U.S.C. 552a(c)(3), (d)(1)-(4), (e)(4)(G)-(H),
and (f)).
[FR Doc. E9-20893 Filed 8-28-09; 8:45 am]
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