Privacy Act of 1974; Proposed Exempt New System of Records, 52043-52047 [2012-20884]
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Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Notices
Among Racial and Ethnic Minority-PA10–
236.
Date: October 9, 2012.
Time: 2 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Najma Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 749, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK KUH
Fellowship Grant Applications Review.
Date: October 12, 2012.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building Sixty, 9000 Rockville Pike, Room
144, Rockville, MD 20892.
Contact Person: Xiaodu Guo, Md, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 761, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–4719,
guox@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Fellowships of
Digestive Diseases and Nutrition.
Date: October 18–19, 2012.
Time: 8:30 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street
NW., Washington, DC 20036.
Contact Person: Thomas A. Tatham, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 760, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–3993,
tathamt@mail.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; DDK–C Conflicts.
Date: October 18, 2012.
Time: 4 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street
NW., Washington, DC 20036.
Contact Person: Thomas A. Tatham, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 760, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–3993,
tathamt@mail.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Nutrition Obesity
Research Centers (P30).
Date: November 12, 2012.
Time: 8:30 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz Carlton Hotel, 1150 22nd Street
NW., Washington, DC 20037.
Contact Person: Thomas A. Tatham, Ph.D.,
Scientific Review Officer, Review Branch,
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DEA, NIDDK, National Institutes of Health,
Room 760, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–3993,
tathamt@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: August 22, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–21121 Filed 8–27–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Privacy Act of 1974; Proposed Exempt
New System of Records
National Institutes of Health
(NIH), Department of Health and Human
Services (DHHS).
ACTION: Notification of a proposed
exempt new system of records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended (Privacy Act), the National
Institutes of Health (NIH) is proposing
to establish an exempt new system of
records, 09–25–0223, ‘‘NIH Records
Related to Research Misconduct
Proceedings, HHS/NIH.’’ The new
system will contain records pertaining
to individual respondents who are the
subject of research misconduct
allegations or proceedings governed by
the Public Health Service (PHS) Policies
on Research Misconduct (‘‘PHS Policies
on Research Misconduct’’), 42 CFR Part
93 (‘‘Part 93’’). Because this is a law
enforcement investigatory system, NIH
has published a Notice of Proposed
Rulemaking to exempt the system from
certain requirements of the Privacy Act;
specifically, the provisions pertaining to
providing an accounting of disclosures,
access and amendment, notification,
and agency procedures and rules.
DATES: The new system of records will
be effective on the date of publication of
this notice, with the exception of the
routine uses and the requested
exemptions. The routine uses will
become effective on October 12, 2012.
As detailed in the related rulemaking
notices published elsewhere in the
Federal Register, unless revised or
withdrawn in response to comments,
the requested exemptions will become
effective 135 days after publication of
the rulemaking notices. Submit either
SUMMARY:
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52043
electronic or written comments
regarding this notice by October 12,
2012. The NIH has sent a Report of the
Proposed Exempt New System to the
Congress and to the Office of
Management and Budget (OMB).
ADDRESSEES: You may submit
comments, identified by the Privacy Act
System of Records Number (Ex. 09–25–
0223), by any of the following methods:
• Federal eRulemaking Portal: https://
regulations.gov. Follow the instructions
for submitting comments.
• Email: plak@mail.nih.gov and
include PA SOR number (Ex. 09–25–
0223) in the subject line of the message.
• Phone: (301) 402–6201 (not a tollfree number).
• Fax: (301) 402–0169.
• Mail: NIH Privacy Act Officer,
Office of Management Assessment,
National Institutes of Health, 6011
Executive Boulevard, Suite 601, MSC
7669, Rockville, Maryland 20892.
• Hand Delivery/Courier: 6011
Executive Boulevard, Suite 601, MSC
7669, Rockville, Maryland 20892.
Comments received will be available
for inspection and copying at this same
address from 9:00 a.m. to 3:00 p.m.,
Monday through Friday, Federal
holidays excepted.
FOR FURTHER INFORMATION, CONTACT: NIH
Privacy Act Officer, Office of
Management Assessment (OMA), Office
of the Director (OD), National Institutes
of Health (NIH), 6011 Executive
Boulevard, Suite 601, MSC 7669,
Rockville, Maryland 20892, or
telephone (301) 402–6201 (not a toll-free
number).
SUPPLEMENTARY INFORMATION: NIH is
establishing the ‘‘NIH Records Related
to Research Misconduct Proceedings’’
system. The new system will be used by
NIH to ensure that research misconduct
proceedings are carried out in
accordance with the NIH Intramural
Research Program Policies and
Procedures for Research Misconduct
Proceedings (‘‘NIH Policy’’), 42 CFR Part
93, and other applicable Federal statutes
and regulations; enable NIH to inform
Institute/Center (IC), NIH, Office of
Research Integrity (ORI), Public Health
Service (PHS), and Department of
Health and Human Services (DHHS)
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
enable NIH to notify, consult with, and
provide assistance to other Federal,
State, local, or Tribal government
agencies to permit them to take action
to protect the health and safety of the
public, to promote the integrity of NIHand PHS-supported research, to
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conserve public funds, or to pursue
potential violations of civil and criminal
statutes. The system is more thoroughly
detailed below and in an associated
rulemaking document that outlines the
exemptions proposed for the system and
the reasons for exempting the system
from certain provisions of the Privacy
Act.
Dated: June 29, 2012.
Colleen Barros,
Deputy Director for Management, National
Institutes of Health.
SYSTEM NUMBER:
09–25–0223
SYSTEM NAME:
NIH Records Related to Research
Misconduct Proceedings, HHS/NIH
SECURITY CLASSIFICATION:
Unclassified
SYSTEM LOCATION:
This system of records will be located
in National Institutes of Health (NIH)
facilities and/or in the facilities of
contractors and/or other affiliates
working on behalf of NIH. Specific
location:
Office of Intramural Research (OIR),
National Institutes of Health (NIH), 9000
Rockville Pike, Bethesda, Maryland
20892.
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CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The system will contain records about
individuals who are the subject of
research misconduct allegations or
proceedings, referred to as
‘‘respondents.’’ The Public Health
Service (PHS) Policies on Research
Misconduct (‘‘PHS Policies on Research
Misconduct’’), 42 CFR Part 93 (‘‘Part
93’’), define 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. This definition has also
been incorporated into the NIH
Intramural Research Program Policies &
Procedures for Research Misconduct
Proceedings (‘‘NIH Policy’’). Other
individuals who may be involved in
research misconduct allegations or
proceedings (e.g., complainants,
witnesses) are not record subjects for
purposes of this system.
Consistent with the NIH’s
responsibilities under Part 93 and the
NIH Policy, this system notice applies to
alleged or actual research misconduct
(fabrication, falsification, or plagiarism
in proposing, performing, or reviewing
research, or in reporting research
results) involving research: (1) Carried
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out in NIH facilities by any person; (2)
funded by the NIH Intramural Research
Program (IRP) in any location; or (3)
undertaken by an NIH employee or
trainee as part of his or her official NIH
duties or NIH training activities,
regardless of location. A person who, at
the time of the alleged or actual research
misconduct, was employed by, was an
agent of, or was affiliated by contract,
agreement, or other arrangement with
NIH, is subject to the NIH Policy and
covered by this system if, for example,
he or she is involved in: (1) NIH- or
PHS-supported biomedical or
behavioral research; (2) NIH- or PHSsupported biomedical or behavioral
research training programs; (3) NIH- or
PHS-supported activities that are related
to biomedical or behavioral research or
research training, such as the operation
of tissue and data banks and the
dissemination of research information;
(4) plagiarism of research records
produced in the course of NIH- or PHSsupported research, research training or
activities related to that research or
research training; or (5) an application
or proposal for NIH or PHS support for
biomedical or behavioral 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 (regardless of whether it is
approved or funded).
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 in Part 93 and
the NIH Policy to mean ‘‘any actions
related to alleged research misconduct,’’
including, but not limited to, allegation
assessments, inquiries, investigations,
oversight reviews by the Office of
Research Integrity (ORI) of the U.S.
Department of Health and Human
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Services (DHHS, HHS or Department),
hearings, and administrative appeals.
The records include all information
that NIH receives or generates in
overseeing or conducting research
misconduct proceedings, including the
implementation of research misconduct
findings, and all information that NIH
submits to, or receives from, ORI or
other institutions under Part 93. 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 NIH or PHS funding involved,
including grant numbers; the offices,
Institutes, Centers, and officials
responsible for conducting the actions
that are part of the research misconduct
proceeding; the documentation used in
the assessment, 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 reports; and records of
findings, administrative actions, and
appeal proceedings, if any.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The legal authorities to operate and
maintain this Privacy Act records
system are Sections 301, 401, 402, and
405 of the Public Health Service Act (42
U.S.C. 241, 281, 282, and 284); 5 U.S.C.
301; 44 U.S.C. 3101; and 42 CFR part 93.
PURPOSE(S):
NIH personnel and any contractors
assisting them will use information from
this system, on a need-to-know basis, for
the following purposes:
1. To enable NIH and its Institutes
and Centers (‘‘ICs’’) to protect the health
and safety of the public, to promote the
integrity of NIH- or PHS-supported
research, and to conserve public funds;
2. To enable NIH to discharge
effectively its responsibilities in
managing the NIH intramural research
program and in the award and
administration of research and training
grants, cooperative agreements, and
contracts;
3. To ensure that research misconduct
proceedings are carried out in
accordance with the NIH Policy, 42 CFR
Part 93, and other applicable Federal
statutes and regulations;
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4. To enable NIH to inform other IC,
NIH, ORI, PHS, and other HHS 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. To enable NIH to notify, consult
with, and provide assistance to other
Federal, State, local, or Tribal
governmental agencies to permit them
to take action to protect the health and
safety of the public, to promote the
integrity of NIH- and PHS-supported
research, to conserve public funds, or to
pursue potential violations of civil and
criminal statutes.
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ROUTINE USES DISCLOSURES MADE OUTSIDE OF
THE DEPARTMENT OF HEALTH AND HUMAN
SERVICES (HHS OR DEPARTMENT) OF RECORDS
MAINTAINED IN THE SYSTEM, INCLUDING
CATEGORIES OF USERS AND THE PURPOSES OF
SUCH USES:
A ‘‘routine use’’ is defined in 45 CRF
5b.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 which
NIH will disclose information from this
system of records are as follows:
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. Recipients of
disclosures under this routine use may
include: Experts asked to perform
statistical, forensic or other analyses or
otherwise to provide assistance;
institutions with which the
respondent(s) was previously or is
currently affiliated; Federal, State, local,
and Tribal governmental agencies; the
respondent(s); the complainant(s);
witnesses; and organizations or
individuals acting on behalf of those
institutions, agencies, and individuals;
provided, however, in each case NIH
determines whether limited disclosures,
confidentiality statements, contractual
commitments to comply with the
requirements of the Privacy Act of 1974,
or similar measures 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 NIH/
DHHS guest researchers, special
government employees (SGEs), trainees,
volunteers, former employees,
contractors, and other persons engaged
to perform a service in support of NIH/
DHHS related to this system of records,
if such persons need access to the
records to perform their assigned task;
provided, however, in each case NIH/
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DHHS determines whether limited
disclosures, confidentiality statements,
contractual commitments to comply
with the requirements of the Privacy Act
of 1974, or similar measures 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 NIH/DHHS determines that the
disclosure is for a purpose compatible
with the purpose for which the agency
collected the records.
3. Disclosure may be made to other
Federal, State, local, or Tribal
governmental agencies and offices, if
NIH has reason to believe that a research
misconduct proceeding may involve
that agency or office.
4. 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
governmental agency, whether Federal,
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.
5. Disclosure may be made to
Institutional Review Boards, researchsponsoring institutions, and individual
research subjects, regarding information
obtained or developed through a
research misconduct proceeding that, in
NIH’s judgment, may have implications
for individuals’ health or for their
participation in a research study.
6. After NIH makes a finding of
research misconduct and has informed
ORI of the finding, disclosure may be
made to responsible officials of NIH- or
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 NIH, ORI, or HHS makes a finding
or takes an action potentially affecting
the institution or organization or its NIH
or PHS support for research, research
training, or related activities.
7. A record from this system may be
disclosed to a Federal, State, local, or
Tribal governmental agency maintaining
civil, criminal, or other relevant
enforcement records, or other pertinent
records, or to another public authority
or professional organization, if
necessary to obtain information relevant
to an investigation concerning the
employment, clearance, suitability,
eligibility or retention of an employee or
other personnel action, the retention of
a security clearance, the letting of a
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contract, issuance of a benefit or
qualification decision made by HHS or
NIH. No disclosure will be made unless
the information has been determined to
be sufficiently reliable to support a
referral to another office within the
agency or to another Federal agency for
criminal, civil, administrative,
personnel, or regulatory action. The
other agency or licensing organization
may then make a request supported by
the written consent of the individual for
the entire record if it so chooses. No
information will be released that would
reveal a confidential source.
8. After NIH makes a finding of
research misconduct and has informed
ORI of the finding, disclosure may be
made to research collaborators of the
respondent, professional journals, other
publications, news media, professional
societies, 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, unless NIH
determines that release of the specific
information in the context of a
particular case would constitute a
clearly unwarranted invasion of
personal privacy. No information will
be released that would reveal a
confidential source.
9. After NIH makes a finding of
research misconduct and has informed
ORI of the finding, disclosure may be
made to a State or other professional
licensing board, certifying body, or
other similar entity authorized to
conduct 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.
10. After NIH concludes a research
misconduct proceeding without a
finding of research misconduct or a
settlement, disclosure may be made to
the respondent, the complainant,
witnesses, or other persons involved in
or aware of the research misconduct
proceeding; provided, however, in each
case NIH determines whether limited
disclosures, confidentiality statements,
contractual commitments to comply
with the requirements of the Privacy Act
of 1974, or similar measures 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 the
Department of Justice (DOJ), a court, or
other tribunal, when: (a) The agency or
any component thereof; (b) any
employee of the agency in his or her
official capacity; (c) any employee of the
agency in his or her individual capacity
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where the DOJ has agreed to represent
the employee; or (d) the United States
Government, is a party to litigation or
has an interest in such litigation and, by
careful review, the agency determines
that the records are both relevant and
necessary to the litigation and the use of
such records by the DOJ, a court, or
other tribunal 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. 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, if the information
disclosed is relevant and necessary for
that assistance.
13. Disclosure may be made to a
congressional office from the record of
an individual in response to an inquiry
from the congressional office made
pursuant to the written request of the
individual and if disclosure does not
compromise the law enforcement
activities of the Office of Research
Integrity or other government agency.
14. NIH may disclose information to
the National Archives and Records
Administration (NARA), General
Services Administration (GSA), or other
Federal government agencies pursuant
to records management inspections
conducted under the authority of 44
U.S.C. 2904 and 2906.
15. Records may become accessible to
U.S. Department of Homeland Security
(DHS) cyber security personnel, if
captured in an intrusion detection
system used by HHS and DHS pursuant
to the Einstein 2 program. Under
Einstein 2, DHS uses intrusion detection
systems to monitor Internet traffic to
and from federal computer networks to
prevent malicious computer code from
reaching the networks. According to
DHS’ Privacy Impact Assessment for
Einstein 2 (available on the DHS
Cybersecurity privacy Web site, https://
www.dhs.gov/files/publications/
editorial_0514.shtm#4), only personally
identifiable information (PII) that is
directly related to a malicious code
security incident is captured by and
accessible to DHS, and DHS does not
access PII unless the PII is part of the
malicious code.
NIH may also disclose information
from this system as authorized directly
in the Privacy Act at 5 U.S.C. 552a(b).
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POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records will be stored in various
electronic media and paper form, and
maintained under secure conditions in
limited access areas or with controlled
access. Only authorized users whose
official duties require the use of this
information will have regular access to
the records in this system.
In accordance with established NIH,
HHS and other Federal security policies
and controls, records may also be
located, maintained and accessed from
secure servers whenever feasible or
located on portable/mobile devices
including, but not limited to: Laptops,
PDAs, USB drives, portable hard drives,
Blackberrys, iPods, CDs, DVDs,
electronic readers, and/or other
portable/mobile storage devices.
Records are maintained on portable/
mobile storage devices only for valid,
business purposes, with prior approval,
and in accordance with all applicable
NIH, HHS and Federal security
requirements, policies and controls.
RETRIEVABILITY:
Records will be retrieved by manual
or computer search using a unique case
number or 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:
Measures to prevent unauthorized
disclosures are implemented as
appropriate for each location or form of
storage and for the types of records
maintained. Site(s) implement
personnel and procedural safeguards
such as the following:
Authorized Users:
Access is strictly limited to ensure
least privilege by authorized personnel
whose duties require such access (i.e.,
valid, business need-to-know). Records
from this system are available to the
System Manager, to the Director, NIH,
and to other appropriate NIH staff when
they have a need for the records in the
performance of their duties. Records are
also available to the Director, ORI, and
to other appropriate HHS officials,
including attorneys in the Office of the
General Counsel, 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.
Physical Safeguards:
Controls to secure the data and
protect paper and electronic records,
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buildings, and related infrastructure
against threats associated with their
physical environment include, but are
not limited to the use of the HHS
Employee ID and/or badge number and
NIH key cards and security guards.
Paper records are secured in locked file
cabinets, offices and facilities.
Electronic media are kept on secure
servers or computer systems. Data on
computer files is accessed by a
password known only to authorized
users who have a need for the data in
the performance of their duties as
determined by the System Manager.
During regular business hours, rooms in
this restricted area are unlocked but
entry is controlled by on-site personnel.
Security guards perform random checks
on the physical security of the storage
locations after duty hours, including
weekends and holidays. The NIH main
campus in Bethesda, Maryland is
protected by perimeter barriers and
limited points of access, security
personnel, and intrusion alarms.
Electronic 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. Individually
identifiable records are kept in locked
file cabinets or in rooms under the
direct control of the System Manager.
Contractor interaction with records
covered by this system will occur onsite and no physical records (paper or
electronic) will be allowed to be
removed from the NIH Office of
Intramural Research unless authorized.
All authorized users of personal
information in connection with the
performance of their jobs protect
information from public view and from
unauthorized personnel entering an
unsupervised area/office.
Administrative Safeguards:
Controls to ensure proper protection
of information and information
technology systems include, but are not
limited to the completion of a
Certification and Accreditation (C&A)
package and a Privacy Impact
Assessment (PIA) for associated
information technology systems, a
system security plan, a contingency or
back-up plan, user manuals, and
mandatory completion of annual NIH
Information Security and Privacy
Awareness training. All authorized
users of personal information in
connection with the performance of
their jobs (see Authorized Users, above)
protect information from public view
and from unauthorized personnel
entering an unsupervised area/office.
When the design, development, or
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Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Notices
operation of a system of records on
individuals is required to accomplish an
agency function, the applicable Privacy
Act Federal Acquisition Regulation
(FAR) clauses are inserted in
solicitations and contracts.
Technical Safeguards:
Controls are generally executed by the
computer system and are employed to
minimize the possibility of
unauthorized access, use, or
dissemination of the data in the system.
They include, but are not limited to user
identification, password protection,
firewalls, virtual private network,
encryption, intrusion detection system,
common access cards, smart cards,
biometrics and public key
infrastructure.
Implementation Guidelines: This
Privacy Act System of Records Notice
conforms to and complies with Office of
Management and Budget (OMB)
Circular A–130—Appendix I ‘‘Federal
Agency Responsibilities for Maintaining
Records about Individuals’’ https://
www.whitehouse.gov/omb/assets/omb/
circulars/a130/a130trans4.pdf,
standards outlined in the Health and
Human Services (HHS) General
Administration Manual (GAM), HHS
Chapter 45–10 ‘‘Privacy Act—Basic
Requirements and Relationships’’
https://www.hhs.gov/hhsmanuals/gam/
chapters/45–10.pdf, HHS Chapter 45–12
‘‘Creation, Alteration, and Termination
of Privacy Act Systems of Records and
Associated Documentation’’ (available
in paper copy only), HHS Chapter 45–
13, ‘‘Safeguarding Records Contained in
Systems of Records’’ https://
www.hhs.gov/hhsmanuals/gam/
chapters/45–13.pdf, and HHS
Information Security and Privacy
Program Policy.
Alleged or Confirmed Security
Incidents: NIH will report and take
action to remediate security incidents
involving the disclosure of personally
identifiable information according to
law, regulations, OMB guidance, HHS
and NIH policies.
srobinson on DSK4SPTVN1PROD with NOTICES
RETENTION AND DISPOSAL:
Records will be maintained for 7 years
in accordance with 42 CFR Part 93 and
retained and disposed of under the
authority of the NIH Records Control
Schedule contained in Manual Chapter
1743, ‘‘Keeping and Destroying
Records’’, Appendix 1, item 1700–A–3.
Refer to the NIH Manual Chapter for
specific retention and disposition
instructions: https://www1.od.nih.gov/
oma/manualchapters/management/
1743.
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SYSTEM MANAGER AND ADDRESS:
The agency official responsible for the
system policies and practices outlined
above is:
NIH Agency Intramural Research
Integrity Officer (AIRIO), Office of
Intramural Research (OIR), National
Institutes of Health (NIH), 9000
Rockville Pike, Bethesda, Maryland
20892.
NOTIFICATION PROCEDURE:
This system will be exempt from the
Privacy Act provision requiring
procedures for notifying an individual,
upon his or her request, if the system
contains a record about him or her.
However, consideration will be given to
requests addressed to the System
Manager listed above. Any individual
who wishes to know if this system
contains a record about him or her may
make a written request to the System
Manager.
RECORD ACCESS PROCEDURE:
This system will be exempt from
access. However, because the access
exemption is limited and discretionary,
consideration will be given to access
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 he or she is who he or
she claims to be and understands that
the knowing and willful request of a
record pertaining to an individual under
false pretenses is a criminal offense
under the Privacy Act, subject to a fine
of up to five thousand dollars. If records
are requested on behalf of a minor or
legally incapacitated person, a statement
of guardianship/conservatorship must
be included. Requesters should also
reasonably specify the record contents
being sought. Requests should include
(a) full name, (b) address, (c) the
approximate date(s) the information was
collected, (d) the types of information
collected, and (e) the office or official
responsible for the collection of
information, etc. Individuals may also
request an accounting of disclosures
that have been made of their records, if
any, if the System Manager determines
that disclosure would not compromise
the law enforcement activities of the
NIH Office of Intramural Research.
(These access procedures are in
accordance with Department regulation
(45 CFR 5b.5(a)(2)).
52047
address specified above, and reasonably
identify the record and specify the
information to be contested, the
corrective action sought, and the
reason(s) for requesting the correction,
along with supporting information. The
right to contest records is limited to
information which is factually
inaccurate, incomplete, irrelevant, or
untimely (obsolete).
RECORD SOURCE CATEGORIES:
Information in this system is received
or obtained from many sources,
including: (1) Directly from the
complainant or respondent or his/her
representative; (2) derived from
materials supplied by the complainant
or respondent or his/her representative;
(3) from information supplied by
institutions, witnesses, scientific
publications or other nongovernmental
sources; (4) from observation and
analysis made by NIH staff, guest
researchers, SGEs, trainees, volunteers,
former employees, contractors, and
other persons engaged to perform a
service in support of NIH; (5)
departmental and other Federal, State,
local, and Tribal government records;
(6) from hearings and other
administrative proceedings; and (7)
from any other relevant source.
EXEMPTIONS CLAIMED FOR THIS SYSTEM:
Pursuant to 5 U.S.C. 552a (k)(2) and
(k)(5) of the Privacy Act, the system will
be exempted from the Privacy Act
requirements pertaining to providing an
accounting of disclosures, access and
amendment, notification, and agency
procedures and rules (5 U.S.C. 552a
(c)(3), (d)(1)–(4), (e)(4)(G)–(H), and (f)).
NIH believes that these exemptions are
necessary to maintain the integrity of
the research misconduct proceedings
and to ensure that the NIH’s efforts to
obtain accurate and objective
information will not be hindered.
However, any individual who has been
denied any right, privilege, or benefit to
which he or she otherwise would have
been entitled as a result of the
maintenance of such material will be
given access to the material, unless
disclosure of the material would reveal
the identity of a source who furnished
information to the Government under an
express promise of confidentiality.
CONTESTING RECORD PROCEDURE (REDRESS):
[FR Doc. 2012–20884 Filed 8–27–12; 8:45 am]
This system will be exempt from
redress. However, records that contain
factually incorrect information may be
amended. To contest such information,
write to the System Manager at the
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Agencies
[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Pages 52043-52047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20884]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Privacy Act of 1974; Proposed Exempt New System of Records
AGENCY: National Institutes of Health (NIH), Department of Health and
Human Services (DHHS).
ACTION: Notification of a proposed exempt new system of records.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, as amended (Privacy Act), the National Institutes of Health (NIH)
is proposing to establish an exempt new system of records, 09-25-0223,
``NIH Records Related to Research Misconduct Proceedings, HHS/NIH.''
The new system will contain records pertaining to individual
respondents who are the subject of research misconduct allegations or
proceedings governed by the Public Health Service (PHS) Policies on
Research Misconduct (``PHS Policies on Research Misconduct''), 42 CFR
Part 93 (``Part 93''). Because this is a law enforcement investigatory
system, NIH has published a Notice of Proposed Rulemaking to exempt the
system from certain requirements of the Privacy Act; specifically, the
provisions pertaining to providing an accounting of disclosures, access
and amendment, notification, and agency procedures and rules.
DATES: The new system of records will be effective on the date of
publication of this notice, with the exception of the routine uses and
the requested exemptions. The routine uses will become effective on
October 12, 2012. As detailed in the related rulemaking notices
published elsewhere in the Federal Register, unless revised or
withdrawn in response to comments, the requested exemptions will become
effective 135 days after publication of the rulemaking notices. Submit
either electronic or written comments regarding this notice by October
12, 2012. The NIH has sent a Report of the Proposed Exempt New System
to the Congress and to the Office of Management and Budget (OMB).
ADDRESSEES: You may submit comments, identified by the Privacy Act
System of Records Number (Ex. 09-25-0223), by any of the following
methods:
Federal eRulemaking Portal: https://regulations.gov. Follow
the instructions for submitting comments.
Email: plak@mail.nih.gov and include PA SOR number (Ex.
09-25-0223) in the subject line of the message.
Phone: (301) 402-6201 (not a toll-free number).
Fax: (301) 402-0169.
Mail: NIH Privacy Act Officer, Office of Management
Assessment, National Institutes of Health, 6011 Executive Boulevard,
Suite 601, MSC 7669, Rockville, Maryland 20892.
Hand Delivery/Courier: 6011 Executive Boulevard, Suite
601, MSC 7669, Rockville, Maryland 20892.
Comments received will be available for inspection and copying at
this same address from 9:00 a.m. to 3:00 p.m., Monday through Friday,
Federal holidays excepted.
FOR FURTHER INFORMATION, CONTACT: NIH Privacy Act Officer, Office of
Management Assessment (OMA), Office of the Director (OD), National
Institutes of Health (NIH), 6011 Executive Boulevard, Suite 601, MSC
7669, Rockville, Maryland 20892, or telephone (301) 402-6201 (not a
toll-free number).
SUPPLEMENTARY INFORMATION: NIH is establishing the ``NIH Records
Related to Research Misconduct Proceedings'' system. The new system
will be used by NIH to ensure that research misconduct proceedings are
carried out in accordance with the NIH Intramural Research Program
Policies and Procedures for Research Misconduct Proceedings (``NIH
Policy''), 42 CFR Part 93, and other applicable Federal statutes and
regulations; enable NIH to inform Institute/Center (IC), NIH, Office of
Research Integrity (ORI), Public Health Service (PHS), and Department
of Health and Human Services (DHHS) 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 enable NIH to notify,
consult with, and provide assistance to other Federal, State, local, or
Tribal government agencies to permit them to take action to protect the
health and safety of the public, to promote the integrity of NIH- and
PHS-supported research, to
[[Page 52044]]
conserve public funds, or to pursue potential violations of civil and
criminal statutes. The system is more thoroughly detailed below and in
an associated rulemaking document that outlines the exemptions proposed
for the system and the reasons for exempting the system from certain
provisions of the Privacy Act.
Dated: June 29, 2012.
Colleen Barros,
Deputy Director for Management, National Institutes of Health.
SYSTEM NUMBER:
09-25-0223
SYSTEM NAME:
NIH Records Related to Research Misconduct Proceedings, HHS/NIH
SECURITY CLASSIFICATION:
Unclassified
SYSTEM LOCATION:
This system of records will be located in National Institutes of
Health (NIH) facilities and/or in the facilities of contractors and/or
other affiliates working on behalf of NIH. Specific location:
Office of Intramural Research (OIR), National Institutes of Health
(NIH), 9000 Rockville Pike, Bethesda, Maryland 20892.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The system will contain records about individuals who are the
subject of research misconduct allegations or proceedings, referred to
as ``respondents.'' The Public Health Service (PHS) Policies on
Research Misconduct (``PHS Policies on Research Misconduct''), 42 CFR
Part 93 (``Part 93''), define 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. This definition has also been incorporated into the NIH
Intramural Research Program Policies & Procedures for Research
Misconduct Proceedings (``NIH Policy''). Other individuals who may be
involved in research misconduct allegations or proceedings (e.g.,
complainants, witnesses) are not record subjects for purposes of this
system.
Consistent with the NIH's responsibilities under Part 93 and the
NIH Policy, this system notice applies to alleged or actual research
misconduct (fabrication, falsification, or plagiarism in proposing,
performing, or reviewing research, or in reporting research results)
involving research: (1) Carried out in NIH facilities by any person;
(2) funded by the NIH Intramural Research Program (IRP) in any
location; or (3) undertaken by an NIH employee or trainee as part of
his or her official NIH duties or NIH training activities, regardless
of location. A person who, at the time of the alleged or actual
research misconduct, was employed by, was an agent of, or was
affiliated by contract, agreement, or other arrangement with NIH, is
subject to the NIH Policy and covered by this system if, for example,
he or she is involved in: (1) NIH- or PHS-supported biomedical or
behavioral research; (2) NIH- or PHS-supported biomedical or behavioral
research training programs; (3) NIH- or PHS-supported activities that
are related to biomedical or behavioral research or research training,
such as the operation of tissue and data banks and the dissemination of
research information; (4) plagiarism of research records produced in
the course of NIH- or PHS-supported research, research training or
activities related to that research or research training; or (5) an
application or proposal for NIH or PHS support for biomedical or
behavioral 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 (regardless of
whether it is approved or funded).
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 in
Part 93 and the NIH Policy to mean ``any actions related to alleged
research misconduct,'' including, but not limited to, allegation
assessments, inquiries, investigations, oversight reviews by the Office
of Research Integrity (ORI) of the U.S. Department of Health and Human
Services (DHHS, HHS or Department), hearings, and administrative
appeals.
The records include all information that NIH receives or generates
in overseeing or conducting research misconduct proceedings, including
the implementation of research misconduct findings, and all information
that NIH submits to, or receives from, ORI or other institutions under
Part 93. 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 NIH or PHS funding involved, including grant numbers; the offices,
Institutes, Centers, and officials responsible for conducting the
actions that are part of the research misconduct proceeding; the
documentation used in the assessment, 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 reports; and records of
findings, administrative actions, and appeal proceedings, if any.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The legal authorities to operate and maintain this Privacy Act
records system are Sections 301, 401, 402, and 405 of the Public Health
Service Act (42 U.S.C. 241, 281, 282, and 284); 5 U.S.C. 301; 44 U.S.C.
3101; and 42 CFR part 93.
PURPOSE(S):
NIH personnel and any contractors assisting them will use
information from this system, on a need-to-know basis, for the
following purposes:
1. To enable NIH and its Institutes and Centers (``ICs'') to
protect the health and safety of the public, to promote the integrity
of NIH- or PHS-supported research, and to conserve public funds;
2. To enable NIH to discharge effectively its responsibilities in
managing the NIH intramural research program and in the award and
administration of research and training grants, cooperative agreements,
and contracts;
3. To ensure that research misconduct proceedings are carried out
in accordance with the NIH Policy, 42 CFR Part 93, and other applicable
Federal statutes and regulations;
[[Page 52045]]
4. To enable NIH to inform other IC, NIH, ORI, PHS, and other HHS
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. To enable NIH to notify, consult with, and provide assistance to
other Federal, State, local, or Tribal governmental agencies to permit
them to take action to protect the health and safety of the public, to
promote the integrity of NIH- and PHS-supported research, to conserve
public funds, or to pursue potential violations of civil and criminal
statutes.
ROUTINE USES DISCLOSURES MADE OUTSIDE OF THE DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS OR DEPARTMENT) OF RECORDS MAINTAINED IN THE SYSTEM,
INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:
A ``routine use'' is defined in 45 CRF 5b.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
which NIH will disclose information from this system of records are as
follows:
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. Recipients of disclosures under this
routine use may include: Experts asked to perform statistical, forensic
or other analyses or otherwise to provide assistance; institutions with
which the respondent(s) was previously or is currently affiliated;
Federal, State, local, and Tribal governmental agencies; the
respondent(s); the complainant(s); witnesses; and organizations or
individuals acting on behalf of those institutions, agencies, and
individuals; provided, however, in each case NIH determines whether
limited disclosures, confidentiality statements, contractual
commitments to comply with the requirements of the Privacy Act of 1974,
or similar measures 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 NIH/DHHS guest researchers, special
government employees (SGEs), trainees, volunteers, former employees,
contractors, and other persons engaged to perform a service in support
of NIH/DHHS related to this system of records, if such persons need
access to the records to perform their assigned task; provided,
however, in each case NIH/DHHS determines whether limited disclosures,
confidentiality statements, contractual commitments to comply with the
requirements of the Privacy Act of 1974, or similar measures 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 NIH/DHHS determines that the disclosure is for a purpose
compatible with the purpose for which the agency collected the records.
3. Disclosure may be made to other Federal, State, local, or Tribal
governmental agencies and offices, if NIH has reason to believe that a
research misconduct proceeding may involve that agency or office.
4. 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 governmental agency, whether Federal, 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.
5. Disclosure may be made to Institutional Review Boards, research-
sponsoring institutions, and individual research subjects, regarding
information obtained or developed through a research misconduct
proceeding that, in NIH's judgment, may have implications for
individuals' health or for their participation in a research study.
6. After NIH makes a finding of research misconduct and has
informed ORI of the finding, disclosure may be made to responsible
officials of NIH- or 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 NIH, ORI, or HHS makes a finding
or takes an action potentially affecting the institution or
organization or its NIH or PHS support for research, research training,
or related activities.
7. A record from this system may be disclosed to a Federal, State,
local, or Tribal governmental agency maintaining civil, criminal, or
other relevant enforcement records, or other pertinent records, or to
another public authority or professional organization, if necessary to
obtain information relevant to an investigation concerning the
employment, clearance, suitability, eligibility or retention of an
employee or other personnel action, the retention of a security
clearance, the letting of a contract, issuance of a benefit or
qualification decision made by HHS or NIH. No disclosure will be made
unless the information has been determined to be sufficiently reliable
to support a referral to another office within the agency or to another
Federal agency for criminal, civil, administrative, personnel, or
regulatory action. The other agency or licensing organization may then
make a request supported by the written consent of the individual for
the entire record if it so chooses. No information will be released
that would reveal a confidential source.
8. After NIH makes a finding of research misconduct and has
informed ORI of the finding, disclosure may be made to research
collaborators of the respondent, professional journals, other
publications, news media, professional societies, 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, unless NIH determines that
release of the specific information in the context of a particular case
would constitute a clearly unwarranted invasion of personal privacy. No
information will be released that would reveal a confidential source.
9. After NIH makes a finding of research misconduct and has
informed ORI of the finding, disclosure may be made to a State or other
professional licensing board, certifying body, or other similar entity
authorized to conduct 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.
10. After NIH concludes a research misconduct proceeding without a
finding of research misconduct or a settlement, disclosure may be made
to the respondent, the complainant, witnesses, or other persons
involved in or aware of the research misconduct proceeding; provided,
however, in each case NIH determines whether limited disclosures,
confidentiality statements, contractual commitments to comply with the
requirements of the Privacy Act of 1974, or similar measures 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 the Department of Justice (DOJ), a
court, or other tribunal, when: (a) The agency or any component
thereof; (b) any employee of the agency in his or her official
capacity; (c) any employee of the agency in his or her individual
capacity
[[Page 52046]]
where the DOJ has agreed to represent the employee; or (d) the United
States Government, is a party to litigation or has an interest in such
litigation and, by careful review, the agency determines that the
records are both relevant and necessary to the litigation and the use
of such records by the DOJ, a court, or other tribunal 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. 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, if the information disclosed is
relevant and necessary for that assistance.
13. Disclosure may be made to a congressional office from the
record of an individual in response to an inquiry from the
congressional office made pursuant to the written request of the
individual and if disclosure does not compromise the law enforcement
activities of the Office of Research Integrity or other government
agency.
14. NIH may disclose information to the National Archives and
Records Administration (NARA), General Services Administration (GSA),
or other Federal government agencies pursuant to records management
inspections conducted under the authority of 44 U.S.C. 2904 and 2906.
15. Records may become accessible to U.S. Department of Homeland
Security (DHS) cyber security personnel, if captured in an intrusion
detection system used by HHS and DHS pursuant to the Einstein 2
program. Under Einstein 2, DHS uses intrusion detection systems to
monitor Internet traffic to and from federal computer networks to
prevent malicious computer code from reaching the networks. According
to DHS' Privacy Impact Assessment for Einstein 2 (available on the DHS
Cybersecurity privacy Web site, https://www.dhs.gov/files/publications/editorial_0514.shtm#4), only personally identifiable information (PII)
that is directly related to a malicious code security incident is
captured by and accessible to DHS, and DHS does not access PII unless
the PII is part of the malicious code.
NIH may also disclose information from this system as authorized
directly in the Privacy Act at 5 U.S.C. 552a(b).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records will be stored in various electronic media and paper form,
and maintained under secure conditions in limited access areas or with
controlled access. Only authorized users whose official duties require
the use of this information will have regular access to the records in
this system.
In accordance with established NIH, HHS and other Federal security
policies and controls, records may also be located, maintained and
accessed from secure servers whenever feasible or located on portable/
mobile devices including, but not limited to: Laptops, PDAs, USB
drives, portable hard drives, Blackberrys, iPods, CDs, DVDs, electronic
readers, and/or other portable/mobile storage devices. Records are
maintained on portable/mobile storage devices only for valid, business
purposes, with prior approval, and in accordance with all applicable
NIH, HHS and Federal security requirements, policies and controls.
RETRIEVABILITY:
Records will be retrieved by manual or computer search using a
unique case number or 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:
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location or form of storage and for the types of
records maintained. Site(s) implement personnel and procedural
safeguards such as the following:
Authorized Users:
Access is strictly limited to ensure least privilege by authorized
personnel whose duties require such access (i.e., valid, business need-
to-know). Records from this system are available to the System Manager,
to the Director, NIH, and to other appropriate NIH staff when they have
a need for the records in the performance of their duties. Records are
also available to the Director, ORI, and to other appropriate HHS
officials, including attorneys in the Office of the General Counsel,
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.
Physical Safeguards:
Controls to secure the data and protect paper and electronic
records, buildings, and related infrastructure against threats
associated with their physical environment include, but are not limited
to the use of the HHS Employee ID and/or badge number and NIH key cards
and security guards. Paper records are secured in locked file cabinets,
offices and facilities. Electronic media are kept on secure servers or
computer systems. Data on computer files is accessed by a password
known only to authorized users who have a need for the data in the
performance of their duties as determined by the System Manager. During
regular business hours, rooms in this restricted area are unlocked but
entry is controlled by on-site personnel. Security guards perform
random checks on the physical security of the storage locations after
duty hours, including weekends and holidays. The NIH main campus in
Bethesda, Maryland is protected by perimeter barriers and limited
points of access, security personnel, and intrusion alarms. Electronic
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. Individually identifiable records are kept
in locked file cabinets or in rooms under the direct control of the
System Manager. Contractor interaction with records covered by this
system will occur on-site and no physical records (paper or electronic)
will be allowed to be removed from the NIH Office of Intramural
Research unless authorized. All authorized users of personal
information in connection with the performance of their jobs protect
information from public view and from unauthorized personnel entering
an unsupervised area/office.
Administrative Safeguards:
Controls to ensure proper protection of information and information
technology systems include, but are not limited to the completion of a
Certification and Accreditation (C&A) package and a Privacy Impact
Assessment (PIA) for associated information technology systems, a
system security plan, a contingency or back-up plan, user manuals, and
mandatory completion of annual NIH Information Security and Privacy
Awareness training. All authorized users of personal information in
connection with the performance of their jobs (see Authorized Users,
above) protect information from public view and from unauthorized
personnel entering an unsupervised area/office. When the design,
development, or
[[Page 52047]]
operation of a system of records on individuals is required to
accomplish an agency function, the applicable Privacy Act Federal
Acquisition Regulation (FAR) clauses are inserted in solicitations and
contracts.
Technical Safeguards:
Controls are generally executed by the computer system and are
employed to minimize the possibility of unauthorized access, use, or
dissemination of the data in the system. They include, but are not
limited to user identification, password protection, firewalls, virtual
private network, encryption, intrusion detection system, common access
cards, smart cards, biometrics and public key infrastructure.
Implementation Guidelines: This Privacy Act System of Records
Notice conforms to and complies with Office of Management and Budget
(OMB) Circular A-130--Appendix I ``Federal Agency Responsibilities for
Maintaining Records about Individuals'' https://www.whitehouse.gov/omb/assets/omb/circulars/a130/a130trans4.pdf, standards outlined in the
Health and Human Services (HHS) General Administration Manual (GAM),
HHS Chapter 45-10 ``Privacy Act--Basic Requirements and Relationships''
https://www.hhs.gov/hhsmanuals/gam/chapters/45-10.pdf, HHS Chapter 45-12
``Creation, Alteration, and Termination of Privacy Act Systems of
Records and Associated Documentation'' (available in paper copy only),
HHS Chapter 45-13, ``Safeguarding Records Contained in Systems of
Records'' https://www.hhs.gov/hhsmanuals/gam/chapters/45-13.pdf, and HHS
Information Security and Privacy Program Policy.
Alleged or Confirmed Security Incidents: NIH will report and take
action to remediate security incidents involving the disclosure of
personally identifiable information according to law, regulations, OMB
guidance, HHS and NIH policies.
RETENTION AND DISPOSAL:
Records will be maintained for 7 years in accordance with 42 CFR
Part 93 and retained and disposed of under the authority of the NIH
Records Control Schedule contained in Manual Chapter 1743, ``Keeping
and Destroying Records'', Appendix 1, item 1700-A-3. Refer to the NIH
Manual Chapter for specific retention and disposition instructions:
https://www1.od.nih.gov/oma/manualchapters/management/1743.
SYSTEM MANAGER AND ADDRESS:
The agency official responsible for the system policies and
practices outlined above is:
NIH Agency Intramural Research Integrity Officer (AIRIO), Office of
Intramural Research (OIR), National Institutes of Health (NIH), 9000
Rockville Pike, Bethesda, Maryland 20892.
NOTIFICATION PROCEDURE:
This system will be exempt from the Privacy Act provision requiring
procedures for notifying an individual, upon his or her request, if the
system contains a record about him or her. However, consideration will
be given to requests addressed to the System Manager listed above. Any
individual who wishes to know if this system contains a record about
him or her may make a written request to the System Manager.
RECORD ACCESS PROCEDURE:
This system will be exempt from access. However, because the access
exemption is limited and discretionary, consideration will be given to
access 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 he or she is who he or she
claims to be and understands that the knowing and willful request of a
record pertaining to an individual under false pretenses is a criminal
offense under the Privacy Act, subject to a fine of up to five thousand
dollars. If records are requested on behalf of a minor or legally
incapacitated person, a statement of guardianship/conservatorship must
be included. Requesters should also reasonably specify the record
contents being sought. Requests should include (a) full name, (b)
address, (c) the approximate date(s) the information was collected, (d)
the types of information collected, and (e) the office or official
responsible for the collection of information, etc. Individuals may
also request an accounting of disclosures that have been made of their
records, if any, if the System Manager determines that disclosure would
not compromise the law enforcement activities of the NIH Office of
Intramural Research. (These access procedures are in accordance with
Department regulation (45 CFR 5b.5(a)(2)).
CONTESTING RECORD PROCEDURE (REDRESS):
This system will be exempt from redress. However, records that
contain factually incorrect information may be amended. To contest such
information, write to the System Manager at the address specified
above, and reasonably identify the record and specify the information
to be contested, the corrective action sought, and the reason(s) for
requesting the correction, along with supporting information. The right
to contest records is limited to information which is factually
inaccurate, incomplete, irrelevant, or untimely (obsolete).
RECORD SOURCE CATEGORIES:
Information in this system is received or obtained from many
sources, including: (1) Directly from the complainant or respondent or
his/her representative; (2) derived from materials supplied by the
complainant or respondent or his/her representative; (3) from
information supplied by institutions, witnesses, scientific
publications or other nongovernmental sources; (4) from observation and
analysis made by NIH staff, guest researchers, SGEs, trainees,
volunteers, former employees, contractors, and other persons engaged to
perform a service in support of NIH; (5) departmental and other
Federal, State, local, and Tribal government records; (6) from hearings
and other administrative proceedings; and (7) from any other relevant
source.
EXEMPTIONS CLAIMED FOR THIS SYSTEM:
Pursuant to 5 U.S.C. 552a (k)(2) and (k)(5) of the Privacy Act, the
system will be exempted from the Privacy Act requirements pertaining to
providing an accounting of disclosures, access and amendment,
notification, and agency procedures and rules (5 U.S.C. 552a (c)(3),
(d)(1)-(4), (e)(4)(G)-(H), and (f)). NIH believes that these exemptions
are necessary to maintain the integrity of the research misconduct
proceedings and to ensure that the NIH's efforts to obtain accurate and
objective information will not be hindered. However, any individual who
has been denied any right, privilege, or benefit to which he or she
otherwise would have been entitled as a result of the maintenance of
such material will be given access to the material, unless disclosure
of the material would reveal the identity of a source who furnished
information to the Government under an express promise of
confidentiality.
[FR Doc. 2012-20884 Filed 8-27-12; 8:45 am]
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