Privacy Act of 1974; System of Records, 11213-11217 [2018-05176]
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Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
doctoral-level health psychologists to
effectively address substance use
disorder (SUD) including opioid use?
4. If your institution has received in
the past, is currently receiving, or
applied for but did not receive GPE
funding, what features or requirements
of the GPE Program were easy to
incorporate and/or beneficial in the
development and implementation of
your program, and which ones posed
challenges? Please provide specific
examples. If your institution did not
apply for GPE funding, what features or
requirements of the GPE Program posed
challenges to the development of your
program or dissuaded your institution
from applying to the program?
5. What health workforce training
strategies within the experiential
training sites could the GPE Program
address to increase access to integrated
behavioral health/primary care services
in underserved and/or rural
populations? Please provide a
description of practice.
6. Type and site including geographic
locations (e.g., large health system,
private practices, group practices,
Federally Qualified Health Center, etc.).
Dated: March 8, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018–05064 Filed 3–13–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Privacy Act of 1974; System of
Records
Office of the Secretary (OS),
Department of Health and Human
Services (HHS).
ACTION: Notice of a modified system of
records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended, HHS is altering an existing
department-wide system of records,
‘‘Records About Restricted Dataset
Requesters,’’ System Number 09–90–
1401. This system of records covers
records about individuals within and
outside HHS who request restricted
datasets and software products from
HHS (e.g., for health-related scientific
research and study purposes), when
HHS maintains the requester records in
a system from which they are retrieved
directly by an individual requester’s
name or other personal identifier. The
system of records currently covers
records maintained by three HHS
Operating Divisions. It is being altered
to include records maintained by a
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SUMMARY:
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fourth Operating Division, the National
Institutes of Health (NIH), and to
include three revised and five new
routine uses, some of which will apply
to all records in the system and some of
which will apply to only NIH’s records.
The alterations affect the System
Locations, Legal Authorities, Purposes,
Retention, System Manager, and
Routine Uses sections of the System of
Records Notice (SORN).
DATES: In accordance with 5 U.S.C.
552a(e)(4) and (11), this notice is
applicable March 14, 2018, subject to a
30-day period in which to comment on
the new and revised routine uses,
described below. Please submit any
comments by April 13, 2018.
ADDRESSES: The public should submit
written comments, by mail or email, to
Beth Kramer, HHS Privacy Act Officer,
200 Independence Avenue SW, Suite
729H, Washington, DC 20201, or
beth.kramer@hhs.gov. Comments
received will be available for review at
this location without redaction, unless
otherwise advised by the commenter. To
review comments in person, please
contact Beth Kramer at beth.kramer@
hhs.gov or (202) 690–6941.
FOR FURTHER INFORMATION CONTACT:
General questions about the system of
records should be submitted by mail,
email, or phone to Beth Kramer, HHS
Privacy Act Officer, at 200
Independence Avenue SW, Suite 729H,
Washington, DC 20201; beth.kramer@
hhs.gov or (202) 690–6941.
SUPPLEMENTARY INFORMATION: This
department-wide system of records was
established April 2015 (see 80 FR
17447) and has not been previously
revised. It covers records about
individuals within and outside HHS
who request restricted datasets and
software products from HHS, when HHS
maintains the requester records in a
system from which they are retrieved
directly by an individual requester’s
name or other personal identifier. It
currently includes records maintained
by three HHS Operating Divisions. It is
being revised to add records maintained
by a fourth Operating Division, the
National Institutes of Health (NIH),
which NIH plans to begin retrieving
directly by personal identifier, and to
include three revised and five new
routine uses, some of which will apply
to all records in the system and some of
which will apply to only NIH’s records.
The alterations made to add NIH’s
records affect the System Location,
Legal Authorities, Purposes, Retention,
System Manager, and Routine Uses
sections of the System of Records Notice
(SORN). One new purpose was added to
the ‘‘Purposes’’ section, which will
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apply to all records, not just NIH
records, stating that records may be
used to evaluate accomplishment of
HHS functions related to the purposes
of this system of records and to evaluate
performance of contractors utilized by
HHS to accomplish those functions.
Minor wording and formatting changes
have been made throughout the SORN
to conform to the SORN template
prescribed in OMB Circular A–108. The
new and revised routine uses are as
follows:
• Routine use 1 has been revised to
add ‘‘including ancillary functions, such
as compiling reports and evaluating
program effectiveness and contractor
performance.’’
• Routine use 2 has been revised to
add ‘‘including ancillary functions’’ and
to add a last sentence stating: ‘‘For
example, disclosure may be made to
qualified experts not within the
definition of HHS employees as
prescribed in HHS regulations, for
opinions as a part of the controlled data
access process.’’
• Routine use 10 has been revised to
use wording prescribed in OMB
Memorandum M–17–12 issued January
3, 2017.
• Routine uses 11 through 15 are
new. Routine use 11 is a new routine
use prescribed by OMB Memorandum
M–17–12.
‘‘Restricted’’ datasets and software
products are those that HHS makes
affirmatively available to qualified
members of the public but provides
subject to restrictions, because they
contain identifiable data and/or
anonymized data that has the potential,
when combined with other data, to
identify the particular individuals, such
as patients or providers, whose
information is represented in the data.
The datasets and products are made
available through an on-line or paperbased ordering and delivery system that
provides them to qualified requesters
electronically or by mail.
The restrictions are necessary to
protect the privacy of individuals whose
information is represented in the
datasets or software products. The
restrictions typically limit the data
requester to using the data for research,
analysis, study, and aggregate statistical
reporting; prohibit any attempt to
identify any individual or establishment
represented in the data; and require
specific security measures to safeguard
the data from unauthorized access. HHS
is required by law to impose, monitor,
and enforce the restrictions (see, for
example, provisions in the Confidential
Information Protection and Statistical
Efficiency Act of 2002 (CIPSEA), 44
U.S.C. 3501 at note). To impose and
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enforce the restrictions, it is necessary
to collect information about the data
requesters.
The altered system of records will
cover requester records retrieved by
requesters’ personal identifiers in the
following four systems or any successor
systems, but only to the extent that the
records pertain to requesters seeking
restricted datasets:
• Agency for Healthcare Research
and Quality (AHRQ) ‘‘Online
Application Ordering for Products from
the Healthcare Cost and Utilization
Project (HCUP).’’ HCUP is an online
system established in 2013; it makes
restricted databases and software
available for qualified applicants to
purchase for scientific research and
public health use. Applicants may be
researchers, patients, consumers,
practitioners, providers, policy makers,
or educators. The HCUP databases are
annual files containing anonymous
information from hospital discharge
records for inpatient care and certain
components of outpatient care. The
HCUP software tools enhance the use of
the data. The online system supports
AHRQ’s mission of promoting
improvements in health care quality.
• Centers for Medicare & Medicaid
Services (CMS) DUA tracking system. A
new data use agreement (DUA) tracking
system went into production in 2015
and replaced the previous system, ‘‘Data
Agreement & Data Shipping Tracking
System (DADSS).’’ The DUA system
tracks authorization, payment status,
shipping status, and ownership of
restricted and unrestricted data extracts
between CMS, its contractors, and other
authorized entities.
• National Institutes of Health (NIH)
‘‘Controlled Data Access Systems.’’ NIH
supports ‘‘NIH-designated data
repositories,’’ which archive and
distribute controlled-access deidentified human data and results from
scientific studies under the NIH
Genomic Data Sharing Policy.
Controlled-access data in NIHdesignated data repositories are made
available for secondary research only
after investigators have obtained
approval from NIH to use the requested
data for a particular project. The
National Center for Biotechnology
Information database of Genotypes and
Phenotypes (dbGaP) serves as a central
portal to submit, locate, and request
access to controlled-access human
genomic (e.g., GWAS, sequencing,
expression, epigenomic) data. The
dbGaP’s capacity and functionality are
extended by repositories managed by
public or private organizations through
structured partnerships (‘‘trusted
partnerships’’) established by NIH
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through a contract mechanism.
Information about investigators,
Institutional Signing Officials, and other
users of NIH-designated controlled
access repositories may be located and
viewed by approved staff using the
dbGaP or trusted partner-managed
systems. Sharing research data supports
the mission of the NIH and is essential
to facilitate the translation of research
results into knowledge, products, and
procedures that improve human health.
• Substance Abuse and Mental
Health Services Administration
(SAMHSA) ‘‘Online Application for the
Data Portal (SAMHDA).’’ This online
data portal was established in 2013 to
more efficiently make restricted datasets
from SAMHSA available to designated,
approved researchers. The Data Portal
and all applications are maintained
through the Substance Abuse and
Mental Health Data Archive (SAMHDA).
Currently, data from the Drug Abuse
Warning Network (DAWN), DAWN
Medical Examiner/Coroner component,
National Survey on Drug Use and
Health (NSDUH), and NSDUH Adult
Clinical Interview data are available
through the portal. Data recipients must
complete a web-based application
process and receive project approval
from SAMHSA’s Center for Behavioral
Health and Statistics and Quality
(CBHSQ), and can use the datasets for
statistical purposes only. No fees are
charged for the datasets. The online
portal supports SAMHSA’ s mission to
make substance use and mental disorder
information and research more
accessible.
Note that this system of records does
not include:
• Records about requesters who seek
unrestricted datasets, publications, or
other information products from an
HHS on-line or paper-based ordering
and delivery system. Unrestricted
materials are also proactively made
available to the public by HHS, but are
released without restrictions (though
some may be subject to terms or
conditions of use and require
registration for an account and payment
of a fee). Because the requests or order
forms collect minimal information about
the requester (i.e., the requester’s name,
mailing address or email address,
telephone number, or other contact or
delivery information, and payment
information if a fee is imposed) they
would be adequately covered by other
SORNs (for example, ‘‘Correspondence
Tracking Management System (CTMS)’’
SORN #09–70–3005; ‘‘Consumer
Mailing List’’ SORN #09–90–0041; and
‘‘HHS Financial Management System
Records’’ SORN #09–90–0024 if a fee is
involved), if a SORN is required (i.e., if
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the records are retrieved directly by an
individual requester’s name or other
personal identifier). Examples include
records about requesters who order
materials online from AHRQ’s
Publications Online Store &
Clearinghouse or by mail from AHRQ’s
Publications Clearinghouse, which
provide only unrestricted publications
and other information products; and
records about requesters ordering
unrestricted datasets from CMS’s DUA
tracking system, which processes orders
for both restricted and unrestricted
datasets.
• Records about data requesters that
are not retrieved directly by an
individual requester’s name or other
personal identifier. These records are
not subject to the Privacy Act and are
not required to be covered in a SORN,
even when they are associated with a
restricted dataset and include additional
information about the requester (such
as, the requester’s intended research
purpose, qualifications, signed Data Use
Agreement, and confidentiality training
certificate). An example would be
requester records that are retrieved first
by a dataset identifier and/or a
requesting entity’s name, and then by an
individual researcher’s or record
custodian’s name.
A report on the altered system of
records has been sent to OMB and
Congress in accordance with 5 U.S.C.
552a(r).
Dated: March 8, 2018.
Alfred C. Johnson,
Deputy Director for Management, National
Institutes of Health.
SYSTEM NAME AND NUMBER:
Records About Restricted Dataset
Requesters, 09–90–1401
SECURITY CLASSIFICATION:
Unclassified
SYSTEM LOCATION:
The address of each agency
component responsible for the system of
records is:
• AHRQ: HCUP Project Officer,
Center for Delivery, Organization, and
Markets, 540 Gaither Road, Rockville,
MD 20850.
• CMS: DUA tracking system,
Division of Data and Information
Dissemination, Data Development and
Services Group, Office of Enterprise
Data and Analytics, Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Mailstop: B2–29–
04, Office Location: B2–03–37,
Baltimore, MD 21244–1870.
• NIH: Office of the Director, Office of
Science Policy, Division of Scientific
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Data Sharing Policy, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20817.
• SAMHSA: SAMHDA Project
Officer, CBHSQ, 5600 Fisher’s Lane,
Rockville, MD 20857.
SYSTEM MANAGER(S):
• AHRQ: HCUP Project Officer,
Center for Delivery, Organization, and
Markets, 540 Gaither Road, Rockville,
MD 20850; Telephone: 301–427–1410;
HCUP@AHRQ.GOV.
• CMS: DUA tracking system,
Division of Data and Information
Dissemination, Data Development and
Services Group, Office of Enterprise
Data and Analytics, Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Mailstop: B2–29–
04, Office Location: B2–03–37,
Baltimore, MD 21244–1870.
• NIH: Office of the Director, Office of
Science Policy, Division of Scientific
Data Sharing Policy, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20817.
• SAMHSA: SAMHDA Project
Officer, CBHSQ, 5600 Fisher’s Lane,
Rockville, MD 20857. (‘‘SAMHDA’’
refers to Substance Abuse and Mental
Health Data Archive.)
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The following legal authorities
authorize the collection and
maintenance of these records:
• AHRQ: 42 U.S.C. 299–299a; 42
U.S.C. 299c–2.
• CMS: 5 U.S.C. 552a(e)(10); 45 CFR
164.514(e); 44 U.S.C. 3544; 42 U.S.C.
1306.
• NIH: 42 U.S.C. 217a, 241, 281, 282,
284; 48 CFR Subpart 15.3; E.O. 13478.
• SAMHDA: 42 U.S.C. 290aa(d)(l); 44
U.S.C. 3501(8)
See also: CIPSEA, codified at 44
U.S.C. 3501 note.
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PURPOSE(S) OF THE SYSTEM:
The purposes of this system of records
are to provide restricted datasets and
software products to qualified data
requesters in a timely and efficient
manner and consistent with applicable
laws, and to enable HHS to enforce data
requesters’ compliance with use and
security restrictions that apply to the
data. Relevant HHS personnel use the
records on a need-to-know basis for
those purposes; specifically:
• Contact and user registration
information is used to communicate
with the requester, enable the requester
to access requested data electronically
(for example, the requester’s email
address would be used to register the
requester to use a public access web
portal or link, and to notify the
requester when data has been delivered
electronically to his registered account),
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locate the requester (e.g., for on-site
inspections or to otherwise check
compliance with the data use
agreement), and deliver and track data
provided by mail (e.g., to document
receipt for enforcement purposes and
report lost shipments to security
personnel).
• Qualifications, planned use of the
data, confidentiality training
information, signed data use agreement,
data receipt information, on-site
inspection information, and information
about data breaches or contract
violations is used to grant the request
(consistent with data use restrictions) or
deny the request, bind the requester to
the applicable data use restrictions and
other security requirements, conduct
on-site inspections or otherwise check
the requester’s compliance with the data
use agreement, enforce the agreement if
breached, and share information about
data breaches and contract violations
with other HHS components
administering restricted dataset requests
involving the same requesters.
• Payment information is used to
collect any applicable fee. Any payment
information shared with HHS
accounting and debt collection systems
is also covered under the accounting
and debt collection systems’ SORNs and
is subject to the routine uses published
in those SORNs (see, e.g., HHS
Financial Management System Records,
SORN #09–90–0024; and Debt
Management and Collection System,
SORN #09–40–0012).
• Any of the above records could be
used to evaluate accomplishment of
HHS functions related to the purposes
of this system of records and to evaluate
performance of contractors utilized by
HHS to accomplish those functions.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
Individuals within and outside HHS
who request restricted datasets and
software products that HHS makes
proactively available to qualified
members of the public, usually for
health-related scientific research and
study purposes. Examples include
individual researchers and records
custodians, project officers, or other
representatives of entities such as
universities, government agencies, and
research organizations.
CATEGORIES OF RECORDS IN THE SYSTEM:
Categories of records include:
• Request records, containing the
requester’s name and contact
information (telephone number, mailing
address, email address), affiliated entity
(e.g., if making the request as a records
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custodian or other employee), and a
description of the dataset requested.
• Order fulfillment records,
containing user registration information
such as email address and IP address (if
the requester is provided access to the
dataset electronically through a public
access web portal or link) or mailing
information (if the dataset is mailed to
the requester on a disk or other media),
and tracking information (providing
proof of delivery).
• Data use restriction records,
containing the requester’s identification,
contact, and affiliated entity
information, qualifications, intended
use of the data (e.g., study name,
contract number), confidentiality
training documentation (e.g., a coded
number indicating the individual
completed required confidentiality
training), signed and notarized data use
agreement documents (e.g., Affidavit of
Nondisclosure; Declaration of
Nondisclosure; Confidential Data Use
and Nondisclosure Agreement
(CDUNA); Individual Designations of
Agent; DUA number and expiration
date), tracking information, and any onsite inspection information.
• Payment records (if a fee is
charged), consisting of the requester’s
credit card account name, number, and
billing address, or bank routing number
and checking account name, address,
and number.
RECORD SOURCE CATEGORIES:
Information in this system of records
is obtained directly from the individual
data requester to whom it applies, or is
derived from information supplied by
the individual or provided by HHS
officials.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
PURPOSES OF SUCH USES:
Information about an individual data
requester may be disclosed to parties
outside HHS, without the individual’s
prior, written consent, as provided in
these routine uses:
1. Disclosures may be made to federal
agencies and Department contractors
that have been engaged by HHS to assist
in accomplishment of an HHS function
relating to the purposes of this system
of records (including ancillary
functions, such as compiling reports
and evaluating program effectiveness
and contractor performance) and that
have a need to have access to the
records in order to assist HHS in
performing the activity. Any contractor
will be required to comply with the
requirements of the Privacy Act.
2. Records may be disclosed to
student volunteers, individuals working
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under a personal services contract, and
other individuals performing functions
(including ancillary functions) relating
to the purposes of this system of records
for the Department but technically not
having the status of agency employees,
if they need access to the records in
order to perform their assigned agency
functions. For example, disclosure may
be made to qualified experts not within
the definition of HHS employees as
prescribed in HHS regulations, for
opinions as a part of the controlled data
access process.
3. CMS records may be disclosed to a
CMS contractor (including but not
limited to Medicare Administrative
Contractors, fiscal intermediaries, and
carriers) that assists in the
administration of a CMS-administered
health benefits program, or to a grantee
of a CMS-administered grant program,
when disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud, waste, or abuse in such
program.
4. Records may be disclosed to
another federal agency or an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any state
or local governmental agency) that
administers federally funded programs,
or that has the authority to investigate,
potential fraud, waste or abuse in
federally funded programs, when
disclosure is deemed reasonably
necessary by HHS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy or otherwise
combat fraud, waste or abuse in such
programs.
5. 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, and whether
arising by general statute or particular
program statute, or by regulation, rule,
or order issued pursuant thereto,
disclosure may be made to the
appropriate public authority, whether
federal, foreign, state, local, tribal, or
otherwise, responsible for enforcing,
investigating or prosecuting the
violation or charged with enforcing or
implementing the statute, rule,
regulation, or order issued pursuant
thereto, if the information disclosed is
relevant to the enforcement, regulatory,
investigative, or prosecutorial
responsibility of the receiving entity.
6. Information may be disclosed to the
U.S. Department of Justice (DOJ) or to a
court or other tribunal, when:
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a. the agency or any component
thereof, or
b. any employee of the agency in his
or her official capacity, or
c. any employee of the agency in his
or her individual capacity where 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, HHS determines that the records
are both relevant and necessary to the
litigation and that, therefore, the use of
such records by the DOJ, court or other
tribunal is deemed by HHS to be
compatible with the purpose for which
the agency collected the records.
7. Records may be disclosed to a
federal, foreign, state, local, tribal, or
other public authority of the fact that
this system of records contains
information relevant to the hiring or
retention of an employee, the retention
of a security clearance, the letting of a
contract, or the issuance or retention of
a license, grant or other benefit. The
other agency or licensing organization
may then make a request supported by
the written consent of the individual for
further information if it so chooses. HHS
will not make an initial disclosure
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.
8. Information may be disclosed to a
Member of Congress or Congressional
staff member in response to a written
inquiry of the Congressional office made
at the written request of the constituent
about whom the record is maintained.
The Congressional office does not have
any greater authority to obtain records
than the individual would have if
requesting the records directly.
9. Records may be disclosed to the
U.S. Department of Homeland Security
(DHS) if captured in an intrusion
detection system used by HHS and DHS
pursuant to a DHS cybersecurity
program that monitors internet traffic to
and from federal government computer
networks to prevent a variety of types of
cybersecurity incidents.
10. Disclosures may be made to
appropriate agencies, entities, and
persons when (1) HHS suspects or has
confirmed that there has been a breach
of the system of records; (2) HHS has
determined that as a result of the
suspected or confirmed breach there is
a risk of harm to individuals, HHS
(including its information systems,
programs, and operations), the Federal
Government, or national security; and
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(3) the disclosure made to such
agencies, entities, and persons is
reasonably necessary to assist in
connection with HHS efforts to respond
to the suspected or confirmed breach or
to prevent, minimize, or remedy such
harm.
11. Disclosure may be made to
another Federal agency or Federal
entity, when HHS determines that
information from this system of records
is reasonably necessary to assist the
recipient agency or entity in (1)
responding to a suspected or confirmed
breach or (2) preventing, minimizing, or
remedying the risk of harm to
individuals, the recipient agency or
entity (including its information
systems, programs, and operations), the
Federal Government, or national
security, resulting from a suspected or
confirmed breach.
12. Disclosure of past performance
information pertaining to contractors
engaged by HHS to assist in
accomplishment of an HHS function
relating to the purposes of this system
of records may be made to a federal
agency upon request and may include
information about dataset requesters.
13. NIH dataset requester records may
be included in records disclosed to
governmental or authorized nongovernmental entities with a signed data
access agreement for system data that
includes records about individuals
requesting and receiving restricted
datasets, to use in compiling reports
(such as, on the composition of
biomedical and/or research workforce;
authors of publications attributable to
federally-funded research; information
made available through third-party
systems as permitted by applicants or
awardees for agency grants or contracts;
or grant payment information reported
to federal databases).
14. When records about a requester of
an NIH restricted dataset are related to
an award or application for award under
an NIH award program, the dataset
requester records may be disclosed to
the award applicant, principal
investigator(s), institutional officials,
trainees or others named in the
application, or institutional service
providers for purposes of application
preparation, review, or award
management, and to the public
consistent with reporting and
transparency standards and to the extent
disclosure to the public would not cause
an unwarranted invasion of personal
privacy.
15. HHS may disclose records from
this system of records to the National
Archives and Records Administration
(NARA), General Services
Administration (GSA), or other relevant
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Federal Government agencies in
connection with records management
inspections conducted under the
authority of 44 U.S.C. 2904 and 2906.
Information about a dataset requester
may also be disclosed from this system
of records to parties outside HHS
without the individual’s consent for any
of the uses authorized directly in the
Privacy Act at 5 U.S.C. 552a(b)(2) and
(b)(4)–(11).
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
Records are stored in electronic
databases and hard-copy files. CMS’s
DUA tracking system records may also
be stored on portable media.
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
Records are retrieved by the data
requester’s name, registrant/user name,
User ID Number, email address, or data
use agreement (DUA) number.
POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
Records needed to enforce data use
restrictions are retained for 20 years by
AHRQ (see DAA–0510–2013–0003–
0001), 5 years by CMS (see Nl–440–10–
04), and 3 years by NIH (see DAA–
0443–2013–0004–0004) after the
agreement is closed, and may be kept
longer if necessary for enforcement,
audit, legal, or other purposes. The
equivalent SAMHSA records will be
retained indefinitely until a disposition
schedule is approved by the National
Archives and Records Administration
(NARA). SAMHSA anticipates
proposing a 5 year retention period to
NARA. Records of payments made
electronically are transmitted securely
to a Payment Card Industry-compliant
payment gateway for processing and are
not stored. Records of payments made
by check, purchase order, or wire
transfer are disposed of once the funds
have been received. Records are
disposed of using destruction methods
prescribed by NIST SP 800–88.
daltland on DSKBBV9HB2PROD with NOTICES
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
Records are safeguarded in
accordance with applicable laws, rules
and policies, including the HHS
Information Technology Security
Program Handbook, all pertinent
National Institutes of Standards and
Technology (NIST) publications, and
OMB Circular A–130, Managing
Information as a Strategic Resource.
Records are protected from
unauthorized access through
appropriate administrative, physical,
and technical safeguards. Safeguards
conform to the HHS Information
VerDate Sep<11>2014
18:17 Mar 13, 2018
Jkt 244001
Security and Privacy Program, https://
www.hhs.gov/ocio/securityprivacy/.
The safeguards include protecting the
facilities where records are stored or
accessed with security guards, badges
and cameras, securing hard-copy
records in locked file cabinets, file
rooms or offices during off-duty hours,
limiting access to electronic databases to
authorized users based on roles and the
principle of least privilege, and twofactor authentication (user ID and
password), using a secured operating
system protected by encryption,
firewalls, and intrusion detection
systems, using an SSL connection for
secure encrypted transmissions,
requiring encryption for records stored
on removable media, and training
personnel in Privacy Act and
information security requirements.
RECORD ACCESS PROCEDURES:
An individual who wishes to know if
this system of records contains records
about him or her should submit a
written request to the relevant System
Manager at the address indicated above.
The individual must verify his or her
identity by providing either a notarized
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.
CONTESTING RECORD PROCEDURES:
An individual seeking to amend the
content of information about him or her
in this system should contact the
relevant System Manager and
reasonably identify the record, specify
the information contested, state the
corrective action sought, and provide
the reasons for the amendment, with
supporting justification.
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system of records contains records
about him or her should submit a
written request to the relevant System
Manager at the address indicated above.
The individual must verify his or her
identity by providing either a notarized
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.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
11217
HISTORY:
80 FR 17447 (April 1, 2015).
[FR Doc. 2018–05176 Filed 3–13–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Privacy Act of 1974; System of
Records Notice
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of a new system of
records.
AGENCY:
In accordance with the
Privacy Act, HHS is establishing a new
system of records to be maintained by
HRSA System No. 09–15–0092 ‘‘HRSA
Trainee Information Portal (TRIP).’’ The
new system of records will cover data
about health professionals/trainees
receiving health care training supported
by Bureau of Health Workforce (BHW)
Federal awards (including, grants,
cooperative agreements, contracts,
scholarships and loans) (collectively
referred to as awards), which BHW will
use in evaluating the success of its
programs. The new system of records is
explained in the ‘‘Supplementary
Information’’ section of this notice and
fully described in the System of Records
Notice (SORN) published in this notice.
DATES: In accordance with 5 U.S.C.
552a(e)(4) and (11), this notice is
effective upon publication, subject to a
30-day period in which to comment on
the routine uses, described below.
Please submit any comments by April
13, 2018.
ADDRESSES: The public should address
written comments on the new system of
records to Director, National Center for
Health Workforce Analysis (NCHWA),
BHW, HRSA, 5600 Fishers Lane,
Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT:
General questions about the system of
records may be submitted to Director,
National Center for Health Workforce
Analysis (NCHWA), BHW, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857.
SUMMARY:
Pursuant
to the Government Performance and
Results Act (GPRA) of 1993 and the
GPRA Modernization Act of 2010, BHW
requires all recipients of Health
Professions awards to report annual
performance data to BHW to enable
BHW to determine the success of its
programs. The performance data must
include information about health
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14MRN1.SGM
14MRN1
Agencies
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11213-11217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05176]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Privacy Act of 1974; System of Records
AGENCY: Office of the Secretary (OS), Department of Health and Human
Services (HHS).
ACTION: Notice of a modified system of records.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, as amended, HHS is altering an existing department-wide system of
records, ``Records About Restricted Dataset Requesters,'' System Number
09-90-1401. This system of records covers records about individuals
within and outside HHS who request restricted datasets and software
products from HHS (e.g., for health-related scientific research and
study purposes), when HHS maintains the requester records in a system
from which they are retrieved directly by an individual requester's
name or other personal identifier. The system of records currently
covers records maintained by three HHS Operating Divisions. It is being
altered to include records maintained by a fourth Operating Division,
the National Institutes of Health (NIH), and to include three revised
and five new routine uses, some of which will apply to all records in
the system and some of which will apply to only NIH's records. The
alterations affect the System Locations, Legal Authorities, Purposes,
Retention, System Manager, and Routine Uses sections of the System of
Records Notice (SORN).
DATES: In accordance with 5 U.S.C. 552a(e)(4) and (11), this notice is
applicable March 14, 2018, subject to a 30-day period in which to
comment on the new and revised routine uses, described below. Please
submit any comments by April 13, 2018.
ADDRESSES: The public should submit written comments, by mail or email,
to Beth Kramer, HHS Privacy Act Officer, 200 Independence Avenue SW,
Suite 729H, Washington, DC 20201, or [email protected]. Comments
received will be available for review at this location without
redaction, unless otherwise advised by the commenter. To review
comments in person, please contact Beth Kramer at [email protected]
or (202) 690-6941.
FOR FURTHER INFORMATION CONTACT: General questions about the system of
records should be submitted by mail, email, or phone to Beth Kramer,
HHS Privacy Act Officer, at 200 Independence Avenue SW, Suite 729H,
Washington, DC 20201; [email protected] or (202) 690-6941.
SUPPLEMENTARY INFORMATION: This department-wide system of records was
established April 2015 (see 80 FR 17447) and has not been previously
revised. It covers records about individuals within and outside HHS who
request restricted datasets and software products from HHS, when HHS
maintains the requester records in a system from which they are
retrieved directly by an individual requester's name or other personal
identifier. It currently includes records maintained by three HHS
Operating Divisions. It is being revised to add records maintained by a
fourth Operating Division, the National Institutes of Health (NIH),
which NIH plans to begin retrieving directly by personal identifier,
and to include three revised and five new routine uses, some of which
will apply to all records in the system and some of which will apply to
only NIH's records.
The alterations made to add NIH's records affect the System
Location, Legal Authorities, Purposes, Retention, System Manager, and
Routine Uses sections of the System of Records Notice (SORN). One new
purpose was added to the ``Purposes'' section, which will apply to all
records, not just NIH records, stating that records may be used to
evaluate accomplishment of HHS functions related to the purposes of
this system of records and to evaluate performance of contractors
utilized by HHS to accomplish those functions. Minor wording and
formatting changes have been made throughout the SORN to conform to the
SORN template prescribed in OMB Circular A-108. The new and revised
routine uses are as follows:
Routine use 1 has been revised to add ``including
ancillary functions, such as compiling reports and evaluating program
effectiveness and contractor performance.''
Routine use 2 has been revised to add ``including
ancillary functions'' and to add a last sentence stating: ``For
example, disclosure may be made to qualified experts not within the
definition of HHS employees as prescribed in HHS regulations, for
opinions as a part of the controlled data access process.''
Routine use 10 has been revised to use wording prescribed
in OMB Memorandum M-17-12 issued January 3, 2017.
Routine uses 11 through 15 are new. Routine use 11 is a
new routine use prescribed by OMB Memorandum M-17-12.
``Restricted'' datasets and software products are those that HHS
makes affirmatively available to qualified members of the public but
provides subject to restrictions, because they contain identifiable
data and/or anonymized data that has the potential, when combined with
other data, to identify the particular individuals, such as patients or
providers, whose information is represented in the data. The datasets
and products are made available through an on-line or paper-based
ordering and delivery system that provides them to qualified requesters
electronically or by mail.
The restrictions are necessary to protect the privacy of
individuals whose information is represented in the datasets or
software products. The restrictions typically limit the data requester
to using the data for research, analysis, study, and aggregate
statistical reporting; prohibit any attempt to identify any individual
or establishment represented in the data; and require specific security
measures to safeguard the data from unauthorized access. HHS is
required by law to impose, monitor, and enforce the restrictions (see,
for example, provisions in the Confidential Information Protection and
Statistical Efficiency Act of 2002 (CIPSEA), 44 U.S.C. 3501 at note).
To impose and
[[Page 11214]]
enforce the restrictions, it is necessary to collect information about
the data requesters.
The altered system of records will cover requester records
retrieved by requesters' personal identifiers in the following four
systems or any successor systems, but only to the extent that the
records pertain to requesters seeking restricted datasets:
Agency for Healthcare Research and Quality (AHRQ) ``Online
Application Ordering for Products from the Healthcare Cost and
Utilization Project (HCUP).'' HCUP is an online system established in
2013; it makes restricted databases and software available for
qualified applicants to purchase for scientific research and public
health use. Applicants may be researchers, patients, consumers,
practitioners, providers, policy makers, or educators. The HCUP
databases are annual files containing anonymous information from
hospital discharge records for inpatient care and certain components of
outpatient care. The HCUP software tools enhance the use of the data.
The online system supports AHRQ's mission of promoting improvements in
health care quality.
Centers for Medicare & Medicaid Services (CMS) DUA
tracking system. A new data use agreement (DUA) tracking system went
into production in 2015 and replaced the previous system, ``Data
Agreement & Data Shipping Tracking System (DADSS).'' The DUA system
tracks authorization, payment status, shipping status, and ownership of
restricted and unrestricted data extracts between CMS, its contractors,
and other authorized entities.
National Institutes of Health (NIH) ``Controlled Data
Access Systems.'' NIH supports ``NIH-designated data repositories,''
which archive and distribute controlled-access de-identified human data
and results from scientific studies under the NIH Genomic Data Sharing
Policy. Controlled-access data in NIH-designated data repositories are
made available for secondary research only after investigators have
obtained approval from NIH to use the requested data for a particular
project. The National Center for Biotechnology Information database of
Genotypes and Phenotypes (dbGaP) serves as a central portal to submit,
locate, and request access to controlled-access human genomic (e.g.,
GWAS, sequencing, expression, epigenomic) data. The dbGaP's capacity
and functionality are extended by repositories managed by public or
private organizations through structured partnerships (``trusted
partnerships'') established by NIH through a contract mechanism.
Information about investigators, Institutional Signing Officials, and
other users of NIH-designated controlled access repositories may be
located and viewed by approved staff using the dbGaP or trusted
partner-managed systems. Sharing research data supports the mission of
the NIH and is essential to facilitate the translation of research
results into knowledge, products, and procedures that improve human
health.
Substance Abuse and Mental Health Services Administration
(SAMHSA) ``Online Application for the Data Portal (SAMHDA).'' This
online data portal was established in 2013 to more efficiently make
restricted datasets from SAMHSA available to designated, approved
researchers. The Data Portal and all applications are maintained
through the Substance Abuse and Mental Health Data Archive (SAMHDA).
Currently, data from the Drug Abuse Warning Network (DAWN), DAWN
Medical Examiner/Coroner component, National Survey on Drug Use and
Health (NSDUH), and NSDUH Adult Clinical Interview data are available
through the portal. Data recipients must complete a web-based
application process and receive project approval from SAMHSA's Center
for Behavioral Health and Statistics and Quality (CBHSQ), and can use
the datasets for statistical purposes only. No fees are charged for the
datasets. The online portal supports SAMHSA' s mission to make
substance use and mental disorder information and research more
accessible.
Note that this system of records does not include:
Records about requesters who seek unrestricted datasets,
publications, or other information products from an HHS on-line or
paper-based ordering and delivery system. Unrestricted materials are
also proactively made available to the public by HHS, but are released
without restrictions (though some may be subject to terms or conditions
of use and require registration for an account and payment of a fee).
Because the requests or order forms collect minimal information about
the requester (i.e., the requester's name, mailing address or email
address, telephone number, or other contact or delivery information,
and payment information if a fee is imposed) they would be adequately
covered by other SORNs (for example, ``Correspondence Tracking
Management System (CTMS)'' SORN #09-70-3005; ``Consumer Mailing List''
SORN #09-90-0041; and ``HHS Financial Management System Records'' SORN
#09-90-0024 if a fee is involved), if a SORN is required (i.e., if the
records are retrieved directly by an individual requester's name or
other personal identifier). Examples include records about requesters
who order materials online from AHRQ's Publications Online Store &
Clearinghouse or by mail from AHRQ's Publications Clearinghouse, which
provide only unrestricted publications and other information products;
and records about requesters ordering unrestricted datasets from CMS's
DUA tracking system, which processes orders for both restricted and
unrestricted datasets.
Records about data requesters that are not retrieved
directly by an individual requester's name or other personal
identifier. These records are not subject to the Privacy Act and are
not required to be covered in a SORN, even when they are associated
with a restricted dataset and include additional information about the
requester (such as, the requester's intended research purpose,
qualifications, signed Data Use Agreement, and confidentiality training
certificate). An example would be requester records that are retrieved
first by a dataset identifier and/or a requesting entity's name, and
then by an individual researcher's or record custodian's name.
A report on the altered system of records has been sent to OMB and
Congress in accordance with 5 U.S.C. 552a(r).
Dated: March 8, 2018.
Alfred C. Johnson,
Deputy Director for Management, National Institutes of Health.
SYSTEM NAME AND NUMBER:
Records About Restricted Dataset Requesters, 09-90-1401
SECURITY CLASSIFICATION:
Unclassified
SYSTEM LOCATION:
The address of each agency component responsible for the system of
records is:
AHRQ: HCUP Project Officer, Center for Delivery,
Organization, and Markets, 540 Gaither Road, Rockville, MD 20850.
CMS: DUA tracking system, Division of Data and Information
Dissemination, Data Development and Services Group, Office of
Enterprise Data and Analytics, Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Mailstop: B2-29-04, Office Location:
B2-03-37, Baltimore, MD 21244-1870.
NIH: Office of the Director, Office of Science Policy,
Division of Scientific
[[Page 11215]]
Data Sharing Policy, 6705 Rockledge Drive, Suite 750, Bethesda, MD
20817.
SAMHSA: SAMHDA Project Officer, CBHSQ, 5600 Fisher's Lane,
Rockville, MD 20857.
SYSTEM MANAGER(S):
AHRQ: HCUP Project Officer, Center for Delivery,
Organization, and Markets, 540 Gaither Road, Rockville, MD 20850;
Telephone: 301-427-1410; [email protected].
CMS: DUA tracking system, Division of Data and Information
Dissemination, Data Development and Services Group, Office of
Enterprise Data and Analytics, Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Mailstop: B2-29-04, Office Location:
B2-03-37, Baltimore, MD 21244-1870.
NIH: Office of the Director, Office of Science Policy,
Division of Scientific Data Sharing Policy, 6705 Rockledge Drive, Suite
750, Bethesda, MD 20817.
SAMHSA: SAMHDA Project Officer, CBHSQ, 5600 Fisher's Lane,
Rockville, MD 20857. (``SAMHDA'' refers to Substance Abuse and Mental
Health Data Archive.)
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The following legal authorities authorize the collection and
maintenance of these records:
AHRQ: 42 U.S.C. 299-299a; 42 U.S.C. 299c-2.
CMS: 5 U.S.C. 552a(e)(10); 45 CFR 164.514(e); 44 U.S.C.
3544; 42 U.S.C. 1306.
NIH: 42 U.S.C. 217a, 241, 281, 282, 284; 48 CFR Subpart
15.3; E.O. 13478.
SAMHDA: 42 U.S.C. 290aa(d)(l); 44 U.S.C. 3501(8)
See also: CIPSEA, codified at 44 U.S.C. 3501 note.
PURPOSE(S) OF THE SYSTEM:
The purposes of this system of records are to provide restricted
datasets and software products to qualified data requesters in a timely
and efficient manner and consistent with applicable laws, and to enable
HHS to enforce data requesters' compliance with use and security
restrictions that apply to the data. Relevant HHS personnel use the
records on a need-to-know basis for those purposes; specifically:
Contact and user registration information is used to
communicate with the requester, enable the requester to access
requested data electronically (for example, the requester's email
address would be used to register the requester to use a public access
web portal or link, and to notify the requester when data has been
delivered electronically to his registered account), locate the
requester (e.g., for on-site inspections or to otherwise check
compliance with the data use agreement), and deliver and track data
provided by mail (e.g., to document receipt for enforcement purposes
and report lost shipments to security personnel).
Qualifications, planned use of the data, confidentiality
training information, signed data use agreement, data receipt
information, on-site inspection information, and information about data
breaches or contract violations is used to grant the request
(consistent with data use restrictions) or deny the request, bind the
requester to the applicable data use restrictions and other security
requirements, conduct on-site inspections or otherwise check the
requester's compliance with the data use agreement, enforce the
agreement if breached, and share information about data breaches and
contract violations with other HHS components administering restricted
dataset requests involving the same requesters.
Payment information is used to collect any applicable fee.
Any payment information shared with HHS accounting and debt collection
systems is also covered under the accounting and debt collection
systems' SORNs and is subject to the routine uses published in those
SORNs (see, e.g., HHS Financial Management System Records, SORN #09-90-
0024; and Debt Management and Collection System, SORN #09-40-0012).
Any of the above records could be used to evaluate
accomplishment of HHS functions related to the purposes of this system
of records and to evaluate performance of contractors utilized by HHS
to accomplish those functions.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individuals within and outside HHS who request restricted datasets
and software products that HHS makes proactively available to qualified
members of the public, usually for health-related scientific research
and study purposes. Examples include individual researchers and records
custodians, project officers, or other representatives of entities such
as universities, government agencies, and research organizations.
CATEGORIES OF RECORDS IN THE SYSTEM:
Categories of records include:
Request records, containing the requester's name and
contact information (telephone number, mailing address, email address),
affiliated entity (e.g., if making the request as a records custodian
or other employee), and a description of the dataset requested.
Order fulfillment records, containing user registration
information such as email address and IP address (if the requester is
provided access to the dataset electronically through a public access
web portal or link) or mailing information (if the dataset is mailed to
the requester on a disk or other media), and tracking information
(providing proof of delivery).
Data use restriction records, containing the requester's
identification, contact, and affiliated entity information,
qualifications, intended use of the data (e.g., study name, contract
number), confidentiality training documentation (e.g., a coded number
indicating the individual completed required confidentiality training),
signed and notarized data use agreement documents (e.g., Affidavit of
Nondisclosure; Declaration of Nondisclosure; Confidential Data Use and
Nondisclosure Agreement (CDUNA); Individual Designations of Agent; DUA
number and expiration date), tracking information, and any on-site
inspection information.
Payment records (if a fee is charged), consisting of the
requester's credit card account name, number, and billing address, or
bank routing number and checking account name, address, and number.
RECORD SOURCE CATEGORIES:
Information in this system of records is obtained directly from the
individual data requester to whom it applies, or is derived from
information supplied by the individual or provided by HHS officials.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND PURPOSES OF SUCH USES:
Information about an individual data requester may be disclosed to
parties outside HHS, without the individual's prior, written consent,
as provided in these routine uses:
1. Disclosures may be made to federal agencies and Department
contractors that have been engaged by HHS to assist in accomplishment
of an HHS function relating to the purposes of this system of records
(including ancillary functions, such as compiling reports and
evaluating program effectiveness and contractor performance) and that
have a need to have access to the records in order to assist HHS in
performing the activity. Any contractor will be required to comply with
the requirements of the Privacy Act.
2. Records may be disclosed to student volunteers, individuals
working
[[Page 11216]]
under a personal services contract, and other individuals performing
functions (including ancillary functions) relating to the purposes of
this system of records for the Department but technically not having
the status of agency employees, if they need access to the records in
order to perform their assigned agency functions. For example,
disclosure may be made to qualified experts not within the definition
of HHS employees as prescribed in HHS regulations, for opinions as a
part of the controlled data access process.
3. CMS records may be disclosed to a CMS contractor (including but
not limited to Medicare Administrative Contractors, fiscal
intermediaries, and carriers) that assists in the administration of a
CMS-administered health benefits program, or to a grantee of a CMS-
administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud, waste, or abuse in such program.
4. Records may be disclosed to another federal agency or an
instrumentality of any governmental jurisdiction within or under the
control of the United States (including any state or local governmental
agency) that administers federally funded programs, or that has the
authority to investigate, potential fraud, waste or abuse in federally
funded programs, when disclosure is deemed reasonably necessary by HHS
to prevent, deter, discover, detect, investigate, examine, prosecute,
sue with respect to, defend against, correct, remedy or otherwise
combat fraud, waste or abuse in such programs.
5. 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, and whether arising by general
statute or particular program statute, or by regulation, rule, or order
issued pursuant thereto, disclosure may be made to the appropriate
public authority, whether federal, foreign, state, local, tribal, or
otherwise, responsible for enforcing, investigating or prosecuting the
violation or charged with enforcing or implementing the statute, rule,
regulation, or order issued pursuant thereto, if the information
disclosed is relevant to the enforcement, regulatory, investigative, or
prosecutorial responsibility of the receiving entity.
6. Information may be disclosed to the U.S. Department of Justice
(DOJ) or 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, or
c. any employee of the agency in his or her individual capacity
where 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, HHS determines that the records are both relevant
and necessary to the litigation and that, therefore, the use of such
records by the DOJ, court or other tribunal is deemed by HHS to be
compatible with the purpose for which the agency collected the records.
7. Records may be disclosed to a federal, foreign, state, local,
tribal, or other public authority of the fact that this system of
records contains information relevant to the hiring or retention of an
employee, the retention of a security clearance, the letting of a
contract, or the issuance or retention of a license, grant or other
benefit. The other agency or licensing organization may then make a
request supported by the written consent of the individual for further
information if it so chooses. HHS will not make an initial disclosure
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.
8. Information may be disclosed to a Member of Congress or
Congressional staff member in response to a written inquiry of the
Congressional office made at the written request of the constituent
about whom the record is maintained. The Congressional office does not
have any greater authority to obtain records than the individual would
have if requesting the records directly.
9. Records may be disclosed to the U.S. Department of Homeland
Security (DHS) if captured in an intrusion detection system used by HHS
and DHS pursuant to a DHS cybersecurity program that monitors internet
traffic to and from federal government computer networks to prevent a
variety of types of cybersecurity incidents.
10. Disclosures may be made to appropriate agencies, entities, and
persons when (1) HHS suspects or has confirmed that there has been a
breach of the system of records; (2) HHS has determined that as a
result of the suspected or confirmed breach there is a risk of harm to
individuals, HHS (including its information systems, programs, and
operations), the Federal Government, or national security; and (3) the
disclosure made to such agencies, entities, and persons is reasonably
necessary to assist in connection with HHS efforts to respond to the
suspected or confirmed breach or to prevent, minimize, or remedy such
harm.
11. Disclosure may be made to another Federal agency or Federal
entity, when HHS determines that information from this system of
records is reasonably necessary to assist the recipient agency or
entity in (1) responding to a suspected or confirmed breach or (2)
preventing, minimizing, or remedying the risk of harm to individuals,
the recipient agency or entity (including its information systems,
programs, and operations), the Federal Government, or national
security, resulting from a suspected or confirmed breach.
12. Disclosure of past performance information pertaining to
contractors engaged by HHS to assist in accomplishment of an HHS
function relating to the purposes of this system of records may be made
to a federal agency upon request and may include information about
dataset requesters.
13. NIH dataset requester records may be included in records
disclosed to governmental or authorized non-governmental entities with
a signed data access agreement for system data that includes records
about individuals requesting and receiving restricted datasets, to use
in compiling reports (such as, on the composition of biomedical and/or
research workforce; authors of publications attributable to federally-
funded research; information made available through third-party systems
as permitted by applicants or awardees for agency grants or contracts;
or grant payment information reported to federal databases).
14. When records about a requester of an NIH restricted dataset are
related to an award or application for award under an NIH award
program, the dataset requester records may be disclosed to the award
applicant, principal investigator(s), institutional officials, trainees
or others named in the application, or institutional service providers
for purposes of application preparation, review, or award management,
and to the public consistent with reporting and transparency standards
and to the extent disclosure to the public would not cause an
unwarranted invasion of personal privacy.
15. HHS may disclose records from this system of records to the
National Archives and Records Administration (NARA), General Services
Administration (GSA), or other relevant
[[Page 11217]]
Federal Government agencies in connection with records management
inspections conducted under the authority of 44 U.S.C. 2904 and 2906.
Information about a dataset requester may also be disclosed from
this system of records to parties outside HHS without the individual's
consent for any of the uses authorized directly in the Privacy Act at 5
U.S.C. 552a(b)(2) and (b)(4)-(11).
POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
Records are stored in electronic databases and hard-copy files.
CMS's DUA tracking system records may also be stored on portable media.
POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
Records are retrieved by the data requester's name, registrant/user
name, User ID Number, email address, or data use agreement (DUA)
number.
POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
Records needed to enforce data use restrictions are retained for 20
years by AHRQ (see DAA-0510-2013-0003-0001), 5 years by CMS (see Nl-
440-10-04), and 3 years by NIH (see DAA-0443-2013-0004-0004) after the
agreement is closed, and may be kept longer if necessary for
enforcement, audit, legal, or other purposes. The equivalent SAMHSA
records will be retained indefinitely until a disposition schedule is
approved by the National Archives and Records Administration (NARA).
SAMHSA anticipates proposing a 5 year retention period to NARA. Records
of payments made electronically are transmitted securely to a Payment
Card Industry-compliant payment gateway for processing and are not
stored. Records of payments made by check, purchase order, or wire
transfer are disposed of once the funds have been received. Records are
disposed of using destruction methods prescribed by NIST SP 800-88.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
Records are safeguarded in accordance with applicable laws, rules
and policies, including the HHS Information Technology Security Program
Handbook, all pertinent National Institutes of Standards and Technology
(NIST) publications, and OMB Circular A-130, Managing Information as a
Strategic Resource. Records are protected from unauthorized access
through appropriate administrative, physical, and technical safeguards.
Safeguards conform to the HHS Information Security and Privacy Program,
https://www.hhs.gov/ocio/securityprivacy/.
The safeguards include protecting the facilities where records are
stored or accessed with security guards, badges and cameras, securing
hard-copy records in locked file cabinets, file rooms or offices during
off-duty hours, limiting access to electronic databases to authorized
users based on roles and the principle of least privilege, and two-
factor authentication (user ID and password), using a secured operating
system protected by encryption, firewalls, and intrusion detection
systems, using an SSL connection for secure encrypted transmissions,
requiring encryption for records stored on removable media, and
training personnel in Privacy Act and information security
requirements.
RECORD ACCESS PROCEDURES:
An individual who wishes to know if this system of records contains
records about him or her should submit a written request to the
relevant System Manager at the address indicated above. The individual
must verify his or her identity by providing either a notarized 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.
CONTESTING RECORD PROCEDURES:
An individual seeking to amend the content of information about him
or her in this system should contact the relevant System Manager and
reasonably identify the record, specify the information contested,
state the corrective action sought, and provide the reasons for the
amendment, with supporting justification.
NOTIFICATION PROCEDURES:
An individual who wishes to know if this system of records contains
records about him or her should submit a written request to the
relevant System Manager at the address indicated above. The individual
must verify his or her identity by providing either a notarized 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.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
80 FR 17447 (April 1, 2015).
[FR Doc. 2018-05176 Filed 3-13-18; 8:45 am]
BILLING CODE 4140-01-P