Privacy Act of 1974; System of Records, 72481-72486 [2023-23147]
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Reserve Bank(s) indicated below and at
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1. Libertyville Savings Bank Employee
Stock Ownership Trust, Fairfield, Iowa;
to become a bank holding company by
acquiring 27.02 percent of the voting
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Board of Governors of the Federal Reserve
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Michele Taylor Fennell,
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[FR Doc. 2023–23270 Filed 10–19–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Privacy Act of 1974; System of
Records
Administration for Children
and Families, Department of Health and
Human Services.
ACTION: Notice of a modified system of
records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended, the Department of Health
and Human Services (HHS) is altering
an existing department wide system of
records, ‘‘Records About Restricted
Dataset Requesters,’’ System Number
09–90–1401, to add records maintained
by HHS’ Administration for Children
and Families (ACF) and to make other
changes, including changing the system
of records name to ‘‘Records About
Requesters of Restricted Datasets.’’ 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.
DATES: In accordance with 5 U.S.C.
552a(e)(4) and (11), this modified
system of records is effective October
20, 2023, subject to a 30-day comment
period on the revised routine use
described below. Please submit any
comments by November 20, 2023.
ADDRESSES: The public should submit
written comments, by mail or email, to
Anita Alford, Senior Official for Privacy,
Administration for Children and
Families, 330 C Street SW, Washington,
DC 20201, or anita.alford@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
General questions about the system of
records should be submitted by mail or
email to Beth Kramer, HHS Privacy Act
Officer, at 200 Independence Ave. SW—
Suite 729H, Washington, DC 20201, or
beth.kramer@hhs.gov, or (202) 690–
6941.
SUMMARY:
This
departmentwide system of records
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 record system
they are retrieved directly by an
individual requester’s name or other
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personal identifier. It currently includes
records maintained by four HHS
Operating Divisions. It is being revised
to add records maintained by a fifth
Operating Division, the Administration
for Children and Families (ACF), and to
make other changes, as explained
below:
• The system of records name has
been changed to ‘‘Records About
Requesters of Restricted Datasets.’’
• The alterations made to add ACF’s
records affect the System Location,
System Manager(s), Authorities,
Categories of Records, and Retention
sections of the System of Records Notice
(SORN).
• Centers for Medicare and Medicaid
Services (CMS) and Substance Abuse
and Mental Health Services
Administration (SAMHSA) System
Manager information has been updated.
• In the Categories of Records section,
additional examples of records (license
application, data protection plan, and
Institutional Review Board (IRB)
approval records) have been added.
• Routine use 6, authorizes
disclosures to the U.S. Department of
Justice (DOJ) or a court in litigation, has
been revised to change ‘‘litigation’’ to
‘‘litigation or other proceedings’’ and to
remove wording that required the
disclosures to be compatible with the
purpose the original disclosed
information was collected, which is
redundant because it repeats part of the
definition of a routine use.
• The sections specifying procedures
for making access, amendment, and
notification requests have been revised
to reference HHS’ Privacy Act
regulations in 45 CFR; to state that the
requests must contain the requester’s
full name, address, date of birth, and
signature; and to require identity
verification in the Contesting Records
Procedures section and state that the
right to contest records is limited to
information that is factually inaccurate,
incomplete, irrelevant, or untimely
(obsolete).
‘‘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;
or because they contain other types of
data that require confidentiality
protection (for example, proprietary
business data submitted to HHS with
restrictions imposed by the submitting
entity). The datasets and products are
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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, or to
protect proprietary business interests or
other interests needing confidentiality
protection. 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
or to reveal proprietary data or other
protected 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
enforce the restrictions, it is necessary
to collect information about the data
requesters.
The modified system of records will
cover records in the following five
information technology (IT) systems, or
any successor IT systems, about
requesters of restricted datasets:
• Administration for Children &
Families, Children’s Bureau (ACF/CB)
‘‘National Data Archive on Child Abuse
and Neglect (NDACAN).’’ NDACAN is a
data repository maintained by a
contractor funded by ACF’s Children’s
Bureau, containing deidentified child
abuse and neglect data from national
surveys, large-scale longitudinal
surveys, state administrative data, and
data collected by individual
investigators. NDACAN delivers
distributable datasets to researchers who
apply for and receive a license. No
distributable datasets contain
information that is directly identifying;
however, some are restricted because
they have the potential to identify
particular individuals if combined with
other data, and thus require researchers
to not only obtain a license but also
submit a data protection plan and obtain
Institutional Review Board (IRB)
approval to receive the dataset. Records
about researcher-applicants who seek
restricted datasets (including the license
application, data protection plan, and
IRB approval records) are retrieved by
the researcher-applicant’s name or other
personal identifier, so are Privacy Act
records. (NDACAN also collects
identifiable customer information about
researchers who seek unrestricted
datasets, in order to deliver its products
and services to them; however, because
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minimal information is collected about
them, it would be covered by system of
records 09–90–1901 if it is retrieved by
personal identifier; see the below
‘‘Note.’’)
• 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) Data Use Agreement
(DUA) tracking system. This system
tracks disclosures of data containing
Protected Health Information (PHI) or
Personally Identifiable Information (PII),
including authorization, payment status,
and shipping status of 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’’ that 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 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
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
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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
make restricted datasets from SAMHSA
more efficiently 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 they 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: 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 they
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, 09–90–1901, HHS
Correspondence, Comment, Customer
Service, and Contact List Records and
09–90–0024 HHS Financial
Management System Records), 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
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information products; and records about
requesters ordering unrestricted datasets
from CMS’s DUA tracking system
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 modified system of
records has been sent to OMB and
Congress in accordance with 5 U.S.C.
552a(r).
Rebecca Jones Gaston,
Commissioner, Administration on Children,
Youth and Families.
SYSTEM NAME AND NUMBER:
Records About Requesters of
Restricted Datasets, 09–90–1401.
SECURITY CLASSIFICATION:
Unclassified.
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SYSTEM LOCATION:
The address of each agency
component responsible for the system of
records is:
• ACF: Child Welfare Program
Specialist, Children’s Bureau,
Administration for Children and
Families, 330 C Street SW, Washington,
DC 20201.
• 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 Blvd., 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 Fishers Lane,
Rockville, MD 20857.
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SYSTEM MANAGER(S):
• ACF: Child Welfare Program
Specialist, Children’s Bureau,
Administration for Children and
Families, 330 C Street SW, Washington,
DC 20201; Email: cara.kelly@
acf.hhs.gov, or 202–205–8636.
• 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, Office
of Enterprise Data and Analytics, Data &
Information Dissemination Group,
Centers for Medicare & Medicaid
Services, 7500 Security Blvd., Mailstop:
B2–29–04, Office Location: B2–03–37,
Baltimore, MD 21244–1870;
datauseagreement@cms.hhs.gov.
• 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 Fishers Lane,
Rockville, MD 20857; 877–726–4727.
(‘‘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:
• ACF: 42 U.S.C. 5101 et seq.; 45 CFR
1355.40 and 1356.80 through 1356.86.
• AHRQ: 42 U.S.C. 299 through 299a
and 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,
and 284; 48 CFR subpt. 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.
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
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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:
PURPOSE(S) OF THE SYSTEM:
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The records are about 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:
The categories of records include:
• Request records, containing the
requester’s name and contact
information (telephone number, mailing
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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., license
application; affidavit of nondisclosure;
declaration of nondisclosure;
confidential data use and nondisclosure
agreement (CDUNA); data protection
plan; individual designations of agent;
DUA number and expiration date;
Institutional Review Board (IRB)
approval records), 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.
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ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
PURPOSES OF SUCH USES:
Information about an individual
dataset requester may be disclosed to
parties outside HHS, without that
individual’s 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
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will be required to comply with the
requirements of the Privacy Act.
2. Records may be disclosed to
student volunteers, individuals working
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,
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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, in litigation or
other proceedings, 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 the proceedings or has an
interest in the proceedings and, by
careful review, HHS determines that the
records are both relevant and necessary
to the proceedings.
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
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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 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
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Administration (GSA), or other relevant
federal 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) through (11).
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
Records are stored in electronic
databases and hard-copy files. CMS’
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 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 ACF and SAMHSA records
will be retained indefinitely until a
disposition schedule is approved by the
National Archives and Records
Administration (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 HHS policies,
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/.
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72485
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, and
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 access
records about him or her in this system
of records must submit a written access
request to the relevant System Manager
at the address indicated in the ‘‘System
Manager(s)’’ section above, in
accordance with the Department’s
Privacy Act implementation regulations
in 45 CFR. The request must contain the
requester’s full name, address, date of
birth, and signature. 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 fine
of up to $5,000.
CONTESTING RECORD PROCEDURES:
An individual seeking to correct a
record about him or her in this system
of records must submit a written
correction request to the relevant
System Manager at the address
indicated in the ‘‘System Manager(s)’’
section above, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request must contain the requester’s
full name, address, date of birth, and
signature, reasonably identify the
record, specify the information
contested, and state the corrective
action sought and the reasons for the
correction. The request should include
any supporting documentation. The
individual must verify his or her
identity in the same manner required for
an access request. The right to contest
records is limited to information that is
factually inaccurate, incomplete,
irrelevant, or untimely (obsolete).
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72486
Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system of records contains a record
about him or her must submit a written
notification request to the relevant
System Manager at the address
indicated in the ‘‘System Manager(s)’’
section above, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request must contain the requester’s
full name, address, date of birth, and
signature. The individual must verify
his or her identity in the same manner
required for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
83 FR 11213 (Mar. 14, 2018).
[FR Doc. 2023–23147 Filed 10–19–23; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1272]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Third Party
Disclosure and Recordkeeping
Requirements for Reportable Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by November
20, 2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0643. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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18:20 Oct 19, 2023
Jkt 262001
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Third Party Disclosure and
Recordkeeping Requirements for
Reportable Food—21 U.S.C. 350f
OMB Control Number 0910–0643—
Extension
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Food and Drug Administration
Amendments Act of 2007 (FDAAA)
(Pub. L. 110–85), requires the
establishment of a Reportable Food
Registry (the Registry) by which
instances of reportable food must be
submitted to FDA by responsible parties
and may be submitted by public health
officials. Section 417 of the FD&C Act
(21 U.S.C. 350f) defines ‘‘reportable
food’’ as an article of food (other than
infant formula) for which there is a
reasonable probability that the use of, or
exposure to, such article of food will
cause serious adverse health
consequences or death to humans or
animals. (See section 417(a)(2) of the
FD&C Act.) We believe that the most
efficient and cost-effective means to
implement the Registry is by utilizing
our electronic Safety Reporting Portal.
The information collection provisions
associated with the submission of
reportable food reports has been
approved under OMB control number
0910–0291.
In conjunction with the reportable
foods requirements, section 417 of the
FD&C Act also establishes third-party
disclosure and recordkeeping burdens.
Specifically, we may require the
responsible party to notify the
immediate previous source(s) and/or
immediate subsequent recipient(s) of a
reportable food (sections 417(d)(6)(B)(i)
to (ii) of the FD&C Act). Similarly, we
may also require the responsible party
that is notified (i.e., the immediate
previous source and/or immediate
subsequent recipient) to notify their
own immediate previous source(s) and/
or immediate subsequent recipient(s) of
a reportable food (sections
417(d)(7)(C)(i) to (ii) of the FD&C Act).
Notification to the immediate
previous source(s) and immediate
subsequent recipient(s) of the article of
food may be accomplished by electronic
communication methods such as email,
fax, or text messaging or by telegrams,
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Fmt 4703
Sfmt 4703
mailgrams, or first-class letters.
Notification may also be accomplished
by telephone call or other personal
contacts, but we recommend that such
notifications also be confirmed by one
of the previous methods and/or
documented in an appropriate manner.
We may require that the notification
include any or all of the following data
elements: (1) the date on which the
article of food was determined to be a
reportable food; (2) a description of the
article of food including the quantity or
amount; (3) the extent and nature of the
adulteration; (4) the results of any
investigation of the cause of the
adulteration if it may have originated
with the responsible party, if known; (5)
the disposition of the article of food,
when known; (6) product information
typically found on packaging including
product codes, use-by dates, and the
names of manufacturers, packers, or
distributors sufficient to identify the
article of food; (7) contact information
for the responsible party; (8) contact
information for parties directly linked in
the supply chain and notified under
section 417(d)(6)(B) or 417(d)(7)(C) of
the FD&C Act, as applicable; (9) the
information required by FDA to be
included in the notification provided by
the responsible party involved under
section 417(d)(6)(B) or 417(d)(7)(C) of
the FD&C Act or required to report
under section 417(d)(7)(A) of the FD&C
Act; and (10) the unique number
described in section 417(d)(4) of the
FD&C Act (section 417(d)(6)(B)(iii)(I),
(d)(7)(C)(iii)(I), and (e) of the FD&C Act).
We may also require that the
notification provides information about
the actions that the recipient of the
notification will perform and/or any
other information we may require
(section 417(d)(6)(B)(iii)(II) and (III) and
(d)(7)(C)(iii)(II) and (III) of the FD&C
Act).
Section 417(g) of the FD&C Act
requires that responsible persons
maintain records related to reportable
foods for a period of 2 years.
The congressionally-identified
purpose of the Registry is to provide a
reliable mechanism to track patterns of
adulteration in food which would
support efforts by FDA to target limited
inspection resources to protect the
public health (see FDAAA, section
1005(a)(4)). The reporting and
recordkeeping requirements described
previously are designed to enable FDA
to quickly identify and track an article
of food (other than infant formula) for
which there is a reasonable probability
that the use of or exposure to such
article of food will cause serious adverse
health consequences or death to humans
or animals. We use the information
E:\FR\FM\20OCN1.SGM
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Agencies
[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72481-72486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23147]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Privacy Act of 1974; System of Records
AGENCY: Administration for Children and Families, Department of Health
and Human Services.
ACTION: Notice of a modified system of records.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, as amended, the Department of Health and Human Services (HHS) is
altering an existing department wide system of records, ``Records About
Restricted Dataset Requesters,'' System Number 09-90-1401, to add
records maintained by HHS' Administration for Children and Families
(ACF) and to make other changes, including changing the system of
records name to ``Records About Requesters of Restricted Datasets.''
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.
DATES: In accordance with 5 U.S.C. 552a(e)(4) and (11), this modified
system of records is effective October 20, 2023, subject to a 30-day
comment period on the revised routine use described below. Please
submit any comments by November 20, 2023.
ADDRESSES: The public should submit written comments, by mail or email,
to Anita Alford, Senior Official for Privacy, Administration for
Children and Families, 330 C Street SW, Washington, DC 20201, or
[email protected].
FOR FURTHER INFORMATION CONTACT: General questions about the system of
records should be submitted by mail or email to Beth Kramer, HHS
Privacy Act Officer, at 200 Independence Ave. SW--Suite 729H,
Washington, DC 20201, or [email protected], or (202) 690-6941.
SUPPLEMENTARY INFORMATION: This departmentwide system of records 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 record system they are retrieved directly by an
individual requester's name or other personal identifier. It currently
includes records maintained by four HHS Operating Divisions. It is
being revised to add records maintained by a fifth Operating Division,
the Administration for Children and Families (ACF), and to make other
changes, as explained below:
The system of records name has been changed to ``Records
About Requesters of Restricted Datasets.''
The alterations made to add ACF's records affect the
System Location, System Manager(s), Authorities, Categories of Records,
and Retention sections of the System of Records Notice (SORN).
Centers for Medicare and Medicaid Services (CMS) and
Substance Abuse and Mental Health Services Administration (SAMHSA)
System Manager information has been updated.
In the Categories of Records section, additional examples
of records (license application, data protection plan, and
Institutional Review Board (IRB) approval records) have been added.
Routine use 6, authorizes disclosures to the U.S.
Department of Justice (DOJ) or a court in litigation, has been revised
to change ``litigation'' to ``litigation or other proceedings'' and to
remove wording that required the disclosures to be compatible with the
purpose the original disclosed information was collected, which is
redundant because it repeats part of the definition of a routine use.
The sections specifying procedures for making access,
amendment, and notification requests have been revised to reference
HHS' Privacy Act regulations in 45 CFR; to state that the requests must
contain the requester's full name, address, date of birth, and
signature; and to require identity verification in the Contesting
Records Procedures section and state that the right to contest records
is limited to information that is factually inaccurate, incomplete,
irrelevant, or untimely (obsolete).
``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; or because
they contain other types of data that require confidentiality
protection (for example, proprietary business data submitted to HHS
with restrictions imposed by the submitting entity). The datasets and
products are
[[Page 72482]]
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, or to protect proprietary business interests or
other interests needing confidentiality protection. 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 or to reveal proprietary data or other protected 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 enforce the restrictions, it is
necessary to collect information about the data requesters.
The modified system of records will cover records in the following
five information technology (IT) systems, or any successor IT systems,
about requesters of restricted datasets:
Administration for Children & Families, Children's Bureau
(ACF/CB) ``National Data Archive on Child Abuse and Neglect (NDACAN).''
NDACAN is a data repository maintained by a contractor funded by ACF's
Children's Bureau, containing deidentified child abuse and neglect data
from national surveys, large-scale longitudinal surveys, state
administrative data, and data collected by individual investigators.
NDACAN delivers distributable datasets to researchers who apply for and
receive a license. No distributable datasets contain information that
is directly identifying; however, some are restricted because they have
the potential to identify particular individuals if combined with other
data, and thus require researchers to not only obtain a license but
also submit a data protection plan and obtain Institutional Review
Board (IRB) approval to receive the dataset. Records about researcher-
applicants who seek restricted datasets (including the license
application, data protection plan, and IRB approval records) are
retrieved by the researcher-applicant's name or other personal
identifier, so are Privacy Act records. (NDACAN also collects
identifiable customer information about researchers who seek
unrestricted datasets, in order to deliver its products and services to
them; however, because minimal information is collected about them, it
would be covered by system of records 09-90-1901 if it is retrieved by
personal identifier; see the below ``Note.'')
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) Data Use
Agreement (DUA) tracking system. This system tracks disclosures of data
containing Protected Health Information (PHI) or Personally
Identifiable Information (PII), including authorization, payment
status, and shipping status of 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''
that 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 make restricted datasets
from SAMHSA more efficiently 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 they 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: 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 they 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, 09-90-
1901, HHS Correspondence, Comment, Customer Service, and Contact List
Records and 09-90-0024 HHS Financial Management System Records), 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
[[Page 72483]]
information products; and records about requesters ordering
unrestricted datasets from CMS's DUA tracking system 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 modified system of records has been sent to OMB and
Congress in accordance with 5 U.S.C. 552a(r).
Rebecca Jones Gaston,
Commissioner, Administration on Children, Youth and Families.
SYSTEM NAME AND NUMBER:
Records About Requesters of Restricted Datasets, 09-90-1401.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of each agency component responsible for the system of
records is:
ACF: Child Welfare Program Specialist, Children's Bureau,
Administration for Children and Families, 330 C Street SW, Washington,
DC 20201.
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 Blvd., 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 Fishers Lane,
Rockville, MD 20857.
SYSTEM MANAGER(S):
ACF: Child Welfare Program Specialist, Children's Bureau,
Administration for Children and Families, 330 C Street SW, Washington,
DC 20201; Email: [email protected], or 202-205-8636.
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, Office of Enterprise Data and
Analytics, Data & Information Dissemination Group, Centers for Medicare
& Medicaid Services, 7500 Security Blvd., Mailstop: B2-29-04, Office
Location: B2-03-37, Baltimore, MD 21244-1870;
[email protected].
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 Fishers Lane,
Rockville, MD 20857; 877-726-4727. (``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:
ACF: 42 U.S.C. 5101 et seq.; 45 CFR 1355.40 and 1356.80
through 1356.86.
AHRQ: 42 U.S.C. 299 through 299a and 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, and 284; 48 CFR subpt.
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:
The records are about 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:
The categories of records include:
Request records, containing the requester's name and
contact information (telephone number, mailing
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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., license
application; affidavit of nondisclosure; declaration of nondisclosure;
confidential data use and nondisclosure agreement (CDUNA); data
protection plan; individual designations of agent; DUA number and
expiration date; Institutional Review Board (IRB) approval records),
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 dataset requester may be disclosed
to parties outside HHS, without that individual's 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 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, in litigation or other
proceedings, 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 the proceedings or
has an interest in the proceedings and, by careful review, HHS
determines that the records are both relevant and necessary to the
proceedings.
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
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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 federal 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) through (11).
POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
Records are stored in electronic databases and hard-copy files.
CMS' 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 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 ACF and
SAMHSA records will be retained indefinitely until a disposition
schedule is approved by the National Archives and Records
Administration (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 HHS policies, 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,
and 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 access records about him or her in this
system of records must submit a written access request to the relevant
System Manager at the address indicated in the ``System Manager(s)''
section above, in accordance with the Department's Privacy Act
implementation regulations in 45 CFR. The request must contain the
requester's full name, address, date of birth, and signature. 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 fine of up to $5,000.
CONTESTING RECORD PROCEDURES:
An individual seeking to correct a record about him or her in this
system of records must submit a written correction request to the
relevant System Manager at the address indicated in the ``System
Manager(s)'' section above, in accordance with the Department's Privacy
Act implementation regulations in 45 CFR. The request must contain the
requester's full name, address, date of birth, and signature,
reasonably identify the record, specify the information contested, and
state the corrective action sought and the reasons for the correction.
The request should include any supporting documentation. The individual
must verify his or her identity in the same manner required for an
access request. The right to contest records is limited to information
that is factually inaccurate, incomplete, irrelevant, or untimely
(obsolete).
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NOTIFICATION PROCEDURES:
An individual who wishes to know if this system of records contains
a record about him or her must submit a written notification request to
the relevant System Manager at the address indicated in the ``System
Manager(s)'' section above, in accordance with the Department's Privacy
Act implementation regulations in 45 CFR. The request must contain the
requester's full name, address, date of birth, and signature. The
individual must verify his or her identity in the same manner required
for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
83 FR 11213 (Mar. 14, 2018).
[FR Doc. 2023-23147 Filed 10-19-23; 8:45 am]
BILLING CODE 4184-29-P