Privacy Act of 1974; System of Records, 43407-43411 [2024-10838]
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Federal Register / Vol. 89, No. 97 / Friday, May 17, 2024 / Notices
requirement to cover EHB (45 CFR
147.150 and 156.115).
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Medical Necessity Disclosure Under
MHPAEA
MHPAEA specifically amends the
Public Health Service (PHS) Act to
require plan administrators or health
insurance issuers to provide, upon
request, the criteria for medical
necessity determinations made with
respect to MH/SUD benefits to current
or potential participants, beneficiaries,
or contracting providers. The Final
Rules under MHPAEA set forth rules for
providing criteria for medical necessity
determinations. CMS administers
MHPAEA with respect to self-insured,
non-Federal governmental plans in all
States, and health insurance issuers in
two States.
Claims Denial Disclosure Under
MHPAEA
MHPAEA specifically amends the
PHS Act to require plan administrators
or health insurance issuers to provide,
upon request, the reason for any denial
or reimbursement of payment for MH/
SUD services to the participant or
beneficiary involved in the case. The
Final Rules under MHPAEA at 45 CFR
146.136(d)(2) implement MHPAEA.
CMS administers MHPAEA with respect
to self-insured, non-Federal
governmental plans in all States and
health insurance issuers in two States,
and the regulation provides a safe
harbor such that non-Federal
governmental plans (and issuers offering
coverage in connection with such plans)
are deemed to comply with
requirements of paragraph (d)(2) of 45
CFR 146.136 if they provide the reason
for claims denial in a form and manner
consistent with ERISA requirements
found in 29 CFR 2560.503–1. Section
146.136(d)(3) clarifies that PHS Act
section 2719 governing internal claims
and appeals and external review as
implemented by 45 CFR 147.136, covers
MHPAEA claims denials and requires
that, when a non-quantitative treatment
limitation (NQTL) is the basis for a
claims denial, that a non-grandfathered
plan or issuer must provide the
processes, strategies, evidentiary
standard, and other factors used in
developing and applying the NQTL with
respect to med/surg benefits and MH/
SUD benefits.
Disclosure Request Form
Group health plan participants,
beneficiaries, covered individuals in the
individual market, or persons acting on
their behalf, may use this optional
model form to request information from
plans regarding the medical necessity
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and claims denials disclosures
referenced above. Form Number: CMS–
10307 (OMB control number: 0938–
1080); Frequency: On Occasion;
Affected Public: State, Local, or Tribal
Governments, Private Sector,
Individuals; Number of Respondents:
282,657; Total Annual Responses:
1,125,558; Total Annual Hours: 93,797.
(For policy questions regarding this
collection contact Erik Gomez at 667–
414–0682.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–10900 Filed 5–16–24; 8:45 am]
BILLING CODE 4120–01–P
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 modifying
an existing system of records
maintained by the Administration for
Children and Families (ACF), Office of
Child Support Services (OCSS): System
No. 09–80–0389, ‘‘OCSE Data Center
General Support System,’’ being
renamed ‘‘OCSS Data Exchange
Platform.’’
SUMMARY:
This Notice is applicable May
17, 2024, subject to a 30-day period in
which to comment on the new and
revised routine uses, described below.
Please submit any comments by June 17,
2024.
ADDRESSES: The public should address
written comments by mail or email to:
Anita Alford, Senior Official for Privacy,
Administration for Children and
Families, 330 C St. SW, Washington, DC
20201, or by email to anita.alford@
acf.hhs.gov.
DATES:
FOR FURTHER INFORMATION CONTACT:
General questions about these system of
records should be submitted by mail or
email to Venkata Kondapolu, Director,
Division of Federal Systems, Office of
Child Support Services, at 330 C St.
SW—5th Floor, Washington, DC 20201,
PO 00000
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43407
or venkata.kondapolu@acf.hhs.gov, or
by phone at 202–260–4712.
SUPPLEMENTARY INFORMATION:
I. Explanation of Changes to System of
Records 09–80–0381
In accordance with 5 U.S.C. 552a(e)(4)
and (11), HHS is modifying an existing
system of records maintained by ACF/
OCSS: System No. 09–80–0389, being
renamed ‘‘OCSS Data Exchange
Platform.’’ The system of records covers
records supporting State and Tribal
child support programs, and the
program’s external stakeholders, which
are exchanged electronically using a
secure data exchange platform (the
OCSS Data Exchange Platform, or any
successor system) provided by OCSS.
The data exchange platform facilitates
electronic exchanges of information
about individual participants in child
support cases, between State child
support agencies and other external
partners such as employers, health plan
administrators, financial institutions,
and central authorities in foreign treaty
countries or foreign countries that are
the subject of a declaration under 42
U.S.C. 659a. The child support agencies
and other external partners use the data
exchange platform to electronically
submit information to and receive
information from each other, through
OCSS.
The System of Records Notice (SORN)
for system of records 09–80–0389 has
been modified as follows:
• The system of records name has
been changed to ‘‘OCSS Data Exchange
Platform’’ to reflect the name change of
the ‘‘Office of Support Enforcement’’ to
the ‘‘Office of Child Support Services’’
and to provide a more meaningful name
for the system of records.
• The System Manager(s) section has
been revised to change the office name
to Office of Child Support Services.
• The Purpose(s) section has been
revised to describe the system as a data
exchange platform, rather than as a
‘‘gateway system,’’ and one purpose, at
the end of the section, has been
expanded to include the use of the data
exchange platform by foreign authorities
to transmit case information associated
with child support disbursements
transmitted from a foreign authority to
the United States through the Central
Authority Payment (CAP) service.
• The Categories of Records section
has been revised to make these changes
to Category (4):
Æ The phrase ‘‘which includes’’ has
been changed to ‘‘which may include.’’
Æ Under (4)(c), ‘‘agency’s case
number’’ had been changed to ‘‘agency’s
case identifier.’’
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• The Record Source Categories
section has been revised as follows:
Æ The description of State child
support agencies transmitting payment
information to the CAP program has
been modified to ‘‘exchanging caserelated information associated with
child support disbursements
transmitted to foreign authorities
through the CAP service.’’
Æ An additional category has been
added: ‘‘[F]oreign authorities
exchanging case-related information
associated with child support
disbursements transmitted to State child
support agencies through the CAP
service.’’
• The Routine Uses section has been
updated as follows:
Æ The word ‘‘enforcement’’ has been
removed from routine uses 1, 2, 4, and
6.
Æ Routine use 11 has been revised to
include disclosure of information
involving residents of foreign treaty
countries or foreign reciprocating
countries to State child support
programs for child support purposes.
• The Policies and Practices for
Retention and Disposal of Records
section has been revised to include
General Records Schedule 5.2, items
010 and 020 as the applicable
disposition authority.
Venkata Kondapolu,
Director, Division of Federal Systems, Office
of Child Support Services, Administration for
Children and Families, U.S. Department of
Health and Human Services.
SYSTEM NAME AND NUMBER:
OCSS Data Exchange Platform, 09–
80–0389.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
Office of Child Support Services,
Administration for Children and
Families, 330 C St. SW, 5th Floor,
Washington, DC 20201.
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SYSTEM MANAGER(S):
Director, Division of Federal Systems,
Office of Child Support Services,
Administration for Children and
Families, Department of Health and
Human Services, 330 C St. SW, 5th
Floor, Washington, DC 20201,
Venkata.Kondapolu@acf.hhs.gov, 202–
260–4712.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 652, 654, 654a, 654b, 659,
659a, 666, 669a.
PURPOSE(S) OF THE SYSTEM:
The purpose of the system of records
is to cover records supporting State and
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Tribal child support programs, and the
programs’ external stakeholders, which
are exchanged electronically using a
secure data exchange platform provided
by OCSS. The platform facilitates
electronic exchanges of information
about individual participants in child
support cases, between State child
support agencies and other external
partners such as employers, health plan
administrators, financial institutions,
and central authorities in foreign treaty
countries or foreign countries that are
the subject of a declaration under 42
U.S.C. 659a. The child support agencies
and other external partners use the data
exchange platform to electronically
submit information to and receive
information from each other, through
OCSS.
The platform supports, for example:
• The Electronic Income Withholding
Order (e-IWO) program, which provides
the means to electronically exchange
income withholding order information
between State child support agencies
and employers.
• The Electronic National Medical
Support Notice (e-NMSN) program,
which allows State child support
agencies, employers, and health plan
administrators to electronically send
and receive National Medical Support
Notices used to enroll children in
medical insurance plans pursuant to
child support orders.
• The Federally Assisted State
Transmitted (FAST) Levy program,
which allows States and financial
institutions to exchange information
about levy actions through an electronic
process.
• The Central Authority Payment
(CAP) service, which allows States and
foreign authorities to exchange details of
child support disbursements
transmitted between the United States
and the authorized entity of the foreign
treaty country or foreign country subject
of a declaration under 42 U.S.C. 659a for
distribution of the support payment by
the foreign authority or the State child
support agency in accordance with the
terms of the order.
Multiple child support program
partners utilize the platform to
electronically send and receive
information:
State child support agencies use the
platform to transmit e-IWOs to
employers and e-NMSNs to employers
and health plan administrators. State
child support agencies also use the
platform to create levy actions for
distribution to multiple financial
institutions, and to transmit information
about child support disbursements
between U.S. States and foreign
authorities through the CAP service.
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Employers use the platform to
respond to State child support agencies
regarding e-IWOs and to provide
information about health insurance
coverage provided by the employer.
Employers and health plan
administrators use the platform to
respond to State child support agencies
regarding e-NMSNs.
Financial institutions use the platform
to receive and respond to levy actions
from multiple State child support
agencies.
U.S. States and foreign authorities use
the platform to transmit case
information associated with child
support disbursements transmitted
between the United States and a foreign
authority through the CAP service.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The records in the system of records
are about custodial and noncustodial
parents, legal guardians, and third-party
caretakers who are participants in child
support program cases and whose
names and Social Security numbers
(SSNs) are used to retrieve the records.
Children’s personal identifiers are not
used to retrieve records in this system
of records, so children are not subject
individuals for purposes of this system
of records.
CATEGORIES OF RECORDS IN THE SYSTEM:
The categories of records exchanged
in the platform include:
1. Child support case information
used to populate an e-IWO, which may
include:
a. Name of State, Tribe, territory, or
private individual entity issuing an eIWO;
b. Order ID and Case ID;
c. Remittance ID;
d. Employer/income withholder
name, address, Federal employer
identification number (FEIN), telephone
number, FAX number, email, or
website;
e. Employee/obligor’s name, Social
Security number (SSN), date of birth;
f. Custodial parent’s/obligee’s name;
g. Child(ren)’s name(s) and date(s) of
birth;
h. Income withholding amounts for
current child support, past-due child
support, current cash medical support,
past-due cash medical support, current
spousal support, past-due spousal
support;
i. Child support State disbursement
unit or Tribal order payee name and
address;
j. Judge/issuing official’s name, title,
and signature; and
k. Employee/obligor termination date,
last known telephone number, last
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known address, new employer/income
withholder’s name and address.
2. Child support case information
used to populate an e-NMSN, and
medical insurance information included
in e-NMSN responses from employers
and health plan administrators, which
may include:
a. Custodial parent/obligee’s name
and mailing address;
b. Substituted official/agency name
and address (if custodial parent/
obligee’s address is left blank);
c. Name, telephone number, and
mailing address of representative of
child(ren);
d. Child(ren)’s name(s), gender, date
of birth, and SSN;
e. Employee’s name, SSN, and
mailing address;
f. Plan administrator name, contact
person, FAX number and telephone
number;
g. Employer and/or employer
representative name, FEIN, and
telephone number;
h. Date of medical support
termination, reason for termination, and
child(ren) to be terminated from
medical support;
i. Medical insurance provider name,
group number, policy number, address;
j. Dental insurance provider name,
group number, policy number, address;
k. Vision insurance provider name,
group number, policy number, address;
l. Prescription drug insurance
provider name, group number, policy
number, address;
m. Mental health insurance provider
name, group number, policy number,
address;
n. Other insurance, specified by
name, group number, policy number,
address; and
o. Plan administrator name, title,
telephone number and address.
3. Child support case information
used to administer the FAST Levy
program, which includes:
a. Requesting State agency name,
address, and State Federal Information
Processing Standard (FIPS) code;
b. Financial institution’s name and
FEIN;
c. Obligor’s name, SSN, and date of
birth;
d. Account number of account from
which to withhold funds;
e. Withholding amount; and
f. Contact name, phone number, and
email for point of contact in requesting
State.
4. Child support case information
used to administer the CAP service,
which may include:
a. Obligor/non-custodial parent’s
name and SSN;
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b. Foreign authority name, FIPS
locator code, and foreign authority’s
child support case identifier;
c. U.S. State name and State child
support agency’s case identifier;
d. Amount and date of payment;
e. Medical support indicator; and
f. Employment termination indicator.
RECORD SOURCE CATEGORIES:
The sources of the information in the
system of records include:
• State child support agencies
initiating e-IWO, e-NMSN, and FAST
Levy program transactions in domestic
child support cases and exchanging
case-related information associated with
child support disbursements
transmitted to foreign authorities
through the CAP service.
• Employers or authorized third
parties responding to e-IWOs and eNMSNs.
• Health plan administrators
responding to e-NMSNs.
• Financial institutions responding to
FAST Levy requests.
• Foreign authorities exchanging
case-related information associated with
child support disbursements
transmitted to State child support
agencies through the CAP service.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
PURPOSES OF SUCH USES:
In addition to the disclosures
authorized directly in the Privacy Act at
5 U.S.C. 552a(b)(1) and (b)(2) and (b)(4)
through (b)(11), these routine uses
specify circumstances under which the
agency may disclose information from
this system of records to a non-HHS
officer or employee without the consent
of the data subject. ACF will prohibit
redisclosures, or may permit only
certain redisclosures, as required or
authorized by law. Each proposed
disclosure or redisclosure of
information permitted directly in the
Privacy Act or under these routine uses
will be evaluated to ensure that the
disclosure or redisclosure is legally
permissible.
Any information defined as ‘‘return’’
or ‘‘return information’’ under 26 U.S.C.
6103 (Internal Revenue Code) is not
disclosed unless authorized by a statute,
the Internal Revenue Service (IRS), or
IRS regulations.
1. Disclosure to Financial Institution
to Collect Past-Due Support.
Pursuant to 42 U.S.C. 652(l),
information pertaining to an individual
owing past-due child support may be
disclosed to a financial institution doing
business in two or more States to
identify an individual who maintains an
account at the institution for the
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43409
purpose of collecting past-due support.
Information pertaining to requests by
the State child support agencies for the
placement of a lien or levy of such
accounts may also be disclosed.
2. Disclosure of Financial Institution
Information to State Child Support
Agency for Assistance in Collecting
Past-Due Support.
Pursuant to 42 U.S.C. 652(l), the
results of a comparison between
information pertaining to an individual
owing past-due child support and
information provided by multistate
financial institutions may be disclosed
to a State child support agency for the
purpose of assisting the State agency in
collecting past-due support. Information
pertaining to responses to requests by a
State child support agency for the
placement of a lien or levy of such
accounts may also be disclosed.
3. Disclosure to Employer to Enforce
Child Support Obligations.
Pursuant to 42 U.S.C. 666(b),
information pertaining to an individual
owing current or past-due child support
may be disclosed to an employer for the
purpose of collecting current or pastdue support by way of an e-IWO.
4. Disclosure of Employer Information
to State Child Support Agency in
Response to an e-IWO.
Information pertaining to a response
by an employer to an e-IWO issued by
a State child support agency for the
collection of child support may be
disclosed to the State child support
agency.
5. Disclosure to Employer and Health
Plan Administrator to Enforce Medical
Support Obligations.
Pursuant to 42 U.S.C. 666(a)(19),
information pertaining to participants in
a child support case may be disclosed
to an employer or a health plan
administrator for the purpose of
enforcing medical support for a child by
way of an e-NMSN.
6. Disclosure of Employer and Health
Plan Administrator Information to State
Child Support Agency in Response to an
e-NMSN.
Information pertaining to a response
by an employer or a health plan
administrator to an e-NMSN issued by
a State child support agency for the
enforcement of medical support may be
disclosed to the State child support
agency.
7. Disclosure to Department of Justice
or in Proceedings.
Records may be disclosed to the
Department of Justice (DOJ) or to a court
or other adjudicative body in litigation
or other proceedings when HHS or any
of its components, or any employee of
HHS acting in the employee’s official
capacity, or any employee of HHS acting
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in the employee’s individual capacity
where the DOJ or HHS has agreed to
represent the employee, or 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.
8. Disclosure to Congressional Office.
Information may be disclosed to a
congressional office from the record of
an individual in response to a written
inquiry from the congressional office
made at the written request of the
individual.
9. Disclosure to Contractor to Perform
Duties.
Records may be disclosed to a
contractor performing or working on a
contract for HHS and who has a need to
have access to the information in the
performance of its duties or activities for
HHS in accordance with law and with
the contract.
10. Disclosure in the Event of a
Security Breach.
a. Information may be disclosed 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’s efforts to
respond to the suspected or confirmed
breach or to prevent, minimize, or
remedy such harm.
b. Information may be disclosed 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.
11. Disclosure to a Foreign
Reciprocating Country, Foreign Treaty
Country, and State Child Support
Program for Child Support Purposes.
Pursuant to 42 U.S.C. 652(n),
653(a)(2), 653(c)(5) and 659a(c)(2), child
support case information involving
residents of the United States and
residents of foreign treaty countries or
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foreign countries that are the subject of
a declaration under 42 U.S.C. 659a may
be disclosed to the foreign authority and
to State child support programs.
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
The records are stored electronically.
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
Records are retrieved by the parent’s,
guardian’s or third-party caretaker’s
name or SSN.
POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
Because the platform is not a source
system but facilitates access to records
from other systems which are the
official sources of the records, the
records are retained and disposed of in
accordance with General Records
Schedule 5.2 Transitory and
Intermediary Records, Items 010 and
020 (DAA–GRS–2022–0009–0001 and
DAA–GRS–2022–0009–0002), which
provides these disposition periods:
• Item 010 Transitory records:
Destroy when no longer needed for
business use, or according to an agency
predetermined time period or business
rule.
• Item 020 Intermediary records:
Destroy upon creation or update of the
final record, or when no longer needed
for business use, whichever is later.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
The platform leverages cloud service
providers that maintain an authority to
operate in accordance with applicable
laws, rules, and policies, including
Federal Risk and Authorization
Management Program (FedRAMP)
requirements. Specific administrative,
technical, and physical controls are in
place to ensure that the records
collected, maintained, and transmitted
using the platform are secure from
unauthorized access. Access to the
records within the system is restricted
to authorized personnel who are
advised of the confidentiality of the
records and the civil and criminal
penalties for misuse and who sign a
nondisclosure oath to that effect.
Agency personnel are provided privacy
and security training before being
granted access to the records and
annually thereafter. Additional
safeguards include protecting the
facilities where records are stored or
accessed with security guards, badges
and cameras; limiting access to
electronic databases to authorized users
based on roles and either two-factor
authentication or user ID and password
(as appropriate); using a secured
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operating system protected by
encryption, firewalls, and intrusion
detection systems; reviewing security
controls on a periodic basis; and using
secure destruction methods prescribed
in NIST SP 800–88 to dispose of eligible
records. All safeguards conform to the
HHS Information Security and Privacy
Program, https://www.hhs.gov/ocio/
securityprivacy/.
RECORD ACCESS PROCEDURES:
To request access to a record about
you in this system of records, submit a
written access request to the System
Manager identified in the ‘‘System
Manager’’ section of this System of
Records Notice (SORN). The request
must reasonably describe the record
sought and must include (for contact
purposes and identity verification
purposes) your full name, current
address, telephone number and/or email
address, date and place of birth, and
signature, and (if needed by the agency)
sufficient particulars contained in the
records (such as, your SSN) to enable
the System Manager to distinguish
between records on subject individuals
with the same name. In addition, to
verify your identity, your signature must
be notarized, or the request must
include your written certification that
you are the individual who you claim to
be and that you understand that the
knowing and willful request for or
acquisition of a record pertaining to an
individual under false pretenses is a
criminal offense subject to a fine of up
to $5,000. You may request that copies
of the records be sent to you, or you may
request an appointment to review the
records in person (including with a
person of your choosing, if you provide
written authorization for agency
personnel to discuss the records in that
person’s presence). You may also
request an accounting of disclosures
that have been made of records about
you, if any.
CONTESTING RECORD PROCEDURES:
To request correction of a record
about you in this system of records,
submit a written amendment request to
the System Manager identified in the
‘‘System Manager’’ section of this
SORN. The request must contain the
same information required for an access
request and include verification of your
identity in the same manner required for
an access request. In addition, the
request must reasonably identify the
record and specify the information
contested, the corrective action sought,
and the reasons for requesting the
correction; and should include
supporting information to show how the
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record is inaccurate, incomplete,
untimely, or irrelevant.
Submit written requests for
a single copy of the revocations to the
Office of Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
revocations may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocations.
FOR FURTHER INFORMATION CONTACT: Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (this is not a toll-free
number).
ADDRESSES:
NOTIFICATION PROCEDURES:
To find out if the system of records
contains a record about you, submit a
written notification request to the
System Manager identified in the
‘‘System Manager’’ section of this
SORN. The request must identify this
system of records, contain the same
information required for an access
request, and include verification of your
identity in the same manner required for
an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
87 FR 69026 (Nov. 17, 2022).
[FR Doc. 2024–10838 Filed 5–16–24; 8:45 am]
BILLING CODE 4184–42–P
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
Food and Drug Administration
[Docket No. FDA–2022–N–0150]
Revocation of Two Authorizations of
Emergency Use of In Vitro Diagnostic
Device for Detection and/or Diagnosis
of COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorizations (EUAs) (the
Authorizations) issued to Bio-Rad
Laboratories Inc., for the Bio-Rad SARS–
CoV–2 ddPCR Kit, and Fast Track
Diagnostics Luxembourg S.á.r.l. (A
Siemens Healthineers Company), for the
FTD SARS–CoV–2. FDA revoked the
Authorizations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) as
requested by the Authorization holders.
The revocations, which include an
explanation of the reasons for each
revocation, are reprinted at the end of
this document.
DATES: The revocation of the
Authorization for the Bio-Rad
Laboratories Inc.’s Bio-Rad SARS–CoV–
2 ddPCR Kit is effective as of March 27,
2024. The revocation of the
Authorization for the Fast Track
Diagnostics Luxembourg S.á.r.l.’s (A
Siemens Healthineers Company), FTD
SARS–CoV–2 is effective as of April 18,
2024.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:20 May 16, 2024
Jkt 262001
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
radiological, or nuclear agent or agents.
Among other things, section 564 of the
FD&C Act allows FDA to authorize the
use of an unapproved medical product
or an unapproved use of an approved
medical product in certain situations.
On May 1, 2020, FDA issued the
Authorization to Bio-Rad Laboratories
Inc., for the Bio-Rad SARS–CoV–2
ddPCR Kit, subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on July 14, 2020 (85 FR
42409), as required by section 564(h)(1)
of the FD&C Act.
On May 5, 2020, FDA issued the
Authorization to Fast Track Diagnostics
Luxembourg S.á.r.l. (a Siemens
Healthineers Company) for the FTD
SARS–CoV–2, subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on July 14, 2020 (85 FR
42409), as required by section 564(h)(1)
of the FD&C Act.
Subsequent updates to the
Authorizations were made available on
FDA’s website. The authorization of a
device for emergency use under section
564 of the FD&C Act may, pursuant to
section 564(g)(2) of the FD&C Act, be
revoked when the criteria under section
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
43411
564(c) of the FD&C Act for issuance of
such authorization are no longer met
(section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such
revocation appropriate to protect the
public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. Authorizations Revocation Requests
In a request received by FDA on
March 16, 2024, Bio-Rad Laboratories
Inc., requested the revocation of, and on
March 27, 2024, FDA revoked, the
Authorization for the Bio-Rad
Laboratories Inc.’s Bio-Rad SARS–CoV–
2 ddPCR Kit. Because Bio-Rad
Laboratories Inc., notified FDA that they
ceased United States distribution of the
Bio-Rad SARS–CoV–2 ddPCR Kit and
requested FDA revoke Bio-Rad
Laboratories Inc.’s Bio-Rad SARS–CoV–
2 ddPCR Kit, FDA has determined that
it is appropriate to protect the public
health or safety to revoke this
Authorization.
In a request received by FDA on April
11, 2024, Fast Track Diagnostics
Luxembourg S.á.r.l. (a Siemens
Healthineers Company), requested the
deregister of, and on April 18, 2024,
FDA revoked, the Authorization for Fast
Track Diagnostics Luxembourg S.á.r.l.’s
FTD SARS–CoV–2. Because Fast Track
Diagnostics Luxembourg S.á.r.l. notified
FDA that they have ceased United States
distribution of the FTD SARS–CoV–2
and requested FDA deregister the Fast
Track Diagnostics Luxembourg S.á.r.l.’s
FTD SARS–CoV–2, FDA has determined
that it is appropriate to protect the
public health or safety to revoke this
Authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
revocations are available on the internet
at https://www.regulations.gov/.
IV. The Revocations
Having concluded that the criteria for
revocation of the Authorizations under
section 564(g)(2)(C) of the FD&C Act are
met, FDA has revoked the EUA of BioRad Laboratories Inc.’s Bio-Rad SARS–
CoV–2 ddPCR Kit, and Fast Track
Diagnostics Luxembourg S.á.r.l.’s (a
Siemens Healthineers Company) FTD
SARS–CoV–2. The revocations in their
entirety follow and provide an
explanation of the reasons for
revocation, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164–01–P
E:\FR\FM\17MYN1.SGM
17MYN1
Agencies
[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Notices]
[Pages 43407-43411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10838]
-----------------------------------------------------------------------
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
modifying an existing system of records maintained by the
Administration for Children and Families (ACF), Office of Child Support
Services (OCSS): System No. 09-80-0389, ``OCSE Data Center General
Support System,'' being renamed ``OCSS Data Exchange Platform.''
DATES: This Notice is applicable May 17, 2024, subject to a 30-day
period in which to comment on the new and revised routine uses,
described below. Please submit any comments by June 17, 2024.
ADDRESSES: The public should address written comments by mail or email
to: Anita Alford, Senior Official for Privacy, Administration for
Children and Families, 330 C St. SW, Washington, DC 20201, or by email
to [email protected].
FOR FURTHER INFORMATION CONTACT: General questions about these system
of records should be submitted by mail or email to Venkata Kondapolu,
Director, Division of Federal Systems, Office of Child Support
Services, at 330 C St. SW--5th Floor, Washington, DC 20201, or
[email protected], or by phone at 202-260-4712.
SUPPLEMENTARY INFORMATION:
I. Explanation of Changes to System of Records 09-80-0381
In accordance with 5 U.S.C. 552a(e)(4) and (11), HHS is modifying
an existing system of records maintained by ACF/OCSS: System No. 09-80-
0389, being renamed ``OCSS Data Exchange Platform.'' The system of
records covers records supporting State and Tribal child support
programs, and the program's external stakeholders, which are exchanged
electronically using a secure data exchange platform (the OCSS Data
Exchange Platform, or any successor system) provided by OCSS. The data
exchange platform facilitates electronic exchanges of information about
individual participants in child support cases, between State child
support agencies and other external partners such as employers, health
plan administrators, financial institutions, and central authorities in
foreign treaty countries or foreign countries that are the subject of a
declaration under 42 U.S.C. 659a. The child support agencies and other
external partners use the data exchange platform to electronically
submit information to and receive information from each other, through
OCSS.
The System of Records Notice (SORN) for system of records 09-80-
0389 has been modified as follows:
The system of records name has been changed to ``OCSS Data
Exchange Platform'' to reflect the name change of the ``Office of
Support Enforcement'' to the ``Office of Child Support Services'' and
to provide a more meaningful name for the system of records.
The System Manager(s) section has been revised to change
the office name to Office of Child Support Services.
The Purpose(s) section has been revised to describe the
system as a data exchange platform, rather than as a ``gateway
system,'' and one purpose, at the end of the section, has been expanded
to include the use of the data exchange platform by foreign authorities
to transmit case information associated with child support
disbursements transmitted from a foreign authority to the United States
through the Central Authority Payment (CAP) service.
The Categories of Records section has been revised to make
these changes to Category (4):
[cir] The phrase ``which includes'' has been changed to ``which may
include.''
[cir] Under (4)(c), ``agency's case number'' had been changed to
``agency's case identifier.''
[[Page 43408]]
The Record Source Categories section has been revised as
follows:
[cir] The description of State child support agencies transmitting
payment information to the CAP program has been modified to
``exchanging case-related information associated with child support
disbursements transmitted to foreign authorities through the CAP
service.''
[cir] An additional category has been added: ``[F]oreign
authorities exchanging case-related information associated with child
support disbursements transmitted to State child support agencies
through the CAP service.''
The Routine Uses section has been updated as follows:
[cir] The word ``enforcement'' has been removed from routine uses
1, 2, 4, and 6.
[cir] Routine use 11 has been revised to include disclosure of
information involving residents of foreign treaty countries or foreign
reciprocating countries to State child support programs for child
support purposes.
The Policies and Practices for Retention and Disposal of
Records section has been revised to include General Records Schedule
5.2, items 010 and 020 as the applicable disposition authority.
Venkata Kondapolu,
Director, Division of Federal Systems, Office of Child Support
Services, Administration for Children and Families, U.S. Department of
Health and Human Services.
SYSTEM NAME AND NUMBER:
OCSS Data Exchange Platform, 09-80-0389.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
Office of Child Support Services, Administration for Children and
Families, 330 C St. SW, 5th Floor, Washington, DC 20201.
SYSTEM MANAGER(S):
Director, Division of Federal Systems, Office of Child Support
Services, Administration for Children and Families, Department of
Health and Human Services, 330 C St. SW, 5th Floor, Washington, DC
20201, [email protected], 202-260-4712.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 652, 654, 654a, 654b, 659, 659a, 666, 669a.
PURPOSE(S) OF THE SYSTEM:
The purpose of the system of records is to cover records supporting
State and Tribal child support programs, and the programs' external
stakeholders, which are exchanged electronically using a secure data
exchange platform provided by OCSS. The platform facilitates electronic
exchanges of information about individual participants in child support
cases, between State child support agencies and other external partners
such as employers, health plan administrators, financial institutions,
and central authorities in foreign treaty countries or foreign
countries that are the subject of a declaration under 42 U.S.C. 659a.
The child support agencies and other external partners use the data
exchange platform to electronically submit information to and receive
information from each other, through OCSS.
The platform supports, for example:
The Electronic Income Withholding Order (e-IWO) program,
which provides the means to electronically exchange income withholding
order information between State child support agencies and employers.
The Electronic National Medical Support Notice (e-NMSN)
program, which allows State child support agencies, employers, and
health plan administrators to electronically send and receive National
Medical Support Notices used to enroll children in medical insurance
plans pursuant to child support orders.
The Federally Assisted State Transmitted (FAST) Levy
program, which allows States and financial institutions to exchange
information about levy actions through an electronic process.
The Central Authority Payment (CAP) service, which allows
States and foreign authorities to exchange details of child support
disbursements transmitted between the United States and the authorized
entity of the foreign treaty country or foreign country subject of a
declaration under 42 U.S.C. 659a for distribution of the support
payment by the foreign authority or the State child support agency in
accordance with the terms of the order.
Multiple child support program partners utilize the platform to
electronically send and receive information:
State child support agencies use the platform to transmit e-IWOs to
employers and e-NMSNs to employers and health plan administrators.
State child support agencies also use the platform to create levy
actions for distribution to multiple financial institutions, and to
transmit information about child support disbursements between U.S.
States and foreign authorities through the CAP service.
Employers use the platform to respond to State child support
agencies regarding e-IWOs and to provide information about health
insurance coverage provided by the employer. Employers and health plan
administrators use the platform to respond to State child support
agencies regarding e-NMSNs.
Financial institutions use the platform to receive and respond to
levy actions from multiple State child support agencies.
U.S. States and foreign authorities use the platform to transmit
case information associated with child support disbursements
transmitted between the United States and a foreign authority through
the CAP service.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The records in the system of records are about custodial and
noncustodial parents, legal guardians, and third-party caretakers who
are participants in child support program cases and whose names and
Social Security numbers (SSNs) are used to retrieve the records.
Children's personal identifiers are not used to retrieve records in
this system of records, so children are not subject individuals for
purposes of this system of records.
CATEGORIES OF RECORDS IN THE SYSTEM:
The categories of records exchanged in the platform include:
1. Child support case information used to populate an e-IWO, which
may include:
a. Name of State, Tribe, territory, or private individual entity
issuing an e-IWO;
b. Order ID and Case ID;
c. Remittance ID;
d. Employer/income withholder name, address, Federal employer
identification number (FEIN), telephone number, FAX number, email, or
website;
e. Employee/obligor's name, Social Security number (SSN), date of
birth;
f. Custodial parent's/obligee's name;
g. Child(ren)'s name(s) and date(s) of birth;
h. Income withholding amounts for current child support, past-due
child support, current cash medical support, past-due cash medical
support, current spousal support, past-due spousal support;
i. Child support State disbursement unit or Tribal order payee name
and address;
j. Judge/issuing official's name, title, and signature; and
k. Employee/obligor termination date, last known telephone number,
last
[[Page 43409]]
known address, new employer/income withholder's name and address.
2. Child support case information used to populate an e-NMSN, and
medical insurance information included in e-NMSN responses from
employers and health plan administrators, which may include:
a. Custodial parent/obligee's name and mailing address;
b. Substituted official/agency name and address (if custodial
parent/obligee's address is left blank);
c. Name, telephone number, and mailing address of representative of
child(ren);
d. Child(ren)'s name(s), gender, date of birth, and SSN;
e. Employee's name, SSN, and mailing address;
f. Plan administrator name, contact person, FAX number and
telephone number;
g. Employer and/or employer representative name, FEIN, and
telephone number;
h. Date of medical support termination, reason for termination, and
child(ren) to be terminated from medical support;
i. Medical insurance provider name, group number, policy number,
address;
j. Dental insurance provider name, group number, policy number,
address;
k. Vision insurance provider name, group number, policy number,
address;
l. Prescription drug insurance provider name, group number, policy
number, address;
m. Mental health insurance provider name, group number, policy
number, address;
n. Other insurance, specified by name, group number, policy number,
address; and
o. Plan administrator name, title, telephone number and address.
3. Child support case information used to administer the FAST Levy
program, which includes:
a. Requesting State agency name, address, and State Federal
Information Processing Standard (FIPS) code;
b. Financial institution's name and FEIN;
c. Obligor's name, SSN, and date of birth;
d. Account number of account from which to withhold funds;
e. Withholding amount; and
f. Contact name, phone number, and email for point of contact in
requesting State.
4. Child support case information used to administer the CAP
service, which may include:
a. Obligor/non-custodial parent's name and SSN;
b. Foreign authority name, FIPS locator code, and foreign
authority's child support case identifier;
c. U.S. State name and State child support agency's case
identifier;
d. Amount and date of payment;
e. Medical support indicator; and
f. Employment termination indicator.
RECORD SOURCE CATEGORIES:
The sources of the information in the system of records include:
State child support agencies initiating e-IWO, e-NMSN, and
FAST Levy program transactions in domestic child support cases and
exchanging case-related information associated with child support
disbursements transmitted to foreign authorities through the CAP
service.
Employers or authorized third parties responding to e-IWOs
and e-NMSNs.
Health plan administrators responding to e-NMSNs.
Financial institutions responding to FAST Levy requests.
Foreign authorities exchanging case-related information
associated with child support disbursements transmitted to State child
support agencies through the CAP service.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND PURPOSES OF SUCH USES:
In addition to the disclosures authorized directly in the Privacy
Act at 5 U.S.C. 552a(b)(1) and (b)(2) and (b)(4) through (b)(11), these
routine uses specify circumstances under which the agency may disclose
information from this system of records to a non-HHS officer or
employee without the consent of the data subject. ACF will prohibit
redisclosures, or may permit only certain redisclosures, as required or
authorized by law. Each proposed disclosure or redisclosure of
information permitted directly in the Privacy Act or under these
routine uses will be evaluated to ensure that the disclosure or
redisclosure is legally permissible.
Any information defined as ``return'' or ``return information''
under 26 U.S.C. 6103 (Internal Revenue Code) is not disclosed unless
authorized by a statute, the Internal Revenue Service (IRS), or IRS
regulations.
1. Disclosure to Financial Institution to Collect Past-Due Support.
Pursuant to 42 U.S.C. 652(l), information pertaining to an
individual owing past-due child support may be disclosed to a financial
institution doing business in two or more States to identify an
individual who maintains an account at the institution for the purpose
of collecting past-due support. Information pertaining to requests by
the State child support agencies for the placement of a lien or levy of
such accounts may also be disclosed.
2. Disclosure of Financial Institution Information to State Child
Support Agency for Assistance in Collecting Past-Due Support.
Pursuant to 42 U.S.C. 652(l), the results of a comparison between
information pertaining to an individual owing past-due child support
and information provided by multistate financial institutions may be
disclosed to a State child support agency for the purpose of assisting
the State agency in collecting past-due support. Information pertaining
to responses to requests by a State child support agency for the
placement of a lien or levy of such accounts may also be disclosed.
3. Disclosure to Employer to Enforce Child Support Obligations.
Pursuant to 42 U.S.C. 666(b), information pertaining to an
individual owing current or past-due child support may be disclosed to
an employer for the purpose of collecting current or past-due support
by way of an e-IWO.
4. Disclosure of Employer Information to State Child Support Agency
in Response to an e-IWO.
Information pertaining to a response by an employer to an e-IWO
issued by a State child support agency for the collection of child
support may be disclosed to the State child support agency.
5. Disclosure to Employer and Health Plan Administrator to Enforce
Medical Support Obligations.
Pursuant to 42 U.S.C. 666(a)(19), information pertaining to
participants in a child support case may be disclosed to an employer or
a health plan administrator for the purpose of enforcing medical
support for a child by way of an e-NMSN.
6. Disclosure of Employer and Health Plan Administrator Information
to State Child Support Agency in Response to an e-NMSN.
Information pertaining to a response by an employer or a health
plan administrator to an e-NMSN issued by a State child support agency
for the enforcement of medical support may be disclosed to the State
child support agency.
7. Disclosure to Department of Justice or in Proceedings.
Records may be disclosed to the Department of Justice (DOJ) or to a
court or other adjudicative body in litigation or other proceedings
when HHS or any of its components, or any employee of HHS acting in the
employee's official capacity, or any employee of HHS acting
[[Page 43410]]
in the employee's individual capacity where the DOJ or HHS has agreed
to represent the employee, or 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.
8. Disclosure to Congressional Office.
Information may be disclosed to a congressional office from the
record of an individual in response to a written inquiry from the
congressional office made at the written request of the individual.
9. Disclosure to Contractor to Perform Duties.
Records may be disclosed to a contractor performing or working on a
contract for HHS and who has a need to have access to the information
in the performance of its duties or activities for HHS in accordance
with law and with the contract.
10. Disclosure in the Event of a Security Breach.
a. Information may be disclosed 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's efforts to respond to the
suspected or confirmed breach or to prevent, minimize, or remedy such
harm.
b. Information may be disclosed 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.
11. Disclosure to a Foreign Reciprocating Country, Foreign Treaty
Country, and State Child Support Program for Child Support Purposes.
Pursuant to 42 U.S.C. 652(n), 653(a)(2), 653(c)(5) and 659a(c)(2),
child support case information involving residents of the United States
and residents of foreign treaty countries or foreign countries that are
the subject of a declaration under 42 U.S.C. 659a may be disclosed to
the foreign authority and to State child support programs.
POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
The records are stored electronically.
POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
Records are retrieved by the parent's, guardian's or third-party
caretaker's name or SSN.
POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
Because the platform is not a source system but facilitates access
to records from other systems which are the official sources of the
records, the records are retained and disposed of in accordance with
General Records Schedule 5.2 Transitory and Intermediary Records, Items
010 and 020 (DAA-GRS-2022-0009-0001 and DAA-GRS-2022-0009-0002), which
provides these disposition periods:
Item 010 Transitory records: Destroy when no longer needed
for business use, or according to an agency predetermined time period
or business rule.
Item 020 Intermediary records: Destroy upon creation or
update of the final record, or when no longer needed for business use,
whichever is later.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
The platform leverages cloud service providers that maintain an
authority to operate in accordance with applicable laws, rules, and
policies, including Federal Risk and Authorization Management Program
(FedRAMP) requirements. Specific administrative, technical, and
physical controls are in place to ensure that the records collected,
maintained, and transmitted using the platform are secure from
unauthorized access. Access to the records within the system is
restricted to authorized personnel who are advised of the
confidentiality of the records and the civil and criminal penalties for
misuse and who sign a nondisclosure oath to that effect. Agency
personnel are provided privacy and security training before being
granted access to the records and annually thereafter. Additional
safeguards include protecting the facilities where records are stored
or accessed with security guards, badges and cameras; limiting access
to electronic databases to authorized users based on roles and either
two-factor authentication or user ID and password (as appropriate);
using a secured operating system protected by encryption, firewalls,
and intrusion detection systems; reviewing security controls on a
periodic basis; and using secure destruction methods prescribed in NIST
SP 800-88 to dispose of eligible records. All safeguards conform to the
HHS Information Security and Privacy Program, https://www.hhs.gov/ocio/securityprivacy/.
RECORD ACCESS PROCEDURES:
To request access to a record about you in this system of records,
submit a written access request to the System Manager identified in the
``System Manager'' section of this System of Records Notice (SORN). The
request must reasonably describe the record sought and must include
(for contact purposes and identity verification purposes) your full
name, current address, telephone number and/or email address, date and
place of birth, and signature, and (if needed by the agency) sufficient
particulars contained in the records (such as, your SSN) to enable the
System Manager to distinguish between records on subject individuals
with the same name. In addition, to verify your identity, your
signature must be notarized, or the request must include your written
certification that you are the individual who you claim to be and that
you understand that the knowing and willful request for or acquisition
of a record pertaining to an individual under false pretenses is a
criminal offense subject to a fine of up to $5,000. You may request
that copies of the records be sent to you, or you may request an
appointment to review the records in person (including with a person of
your choosing, if you provide written authorization for agency
personnel to discuss the records in that person's presence). You may
also request an accounting of disclosures that have been made of
records about you, if any.
CONTESTING RECORD PROCEDURES:
To request correction of a record about you in this system of
records, submit a written amendment request to the System Manager
identified in the ``System Manager'' section of this SORN. The request
must contain the same information required for an access request and
include verification of your identity in the same manner required for
an access request. In addition, the request must reasonably identify
the record and specify the information contested, the corrective action
sought, and the reasons for requesting the correction; and should
include supporting information to show how the
[[Page 43411]]
record is inaccurate, incomplete, untimely, or irrelevant.
NOTIFICATION PROCEDURES:
To find out if the system of records contains a record about you,
submit a written notification request to the System Manager identified
in the ``System Manager'' section of this SORN. The request must
identify this system of records, contain the same information required
for an access request, and include verification of your identity in the
same manner required for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
87 FR 69026 (Nov. 17, 2022).
[FR Doc. 2024-10838 Filed 5-16-24; 8:45 am]
BILLING CODE 4184-42-P