Privacy Act of 1974; System of Records Notice, 21344-21347 [2019-09926]
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21344
Federal Register / Vol. 84, No. 93 / Tuesday, May 14, 2019 / Notices
biological product that is shown to meet
the standards described in section
351(k)(4), means that the biological
product may be substituted for the
reference product without the
intervention of the healthcare provider
who prescribed the reference product.
This guidance gives an overview of
important scientific considerations in
demonstrating interchangeability with a
reference product, including:
• The data and information
recommended to support a
demonstration of interchangeability
• Considerations for the design and
analysis of a switching study or studies
to support a demonstration of
interchangeability
• Considerations regarding the
comparator product in a switching
study or studies
• Abbreviated considerations for
developing presentations, container
closure systems, and delivery device
constituent parts for proposed
interchangeable products
This guidance finalizes the draft
guidance issued on January 18, 2017.
Changes made to the guidance took into
consideration the comments received.
FDA provided changes to clarify its
recommendations for demonstrating
interchangeability with the reference
product. FDA intends to provide more
detailed recommendations on the data
and information recommended to
support the proposed interchangeable
product’s presentation and related
issues in a separate guidance.
In the Federal Register of January 18,
2017 (82 FR 5579), FDA announced the
availability of the draft guidance for
industry ‘‘Considerations in
Demonstrating Interchangeability With a
Reference Product.’’ FDA requested
comment on the following questions: (1)
Are there considerations in addition to
comparability assessments that FDA
should consider in regulating postapproval manufacturing changes of
interchangeable products and (2) how, if
at all, should the Agency consider
conditions of use that are licensed for
the reference product after an
interchangeable product has been
licensed. The comments submitted in
response to these questions are being
considered; FDA will address these
topics in future guidance, as
appropriate.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Considerations in
Demonstrating Interchangeability With a
Reference Product.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
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use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information
under 21 CFR part 312 have been
approved under OMB control number
0910–0014; the collections of
information under 21 CFR part 601 have
been approved under OMB control
number 0910–0338; and the collections
of information under section 351(k) of
the PHS Act have been approved under
OMB control number 0910–0719.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: May 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10001 Filed 5–10–19; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Privacy Act of 1974; System of
Records Notice
Office of the Secretary of
Health and Human Services (OS),
Department of Health and Human
Services (HHS).
ACTION: Notice of a modified system of
records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended, HHS is revising a
department-wide system of records,
System No. 09–90–1601 titled Outside
Experts Recruited for Non-FACA
Activities, to add records about outside
consultants used by HHS’
Administration for Children and
Families, Office of Trafficking in
Persons (ACF/OTIP).
DATES: The modified system of records
is effective June 13, 2019, with the
exception of the new and revised
routine uses. The new and revised
SUMMARY:
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routine uses will be effective 30 days
after publication of this notice, unless
comments are received that warrant a
revision to this notice. Comments
should be submitted within 30 days of
publication, but may be made at any
time.
ADDRESSES: The public should submit
written comments by mail or email to
Beth Kramer, HHS Privacy Act Officer,
FOIA/PA Division, Hubert H.
Humphrey Bldg., Ste. 729H, 200
Independence Ave. SW, Washington,
DC 20201, or beth.kramer@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
General questions about the modified
system of records may be submitted by
mail or email to Beth Kramer, HHS
Privacy Act Officer, FOIA/PA Division,
Hubert H. Humphrey Bldg., Ste. 729H,
200 Independence Ave. SW,
Washington, DC 20201, or beth.kramer@
hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Explanation of Modifications Made to
System No. 09–90–1601
This department-wide system of
records covers records about individuals
outside the HHS workforce who serve or
are considered for service on missionrelated committees and other activities
(such as peer review programs) which
require specific expertise or experience
but are not subject to the Federal
Advisory Committee Act (FACA), 5
U.S.C. App., et seq. The system of
records has been modified to add the
following records maintained by the
Administration for Children and
Families’ Office on Trafficking in
Persons (ACF/OTIP):
• Consultants on Office on
Trafficking in Persons (OTIP) projects.
ACF/OTIP contractors arrange for
outside consultants to be used in OTIP
programs (in addition to peer review
programs) when technical assistance is
needed in conferences, meetings, and
evaluation projects that involve a
specialized area of research, review, or
advice.
The ACF/OTIP consultant records are
similar in type and function to the other
records currently covered by System No.
09–90–1601; i.e.,:
• Curricula Vitae of Consultants to
the National Center for Health Statistics
(NCHS) within the Centers for Disease
Control and Prevention (CDC/NCHS)
(formerly covered under SORN 09–20–
0168). This program maintains records
about individuals with special
expertise, training, and professional
experience who may be enlisted to
assist CDC/NCHS as consultants. The
records are used by CDC/NCHS to select
individuals to participate in
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assignments such as: Planning and
conducting surveys, studies, statistical
reporting programs, and statistical
analyses of data; providing training and
technical assistance; and planning and
conducting conferences.
• The Food and Drug Administration
(FDA) Patient Representative Program.
This program enlists individuals with
patient advocacy experience to serve as
patient representatives on both FACA
committees and non-FACA assignments.
For example, patient representatives
may provide input that is used in
making decisions to approve devices or
drugs, or may contribute to discussions
at presentations and conferences.
Records about patient representatives
are retrieved by the representatives’
names, and are covered under either
SORN No. 09–90–0059 or SORN No.
09–90–1601, depending on whether the
records pertain to service on a FACA
committee or service on a non-FACA
assignment.
• Peer Review Programs at the
Administration for Children and
Families (ACF), Health Resources and
Services Administration (HRSA), and
Substance Abuse and Mental Health
Services Administration (SAMHSA) that
recruit and use outside individuals to
serve on peer review committees formed
to review applications for grants and
cooperative agreements. These programs
exist in several HHS components, but
only ACF, HRSA, and SAMHSA
sometimes use a personal identifier (i.e.,
name) to retrieve administrative records
about the outside individuals they
recruit and use. Other components
(including the Office of the Assistant
Secretary for Health (OASH), Centers for
Medicare & Medicaid Services (CMS),
and National Institutes of Health (NIH))
use only non-personal identifiers (e.g.,
expertise type, or funding opportunity
announcement number) for retrieval.
• Consultants on Other SAMHSA
Projects. SAMHSA contractors arrange
for outside consultants to be used in
other SAMHSA programs (besides peer
review programs) when technical
assistance is needed in conferences,
meetings, and evaluation projects that
involve a specialized area of research,
review, or advice.
The System of Records Notice (SORN)
for System No. 09–90–1601 has been
reformatted to comply with OMB
Circular A–108, issued December 23,
2016, and has been revised as follows to
cover ACF/OTIP consultant records:
• The System Manager(s) section and
Records Location section have been
updated to identify the component
responsible for ACF/OTIP consultant
records.
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• The Authority section now includes
the legal authorities applicable to ACF/
OTIP consultant records.
• The Categories of Individuals
section has been revised to add ‘‘human
trafficking’’ to the list of examples of
outside experts’ areas of expertise or
experience.
• In the Categories of Records section,
‘‘[d]ates and descriptions of current
assignments’’ has been added to the list
of data elements that may be contained
in the records.
• Routine use 7 has been revised to
remove the following unnecessary
wording: ‘‘and that, therefore, the use of
such records by the DOJ, court or other
tribunal is deemed by HHS to be
compatible with the purpose for which
the agency collected the records.’’ The
wording is unnecessary because a
routine use is defined in subsection
(a)(7) of the Privacy Act as a disclosure
of a record for a use that is compatible
with the purpose for which the record
was collected.
Because some of these revisions are
significant, a report on the modified
system of records was sent to Congress
and OMB in accordance with 5 U.S.C.
552a(r).
Dated: May 8, 2019.
Michael S. Marquis,
Director, FOIA/Privacy Act Division,
Assistant Secretary for Public Affairs.
Dated: May 8, 2019.
Anita E. Alford,
Chief Information Security Officer and OpDiv
Senior Officer for Privacy, Office of the Chief
Information Officer, Administration for
Children and Families.
SYSTEM NAME AND NUMBER
Outside Experts Recruited for NonFACA Activities, 09–90–1601.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of each agency
component responsible for the system of
records is provided in the System
Manager(s) section. Records locations
include:
D CDC program offices that recruit
consultants to assist in statistical
projects and reporting programs
conducted or sponsored by NCHS, in
Atlanta, GA and Hyattsville, MD;
D FDA’s committee management
office in Silver Spring, MD;
D Program offices at ACF in
Washington, DC, at HRSA in Rockville,
MD, and at SAMHSA in Rockville, MD,
that recruit individuals to serve as peer
reviewers; and
D Locations of SAMHSA contractors
that arrange use of consultants on
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SAMHSA projects, and locations of
ACF/OTIP contractors that arrange use
of consultants on OTIP projects.
SYSTEM MANAGER(S):
For CDC/NCHS Consultant Records:
Centers for Disease Control and
Prevention (CDC), Director, National
Center for Health Statistics, OPHSS,
Prince George’s Metro IV Bldg., Rm.
7209, MS P08, 3311 Toledo Rd.,
Hyattsville, MD 20782, (301) 458–4000.
For FDA Patient Representative
Records: Food and Drug Administration
(FDA), Advisory Committee Oversight &
Management Staff, 10903 New
Hampshire Ave., Bldg. WO32, Rm.
5129, Silver Spring, MD 20993–002,
(301) 443–0572.
For ACF Peer Reviewer Records:
Administration for Children and
Families (ACF), Privacy Act Contact,
Office of the Chief Information Officer,
330 C St. SW, Washington, DC 20201,
OCIO.Privacy@acf.hhs.gov, (202) 401–
4628.
For HRSA Peer Reviewer Records:
Health Resources and Services
Administration (HRSA), Chief, Policy,
Analysis & Training Branch, Division of
Independent Review, Office of Federal
Assistance Management, 5600 Fishers
Ln., Rockville, MD 20857, (301) 443–
4767.
For SAMHSA Peer Reviewer Records:
Substance Abuse and Mental Health
Services Administration (SAMHSA),
Director, Division of Grant Review, 5600
Fishers Ln., Rockville, MD 20852, (240)
276–1199.
For Other Consultant Records,
Maintained by SAMHSA Contractors:
Substance Abuse and Mental Health
Services Administration (SAMHSA),
Director, Division of Contracts
Management, Office of Program
Services, 5600 Fishers Ln., Rockville,
MD 20852, (240) 276–1500.
For Other Consultant Records,
Maintained by ACF/OTIP Contractors:
Office on Trafficking in Persons (OTIP),
Deputy Director, Mary E. Switzer
Building, 330 C St. SW, Washington, DC
20201, (202) 401–9372.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
For CDC/NCHS Consultant Records:
42 U.S.C. 242b(b)(3).
For FDA Patient Representative
Records: 21 U.S.C. 360bbb–8c, 371 et
seq., 379d–1(b)(1)(A).
For ACF Peer Reviewer Records: 42
U.S.C. 799(f), 806(e).
For HRSA Peer Reviewer Records: 42
U.S.C. 799(f), 806(e).
For SAMHSA Peer Reviewer and
Other Consultant Records: 42 U.S.C.
241, 249(c), 290aa et seq., 290aa–5,
290bb et seq., 290bb–21 et seq., 290bb–
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31 et seq., 5121 et seq., 10801 et seq.;
8 U.S.C. 1522 note; Executive Order
12341.
For OTIP Consultant Records: 22
U.S.C. 7104(b), 7105(b)(1)(G), (c)(4), and
(f); 42 U.S.C. 1314b.
See also: 5 U.S.C. 3109.
PURPOSE(S):
The records are used within the
agency on a need-to-know basis for the
purpose of staffing committees and
other assignments and managing
administrative matters pertaining to
individuals serving on committees and
other assignments, including to:
• Prepare reports and lists of past,
present, and recommended members,
vacancies, acceptances, and separations;
• Send recruitment notices to
individual prospective candidates, and
send informational notices to selectees;
• Identify qualified candidates and
document the selections; and
• Manage and coordinate the selected
individuals’ participation in assignment
activities (including sharing information
within the agency to coordinate aspects
such as badging, parking, travel,
training, and payment of any stipend or
honorarium).
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
Records in this system pertain to
individuals outside the HHS workforce
who serve or are considered for service
on HHS mission-related committees or
other assignments that require specific
outside expertise or experience (for
example, medical, scientific,
manufacturing, or human trafficking
expertise, or patient advocacy
experience), but that are not subject to
the Federal Advisory Committee Act
(FACA), 5 U.S.C. App., et seq.
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CATEGORIES OF RECORDS IN THE SYSTEM:
The records consist of recruitment
and other administrative records,
including:
• An application and resume or
curricula vitae, describing the
individual’s qualifications;
• Nomination/recommendation
records, or other records used in
evaluating an individual’s qualifications
and any potential conflicts of interest
and selecting an individual for a
specific assignment; and
• Records used to plan and arrange
the individual’s participation in the
assigned activities, including
scheduling records and records used to
coordinate parking, badging, and
payment of any stipend or honorarium.
The records may contain these data
elements:
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• The individual’s name and other
identifying information (e.g., sex, place
and date of birth);
• Contact information (e.g., home and
business addresses, telephone numbers,
email addresses);
• Occupation, job titles, employers,
employment status and history, and
whether currently employed by the
federal government;
• Work and organizational
affiliations, memberships, credentials,
and licenses;
• Degrees held, and general
educational and/or experience
background;
• Racial classification or ethnic
background;
• Areas of specialization, expertise, or
experience, and special qualifications
(e.g., language or technical skills, ability
to drive to an assignment);
• Dates and descriptions of past
assignments or past experience;
• Dates and descriptions of current
assignments;
• Sources and references, and any
information provided by sources/
references; and
• Information about availability and
any special needs.
Any special needs, medical condition,
or similar information contained in an
individual’s records is maintained and
used in accordance with relevant
provisions of the Rehabilitation Act of
1973, as amended, 29 U.S.C. 791 et seq.,
and implementing regulations at 29 CFR
parts 1614 and 1630, and the Genetic
Information Nondiscrimination Act of
2008 at 42 U.S.C. 2000ff et seq.
RECORD SOURCE CATEGORIES:
Most information is obtained directly
from the individual record subject.
Information pertaining to references and
recommendations is obtained from other
private individuals, educational
institutions, current and former
employers, HHS program personnel,
biographical reference books, private
organizations, members of Congress,
and other government sources.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:
HHS may make the following
disclosures of information about an
individual record subject from this
system of records to parties outside the
agency without the individual’s prior,
written consent:
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 and that have a need to have
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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 parties
such as educational institutions, current
and former employers, and qualified
experts, when necessary to check or
obtain an opinion about a candidate’s
qualifications.
3. Records about consultants and
patient advocates may be disclosed to
parties organizing or hosting assignment
activities, such as grantee institutions
and federal, foreign, state, tribal, local,
and other government agencies and
public authorities (e.g., U.S. Embassies
and Ministries of Health), when
necessary to apprise them of an
individual’s qualifications for the
assignment or coordinate the
individual’s participation in the
activities.
4. Records may be disclosed to
supervisors and administrative
assistants at the individual’s place of
employment, for administrative
purposes such as coordinating the
individual’s participation in the
activities.
5. Records may be disclosed to
external parties that audit committee or
assignment activities.
6. Relevant information will be
included in any required reports to the
President, the Office of Management
and Budget (OMB), and the General
Services Administration (GSA) about
committees and other assignments that
are mission-related.
7. Information may be disclosed to the
U.S. Department of Justice (DOJ) or to a
court or other tribunal, when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where DOJ
has agreed to represent the employee, or
d. The United States Government, is
a party to litigation or has an interest in
such litigation and, by careful review,
HHS determines that the records are
both relevant and necessary to the
litigation.
8. Records may be disclosed to
student volunteers and other
individuals performing functions 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.
9. Disclosures may be made to the
National Archives and Records
Administration (NARA) and/or the
General Services Administration (GSA)
for the purpose of records management
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inspections conducted under 44 U.S.C.
2904 and 2906.
10. Information may be disclosed to a
Member of Congress or a 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.
11. 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.
12. Records 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.
13. Records 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.
The disclosures authorized by
publication of the above routine uses
pursuant to 5 U.S.C. 552a(b)(3) are in
addition to other disclosures authorized
directly in the Privacy Act at 5 U.S.C.
552a(b)(4)–(11).
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
Records are stored in hard-copy files
and electronic media.
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
Records are retrieved by the
individual’s name.
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POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
Records pertaining to recruitment and
use of outside peer reviewers are
destroyed three years after final action;
they are retained longer if required for
business use (see General Records
Schedule (GRS) 1.2, Item 010, Grant and
Cooperative Agreement Program
Management Records). Records
pertaining to recruitment and use of
other outside individuals (e.g., experts,
patient advocates, and members of
mission-related non-FACA committees)
are currently unscheduled.
Unscheduled records must be retained
indefinitely pending the agency’s
submission, and NARA’s approval, of a
disposition schedule. HHS anticipates
proposing to NARA, as an appropriate
retention period for these records,
‘‘three years after final action, or longer
if required for business use’’ (similar to
the period provided in GRS 1.2, Item
010) or ‘‘when no longer needed for
administrative purposes’’ (similar to the
periods applicable to similar records not
retrieved by personal identifier which
are not covered under this SORN; i.e.:
N1–442–93–1, Item 37 for the Agency
for Toxic Substances and Disease
Registry’s Curriculum Vitae Files, and
NC1–235–82–1, Item 100–3 for the
Office of the Secretary’s Advisory
Committee Candidate Resume Files).
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
Safeguards conform to the HHS
Information Security and Privacy
Program, https://www.hhs.gov/ocio/
securityprivacy/. Information
is safeguarded in accordance with
applicable laws, rules and policies,
including the HHS Information
Technology Security Program
Handbook, all pertinent National
Institutes of Standards and Technology
(NIST) publications, and OMB Circular
A–130, Managing Information As a
Strategic Resource. Records are
protected from unauthorized access
through appropriate administrative,
physical, and technical safeguards.
These 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
two-factor authentication (user ID and
password), using a secured operating
system protected by encryption,
firewalls, and intrusion detection
systems, requiring encryption for
records stored on removable media, and
training personnel in Privacy Act and
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information security requirements.
Records that are eligible for destruction
are disposed of using destruction
methods prescribed by NIST SP 800–88.
RECORD ACCESS PROCEDURES:
An individual seeking access to
records about him or her in this system
should submit a written request to the
relevant System Manager indicated in
the ‘‘System Manager(s)’’ section above.
The requester must verify his or her
identity by providing either a
notarization of the request or a written
certification that the requester is who he
or she claims to be and understands that
the knowing and willful request for
acquisition of a record pertaining to an
individual under false pretenses is a
criminal offense under the Privacy Act,
subject to a five thousand dollar fine.
CONTESTING RECORD PROCEDURES:
An individual seeking to amend a
record about him or her in this system
should contact the relevant System
Manager indicated in the ‘‘Section
Manager(s)’’ section, verify his or her
identity in the manner indicated in the
‘‘Record Access Procedures’’ section,
and reasonably identify the record,
specify the information contested, state
the corrective action sought, and
provide the reasons for the amendment,
with any supporting documentation.
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system contains records about him
or her should contact the relevant
System Manager indicated in the
‘‘Section Manager(s)’’ section and verify
his or her identity in the manner
indicated in the ‘‘Record Access
Procedures’’ section.
EXEMPTIONS CLAIMED FOR THE SYSTEM:
None.
HISTORY:
81 FR 83246 (Nov. 21, 2016), 83 FR
6591 (Feb. 14, 2018).
[FR Doc. 2019–09926 Filed 5–13–19; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Meeting of the
National Clinical Care Commission
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The National Clinical Care
Commission (the Commission) will
SUMMARY:
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[Federal Register Volume 84, Number 93 (Tuesday, May 14, 2019)]
[Notices]
[Pages 21344-21347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09926]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Privacy Act of 1974; System of Records Notice
AGENCY: Office of the Secretary of Health and Human Services (OS),
Department of Health and Human Services (HHS).
ACTION: Notice of a modified system of records.
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, as amended, HHS is revising a department-wide system of records,
System No. 09-90-1601 titled Outside Experts Recruited for Non-FACA
Activities, to add records about outside consultants used by HHS'
Administration for Children and Families, Office of Trafficking in
Persons (ACF/OTIP).
DATES: The modified system of records is effective June 13, 2019, with
the exception of the new and revised routine uses. The new and revised
routine uses will be effective 30 days after publication of this
notice, unless comments are received that warrant a revision to this
notice. Comments should be submitted within 30 days of publication, but
may be made at any time.
ADDRESSES: The public should submit written comments by mail or email
to Beth Kramer, HHS Privacy Act Officer, FOIA/PA Division, Hubert H.
Humphrey Bldg., Ste. 729H, 200 Independence Ave. SW, Washington, DC
20201, or [email protected].
FOR FURTHER INFORMATION CONTACT: General questions about the modified
system of records may be submitted by mail or email to Beth Kramer, HHS
Privacy Act Officer, FOIA/PA Division, Hubert H. Humphrey Bldg., Ste.
729H, 200 Independence Ave. SW, Washington, DC 20201, or
[email protected].
SUPPLEMENTARY INFORMATION:
I. Explanation of Modifications Made to System No. 09-90-1601
This department-wide system of records covers records about
individuals outside the HHS workforce who serve or are considered for
service on mission-related committees and other activities (such as
peer review programs) which require specific expertise or experience
but are not subject to the Federal Advisory Committee Act (FACA), 5
U.S.C. App., et seq. The system of records has been modified to add the
following records maintained by the Administration for Children and
Families' Office on Trafficking in Persons (ACF/OTIP):
Consultants on Office on Trafficking in Persons (OTIP)
projects. ACF/OTIP contractors arrange for outside consultants to be
used in OTIP programs (in addition to peer review programs) when
technical assistance is needed in conferences, meetings, and evaluation
projects that involve a specialized area of research, review, or
advice.
The ACF/OTIP consultant records are similar in type and function to
the other records currently covered by System No. 09-90-1601; i.e.,:
Curricula Vitae of Consultants to the National Center for
Health Statistics (NCHS) within the Centers for Disease Control and
Prevention (CDC/NCHS) (formerly covered under SORN 09-20-0168). This
program maintains records about individuals with special expertise,
training, and professional experience who may be enlisted to assist
CDC/NCHS as consultants. The records are used by CDC/NCHS to select
individuals to participate in
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assignments such as: Planning and conducting surveys, studies,
statistical reporting programs, and statistical analyses of data;
providing training and technical assistance; and planning and
conducting conferences.
The Food and Drug Administration (FDA) Patient
Representative Program. This program enlists individuals with patient
advocacy experience to serve as patient representatives on both FACA
committees and non-FACA assignments. For example, patient
representatives may provide input that is used in making decisions to
approve devices or drugs, or may contribute to discussions at
presentations and conferences. Records about patient representatives
are retrieved by the representatives' names, and are covered under
either SORN No. 09-90-0059 or SORN No. 09-90-1601, depending on whether
the records pertain to service on a FACA committee or service on a non-
FACA assignment.
Peer Review Programs at the Administration for Children
and Families (ACF), Health Resources and Services Administration
(HRSA), and Substance Abuse and Mental Health Services Administration
(SAMHSA) that recruit and use outside individuals to serve on peer
review committees formed to review applications for grants and
cooperative agreements. These programs exist in several HHS components,
but only ACF, HRSA, and SAMHSA sometimes use a personal identifier
(i.e., name) to retrieve administrative records about the outside
individuals they recruit and use. Other components (including the
Office of the Assistant Secretary for Health (OASH), Centers for
Medicare & Medicaid Services (CMS), and National Institutes of Health
(NIH)) use only non-personal identifiers (e.g., expertise type, or
funding opportunity announcement number) for retrieval.
Consultants on Other SAMHSA Projects. SAMHSA contractors
arrange for outside consultants to be used in other SAMHSA programs
(besides peer review programs) when technical assistance is needed in
conferences, meetings, and evaluation projects that involve a
specialized area of research, review, or advice.
The System of Records Notice (SORN) for System No. 09-90-1601 has
been reformatted to comply with OMB Circular A-108, issued December 23,
2016, and has been revised as follows to cover ACF/OTIP consultant
records:
The System Manager(s) section and Records Location section
have been updated to identify the component responsible for ACF/OTIP
consultant records.
The Authority section now includes the legal authorities
applicable to ACF/OTIP consultant records.
The Categories of Individuals section has been revised to
add ``human trafficking'' to the list of examples of outside experts'
areas of expertise or experience.
In the Categories of Records section, ``[d]ates and
descriptions of current assignments'' has been added to the list of
data elements that may be contained in the records.
Routine use 7 has been revised to remove the following
unnecessary wording: ``and that, therefore, the use of such records by
the DOJ, court or other tribunal is deemed by HHS to be compatible with
the purpose for which the agency collected the records.'' The wording
is unnecessary because a routine use is defined in subsection (a)(7) of
the Privacy Act as a disclosure of a record for a use that is
compatible with the purpose for which the record was collected.
Because some of these revisions are significant, a report on the
modified system of records was sent to Congress and OMB in accordance
with 5 U.S.C. 552a(r).
Dated: May 8, 2019.
Michael S. Marquis,
Director, FOIA/Privacy Act Division, Assistant Secretary for Public
Affairs.
Dated: May 8, 2019.
Anita E. Alford,
Chief Information Security Officer and OpDiv Senior Officer for
Privacy, Office of the Chief Information Officer, Administration for
Children and Families.
SYSTEM NAME AND NUMBER
Outside Experts Recruited for Non-FACA Activities, 09-90-1601.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of each agency component responsible for the system of
records is provided in the System Manager(s) section. Records locations
include:
[ssquf] CDC program offices that recruit consultants to assist in
statistical projects and reporting programs conducted or sponsored by
NCHS, in Atlanta, GA and Hyattsville, MD;
[ssquf] FDA's committee management office in Silver Spring, MD;
[ssquf] Program offices at ACF in Washington, DC, at HRSA in
Rockville, MD, and at SAMHSA in Rockville, MD, that recruit individuals
to serve as peer reviewers; and
[ssquf] Locations of SAMHSA contractors that arrange use of
consultants on SAMHSA projects, and locations of ACF/OTIP contractors
that arrange use of consultants on OTIP projects.
SYSTEM MANAGER(S):
For CDC/NCHS Consultant Records: Centers for Disease Control and
Prevention (CDC), Director, National Center for Health Statistics,
OPHSS, Prince George's Metro IV Bldg., Rm. 7209, MS P08, 3311 Toledo
Rd., Hyattsville, MD 20782, (301) 458-4000.
For FDA Patient Representative Records: Food and Drug
Administration (FDA), Advisory Committee Oversight & Management Staff,
10903 New Hampshire Ave., Bldg. WO32, Rm. 5129, Silver Spring, MD
20993-002, (301) 443-0572.
For ACF Peer Reviewer Records: Administration for Children and
Families (ACF), Privacy Act Contact, Office of the Chief Information
Officer, 330 C St. SW, Washington, DC 20201, [email protected],
(202) 401-4628.
For HRSA Peer Reviewer Records: Health Resources and Services
Administration (HRSA), Chief, Policy, Analysis & Training Branch,
Division of Independent Review, Office of Federal Assistance
Management, 5600 Fishers Ln., Rockville, MD 20857, (301) 443-4767.
For SAMHSA Peer Reviewer Records: Substance Abuse and Mental Health
Services Administration (SAMHSA), Director, Division of Grant Review,
5600 Fishers Ln., Rockville, MD 20852, (240) 276-1199.
For Other Consultant Records, Maintained by SAMHSA Contractors:
Substance Abuse and Mental Health Services Administration (SAMHSA),
Director, Division of Contracts Management, Office of Program Services,
5600 Fishers Ln., Rockville, MD 20852, (240) 276-1500.
For Other Consultant Records, Maintained by ACF/OTIP Contractors:
Office on Trafficking in Persons (OTIP), Deputy Director, Mary E.
Switzer Building, 330 C St. SW, Washington, DC 20201, (202) 401-9372.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
For CDC/NCHS Consultant Records: 42 U.S.C. 242b(b)(3).
For FDA Patient Representative Records: 21 U.S.C. 360bbb-8c, 371 et
seq., 379d-1(b)(1)(A).
For ACF Peer Reviewer Records: 42 U.S.C. 799(f), 806(e).
For HRSA Peer Reviewer Records: 42 U.S.C. 799(f), 806(e).
For SAMHSA Peer Reviewer and Other Consultant Records: 42 U.S.C.
241, 249(c), 290aa et seq., 290aa-5, 290bb et seq., 290bb-21 et seq.,
290bb-
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31 et seq., 5121 et seq., 10801 et seq.; 8 U.S.C. 1522 note; Executive
Order 12341.
For OTIP Consultant Records: 22 U.S.C. 7104(b), 7105(b)(1)(G),
(c)(4), and (f); 42 U.S.C. 1314b.
See also: 5 U.S.C. 3109.
PURPOSE(S):
The records are used within the agency on a need-to-know basis for
the purpose of staffing committees and other assignments and managing
administrative matters pertaining to individuals serving on committees
and other assignments, including to:
Prepare reports and lists of past, present, and
recommended members, vacancies, acceptances, and separations;
Send recruitment notices to individual prospective
candidates, and send informational notices to selectees;
Identify qualified candidates and document the selections;
and
Manage and coordinate the selected individuals'
participation in assignment activities (including sharing information
within the agency to coordinate aspects such as badging, parking,
travel, training, and payment of any stipend or honorarium).
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Records in this system pertain to individuals outside the HHS
workforce who serve or are considered for service on HHS mission-
related committees or other assignments that require specific outside
expertise or experience (for example, medical, scientific,
manufacturing, or human trafficking expertise, or patient advocacy
experience), but that are not subject to the Federal Advisory Committee
Act (FACA), 5 U.S.C. App., et seq.
CATEGORIES OF RECORDS IN THE SYSTEM:
The records consist of recruitment and other administrative
records, including:
An application and resume or curricula vitae, describing
the individual's qualifications;
Nomination/recommendation records, or other records used
in evaluating an individual's qualifications and any potential
conflicts of interest and selecting an individual for a specific
assignment; and
Records used to plan and arrange the individual's
participation in the assigned activities, including scheduling records
and records used to coordinate parking, badging, and payment of any
stipend or honorarium.
The records may contain these data elements:
The individual's name and other identifying information
(e.g., sex, place and date of birth);
Contact information (e.g., home and business addresses,
telephone numbers, email addresses);
Occupation, job titles, employers, employment status and
history, and whether currently employed by the federal government;
Work and organizational affiliations, memberships,
credentials, and licenses;
Degrees held, and general educational and/or experience
background;
Racial classification or ethnic background;
Areas of specialization, expertise, or experience, and
special qualifications (e.g., language or technical skills, ability to
drive to an assignment);
Dates and descriptions of past assignments or past
experience;
Dates and descriptions of current assignments;
Sources and references, and any information provided by
sources/references; and
Information about availability and any special needs.
Any special needs, medical condition, or similar information
contained in an individual's records is maintained and used in
accordance with relevant provisions of the Rehabilitation Act of 1973,
as amended, 29 U.S.C. 791 et seq., and implementing regulations at 29
CFR parts 1614 and 1630, and the Genetic Information Nondiscrimination
Act of 2008 at 42 U.S.C. 2000ff et seq.
RECORD SOURCE CATEGORIES:
Most information is obtained directly from the individual record
subject. Information pertaining to references and recommendations is
obtained from other private individuals, educational institutions,
current and former employers, HHS program personnel, biographical
reference books, private organizations, members of Congress, and other
government sources.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
HHS may make the following disclosures of information about an
individual record subject from this system of records to parties
outside the agency without the individual's prior, written consent:
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
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 parties such as educational
institutions, current and former employers, and qualified experts, when
necessary to check or obtain an opinion about a candidate's
qualifications.
3. Records about consultants and patient advocates may be disclosed
to parties organizing or hosting assignment activities, such as grantee
institutions and federal, foreign, state, tribal, local, and other
government agencies and public authorities (e.g., U.S. Embassies and
Ministries of Health), when necessary to apprise them of an
individual's qualifications for the assignment or coordinate the
individual's participation in the activities.
4. Records may be disclosed to supervisors and administrative
assistants at the individual's place of employment, for administrative
purposes such as coordinating the individual's participation in the
activities.
5. Records may be disclosed to external parties that audit
committee or assignment activities.
6. Relevant information will be included in any required reports to
the President, the Office of Management and Budget (OMB), and the
General Services Administration (GSA) about committees and other
assignments that are mission-related.
7. Information may be disclosed to the U.S. Department of Justice
(DOJ) or to a court or other tribunal, when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where DOJ has agreed to represent the employee, or
d. The United States Government, is a party to litigation or has an
interest in such litigation and, by careful review, HHS determines that
the records are both relevant and necessary to the litigation.
8. Records may be disclosed to student volunteers and other
individuals performing functions 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.
9. Disclosures may be made to the National Archives and Records
Administration (NARA) and/or the General Services Administration (GSA)
for the purpose of records management
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inspections conducted under 44 U.S.C. 2904 and 2906.
10. Information may be disclosed to a Member of Congress or a
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.
11. 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.
12. Records 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.
13. Records 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.
The disclosures authorized by publication of the above routine uses
pursuant to 5 U.S.C. 552a(b)(3) are in addition to other disclosures
authorized directly in the Privacy Act at 5 U.S.C. 552a(b)(4)-(11).
POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
Records are stored in hard-copy files and electronic media.
POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
Records are retrieved by the individual's name.
POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
Records pertaining to recruitment and use of outside peer reviewers
are destroyed three years after final action; they are retained longer
if required for business use (see General Records Schedule (GRS) 1.2,
Item 010, Grant and Cooperative Agreement Program Management Records).
Records pertaining to recruitment and use of other outside individuals
(e.g., experts, patient advocates, and members of mission-related non-
FACA committees) are currently unscheduled. Unscheduled records must be
retained indefinitely pending the agency's submission, and NARA's
approval, of a disposition schedule. HHS anticipates proposing to NARA,
as an appropriate retention period for these records, ``three years
after final action, or longer if required for business use'' (similar
to the period provided in GRS 1.2, Item 010) or ``when no longer needed
for administrative purposes'' (similar to the periods applicable to
similar records not retrieved by personal identifier which are not
covered under this SORN; i.e.: N1-442-93-1, Item 37 for the Agency for
Toxic Substances and Disease Registry's Curriculum Vitae Files, and
NC1-235-82-1, Item 100-3 for the Office of the Secretary's Advisory
Committee Candidate Resume Files).
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
Safeguards conform to the HHS Information Security and Privacy
Program, https://www.hhs.gov/ocio/securityprivacy/.
Information is safeguarded in accordance with applicable laws, rules
and policies, including the HHS Information Technology Security Program
Handbook, all pertinent National Institutes of Standards and Technology
(NIST) publications, and OMB Circular A-130, Managing Information As a
Strategic Resource. Records are protected from unauthorized access
through appropriate administrative, physical, and technical safeguards.
These 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 two-factor authentication (user ID and
password), using a secured operating system protected by encryption,
firewalls, and intrusion detection systems, requiring encryption for
records stored on removable media, and training personnel in Privacy
Act and information security requirements. Records that are eligible
for destruction are disposed of using destruction methods prescribed by
NIST SP 800-88.
RECORD ACCESS PROCEDURES:
An individual seeking access to records about him or her in this
system should submit a written request to the relevant System Manager
indicated in the ``System Manager(s)'' section above. The requester
must verify his or her identity by providing either a notarization of
the request or a written certification that the requester is who he or
she claims to be and understands that the knowing and willful request
for acquisition of a record pertaining to an individual under false
pretenses is a criminal offense under the Privacy Act, subject to a
five thousand dollar fine.
CONTESTING RECORD PROCEDURES:
An individual seeking to amend a record about him or her in this
system should contact the relevant System Manager indicated in the
``Section Manager(s)'' section, verify his or her identity in the
manner indicated in the ``Record Access Procedures'' section, and
reasonably identify the record, specify the information contested,
state the corrective action sought, and provide the reasons for the
amendment, with any supporting documentation.
NOTIFICATION PROCEDURES:
An individual who wishes to know if this system contains records
about him or her should contact the relevant System Manager indicated
in the ``Section Manager(s)'' section and verify his or her identity in
the manner indicated in the ``Record Access Procedures'' section.
EXEMPTIONS CLAIMED FOR THE SYSTEM:
None.
HISTORY:
81 FR 83246 (Nov. 21, 2016), 83 FR 6591 (Feb. 14, 2018).
[FR Doc. 2019-09926 Filed 5-13-19; 8:45 am]
BILLING CODE 4184-01-P