Privacy Act of 1974; System of Records, 105054-105059 [2024-30782]
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105054
Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices
Division of Regulatory Operations for
Pain, Anesthesia, and Addiction
Medicine (DCDGLI)
Office of Program Operations (DCDGM)
Executive Operations Staff (DCDGM1)
Business Process & Analysis Staff
(DCDGM2)
Learning & Talent Development Staff
(DCDGM3)
Program Development, Implementation
& Management Staff (DCDGM4)
Office of Drug Evaluation Science
(DCDGN)
Division of Clinical Outcome
Assessment (DCDGNA)
Division of Biomedical Informatics,
Research & Biomarker Development
(DCDGNB)
Office of Pain, Anesthesia, and
Addiction Medicine (DCDGO)
Division of Anesthesia and Pain
Medicine (DCDGOA)
Division of Substance Use Disorder
Medicine (DCDGOB)
Division of Pharmacology/Toxicology
for Pain, Anesthesia, and Addiction
Medicine (DCDGOC)
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete Staff Manual Guide can find it
on FDA’s website at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2024–30334 Filed 12–23–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5353]
Privacy Act of 1974; System of
Records
Food and Drug Administration,
Department of Health and Human
Services.
AGENCY:
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ACTION:
Notice of a modified system of
records.
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 departmentwide system of
records, ‘‘Federal Advisory Committee
Membership Files,’’ System No. 09–90–
0059. The modifications include, among
other things, adding records about any
prospective guest speakers at Federal
advisory committee meetings who
disclose financial interests and
professional relationships related to the
matter they will be speaking on, and
changing the name of the system of
records to ‘‘Federal Advisory
Committee/Subgroup Member,
Subscriber/Registrant, and Guest
Speaker Records.’’
DATES: In accordance with 5 U.S.C.
552a(e)(4) and (11), the modified system
of records is effective December 26,
2024. The new and revised routine uses
will be effective January 27, 2025.
Submit any comments by January 27,
2025.
ADDRESSES: The public should submit
written comments, by mail or email, to
Beth Kramer, HHS Privacy Act Officer,
at 200 Independence Ave. SW, Suite
729H, Washington, DC 20201, or
Beth.Kramer@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
General questions about the modified
system of records should be submitted
by mail, email, or telephone to Beth
Kramer, HHS Privacy Act Officer, at 200
Independence Ave. SW, Suite 729H,
Washington, DC 20201, or
Beth.Kramer@hhs.gov or 202–690–6941.
SUPPLEMENTARY INFORMATION: This
departmentwide system of records
currently covers records retrieved by
personal identifier about: (1) members
and prospective members of HHS
advisory committees established under
the Federal Advisory Committee Act
(FACA) and (2) members of the public
who have requested to be included in
mailing lists in order to receive
publications or notices of information
issued or posted by a particular HHS
Federal advisory committee. The system
of records notice (SORN) is being
revised to add three additional
categories of individuals and records,
i.e.: (1) records about any members of
working groups or subcommittees (i.e.,
subgroups) of an HHS Federal advisory
committee who are not appointed as
members of the committee, which are
similar to the committee member
records currently covered in the SORN,
(2) records about individuals who
register to attend HHS Federal advisory
SUMMARY:
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committee meetings, which are similar
to the subscriber records currently
covered in the SORN, and (3) records
about prospective guest speakers at HHS
Federal advisory committee meetings,
which are described in section I., below;
and to make other modifications. All
modifications are summarized in
section II., below.
I. Background on Guest Speaker
Records
A ‘‘guest speaker’’ is an individual
whose professional background or other
qualifications are checked and/or who is
screened for possible conflicts of
interest (financial interests and
professional relationships) related to a
matter the guest speaker wishes to speak
on at an HHS Federal advisory
committee meeting, so that the agency
can decide whether to invite the
individual to speak and can publicly
acknowledge the speaker’s relevant
qualifications and interests at the start
of the meeting, to enable the committee
members to objectively evaluate the
speaker’s presentation. The term ‘‘guest
speaker’’ as used in SORN 09–90–0059
does not include agency employees
speaking at an HHS Federal advisory
committee meeting in an official,
governmental capacity and individual
participants in the public hearing
portion of an advisory committee
meeting. A guest speaker is either a nonFederal government employee (nonFGE) or a special government employee
(SGEs) acting in a non-official, nongovernmental capacity.
Only certain HHS components, such
as the Food and Drug Administration
(FDA), screen guest speakers for
potential conflicts of interest (all FDA
advisory committees must conduct
conflict screening of potential guest
speakers). Such screening promotes
transparency and openness in the
advisory committee process and
supports compliance with the
requirement in 5 U.S.C. 1004(b)(3) and
41 CFR 102–3.105(g) to prevent
committees’ advice and
recommendations from being influenced
by special interests. For FDA, such
screening also supports compliance
with the requirement in FDA
regulations at 21 CFR 14.60(b)(2) to
document in meeting minutes the
‘‘names and affiliations or interests of
public participants.’’
Guest speakers who are screened for
conflicts are not required to complete a
Federal confidential financial disclosure
form. The invitation extended to them
to participate as a guest speaker in an
HHS Federal advisory committee
meeting may be conditioned on their
voluntary disclosure of potential
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conflicts of interest and their consent to
public acknowledgement of their
relevant interests. The financial
interests and professional relationships
they report are reviewed by designated
agency staff and may be made available
to other agency staff if necessary to
conduct a complete review. If the guest
speaker is cleared to give a presentation
at an HHS Federal advisory committee
meeting, general information about the
types, nature, and magnitude of the
guest speaker’s interests and/or
professional relationships related to the
meeting topic will be disclosed to the
committee members and the public as
part of the conflict-of-interest statement
at the beginning of the meeting.
Note that financial and other conflict
disclosure and waiver records about
FGEs and SGEs are covered in other
SORNs, so are not covered in SORN 09–
90–0059 (see instead OGE/GOVT–1
Executive Branch Personnel Public
Financial Disclosure Reports and Other
Name-Retrieved Ethics Program
Records; OGE/GOVT–2 Executive
Branch Confidential Financial
Disclosure Reports; and 09–90–0008
Conflict of Interest Records).
II. Modifications to SORN 09–90–0059
HHS is making the following
modifications to SORN 09–90–0059:
• The system of records name has
been changed to ‘‘Federal Advisory
Committee/Subgroup Member,
Subscriber/Registrant, and Guest
Speaker Records.’’
• The System Location and System
Manager sections have been updated to
reflect current addresses and contact
information for the components and
officials responsible for the system of
records, and to mention that the General
Services Administration (GSA)
maintains facadatabase.gov as a thirdparty service provider.
• In the Authorities section, the
citation to the FACA statute has been
updated to cite ‘‘5 U.S.C. 1001 et seq.’’
instead of ‘‘5 U.S.C. App. I et seq.’’ and
these additional authorities have been
included: 5 U.S.C. 1004(b)(3) (FDAspecific authority) and 42 U.S.C.
282(b)(16) (NIH-specific authority).
• The Purpose(s) section now states
purposes for which records about the
three new categories of individuals
(working group/subcommittee members,
meeting registrants, and guest speakers)
and one existing category (subscribers)
are used; and also describes additional
purposes for which records about the
other existing category (committee
members) are used, i.e., to ensure that
members are qualified and committees
are balanced and diverse, and to
communicate with the members.
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• The Categories of Individuals and
Categories of Records sections have
been revised to add subcommittee/
working group members, meeting
registrants, and guest speakers and
records about them, and to update the
description of subscribers and records
about them to mention that a subscriber
may be included on a mailing ‘‘or
emailing’’ list.
• The Routine Use(s) section has been
revised to mention at the start that the
routine uses are in addition to other
disclosures authorized directly in the
Privacy Act at 5 U.S.C. 552a(b); and to
add nine new routine uses, revise four
existing routine uses, and delete one
routine use, as explained below:
Æ Existing routine use 1, which
formerly authorized disclosures in the
Annual Report to the President and in
administrative reports to the Office of
Management and Budget (OMB) and
GSA, has been revised to limit the
routine use to disclosures made to GSA
when HHS enters or uploads
information about committee members
or guest speakers in facadatabase.gov.
Æ Routine use 2 is new; it authorizes
HHS to publicly disclose on its websites
and in facadatabase.gov the names of
and limited information about the
qualifications and financial disclosures
of members of FACA committees,
subcommittees, and working groups,
and guest speakers, limited to
information that would be required to
be disclosed to a requester under the
Freedom of Information Act (FOIA).
Æ Existing routine use 3 (formerly
listed second), which authorizes records
indicating a violation or potential
violation of law to be referred to the
responsible investigatory or
enforcement agency, has been revised to
add ‘‘state, local, Tribal, and other’’ to
the description of recipient agencies; to
permit ‘‘relevant’’ records to be
disclosed ‘‘when HHS becomes aware of
evidence of’’ a potential violation of
law; and to explain that, in most cases,
the disclosures would be made after first
referring the information to another
HHS component, such as the HHS
Office of the General Counsel or the
HHS Office of the Inspector General, to
determine if the information is
appropriate to refer to an outside
agency, and that if that component
made the referral, the equivalent routine
use published in that component’s
SORN would apply to the disclosure.
Æ The routine use that was formerly
listed third has been deleted. It
authorized disclosures to the
Department of Justice (DOJ) to obtain its
advice regarding whether particular
records are required to be disclosed
under FOIA. The routine use is
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unnecessary, because such advice is
provided by the HHS Office of the
General Counsel, and any disclosures
that need to be made to DOJ in
connection with FOIA litigation are
authorized in a separate, litigationrelated routine use.
Æ Existing routine use 4, which
authorizes disclosures to DOJ in
litigation, has been revised to include
‘‘other adjudicative proceedings;’’ to
add ‘‘a court or other adjudicative body’’
as disclosure recipients; to require that
the information disclosed be ‘‘relevant
and necessary’’ to the proceedings; and
to remove the requirement that
disclosures be compatible with the
purpose for which the records were
collected, because such wording repeats
part of the definition of a routine use.
Æ Existing routine use 5, which
authorizes disclosures about an
individual in responding to an inquiry
from a congressional office made at the
individual’s request, has been revised to
require that the congressional inquiry
and the individual’s request to the
congressional office be ‘‘written.’’
Æ Existing routine use 6, which was
added in 1994, is included without
change.
Æ Routine uses 7 through 14 are new.
They authorize disclosures to Federal
agencies and contractors engaged by
HHS to assist with matters related to
this system of records (routine use 7);
disclosures to the committee
chairperson or vice chairperson for
committee work purposes (routine use
8); disclosures to the Executive Office of
the President, OMB, or other agencies
for coordination on advisory committee
member selection (routine use 9);
disclosures to any source from which
information is needed by HHS to
support an HHS decision involving the
individual (routine use 10); disclosures
to aid another government agency’s
decision on a hiring, licensing,
contracting, security clearance, or other
matter involving the individual (routine
use 11); disclosures to the National
Archives and Records Administration
(NARA) or other relevant Federal
agencies in records management
inspections (routine use 12); disclosures
to Federal agencies and entities for
program evaluation or assessment
purposes (routine use 13); and
disclosures to the Department of
Homeland Security (DHS) for
cybersecurity monitoring purposes
(routine use 14).
Æ Existing routine uses 15 and 16,
which were added in 2018, are included
without change.
• The Storage section has been
updated to remove references to ‘‘index
cards’’ and ‘‘magnetic tape.’’
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• The Retrieval section has been
revised to remove references to ‘‘an
alphabetical index,’’ ‘‘a cross index,’’
and ‘‘individually identifiable computer
identification codes,’’ and to simply
state that records are retrieved by the
subject individual’s name, with the
exception of records about subscribers,
which are retrieved by the subscriber’s
name or email address.
• The Retention section, which
previously stated that retention varies
from 1 year to permanent depending on
the type of record, now cites the
applicable NARA-approved disposition
schedules and itemizes the record types
and disposition periods applicable to
each.
• The Safeguards section has been
updated to remove a reference to
‘‘locked magnetic tape libraries’’ and to
list current safeguards used to protect
records stored in electronic media,
instead of ‘‘lockword-password
computer access systems.’’
• The sections specifying procedures
for making access, amendment, and
notification requests have been revised
to specify the required contents for each
type of request, including identity
verification information that must be
provided (the existing SORN specified
the required contents of amendment
requests only, and merely stated that
identity was required to be verified in
accordance with Department’s Privacy
Act regulations).
Because some of these changes are
significant, a report on the modified
system of records has been sent to OMB
and the Congressional committees that
oversee privacy, in accordance with 5
U.S.C. 552a(r).
SYSTEM NAME AND NUMBER:
Federal Advisory Committee/
Subgroup Member, Subscriber/
Registrant, and Guest Speaker Records,
09–90–0059.
SECURITY CLASSIFICATION:
Unclassified.
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SYSTEM LOCATION:
The addresses of the agency
components responsible for the system
of records are listed below. At HHS,
Federal advisory committee records are
not centralized at the Department level
or Operating Division level; instead,
each committee’s Designated Federal
Officer (DFO) maintains the records
pertaining to that committee. (Note that
the manner of maintenance may vary.
Records pertaining to a particular
committee will constitute Privacy Act
records only if the DFO maintains them
in a paper-based or electronic
recordkeeping system from which the
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records are retrieved by the subject
individuals’ names or other personal
identifiers.) For purposes of
simplification, one address is provided
for each HHS Operating Division
(OpDiv).
OS: Advisory Committee Oversight
Staff, Immediate Office of the Secretary
of HHS, 200 Independence Ave. SW,
Washington, DC 20201, 1–877–696–
6775.
ACF: Advisory Committee Oversight
Staff, Administration for Children &
Families, 330 C St. SW, Washington, DC
20201, 202–401–9215.
ACL: Advisory Committee Oversight
Staff, Administration for Community
Living, 330 C St. SW, Washington, DC
20201, 202–401–4634.
AHRQ: Advisory Committee
Oversight Staff, Immediate Office of the
Director, Administration for Healthcare
Research and Quality, 540 Gaither Rd.,
Rockville, MD 20850, director@
ahrq.hhs.gov.
ASPR: Advisory Committee Oversight
Staff, Administration for Strategic
Preparedness and Response, 400 7th St.
SW, Washington, DC 20201; use the
email address for the particular
committee, shown on ASPR’s ‘‘Boards
and Committees’’ web page.
CDC: Office of the FAC Act Program,
Centers for Disease Control and
Prevention, 1600 Clifton Rd. NE—M/S:
TW–2, Atlanta, GA 30333, 770–488–
4707, FACMT@cdc.gov.
CMS: Advisory Committee Oversight
Staff, Centers for Medicare & Medicaid
Services, 7500 Security Blvd.,
Baltimore, MD 21244, 410–786–3000.
FDA: Advisory Committee Oversight
and Management Staff (ACOMS), Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, ACOMSSubmissions@
fda.hhs.gov.
HRSA: FACA Management Officer,
Executive Secretariat, Health Resources
and Services Administration, 5600
Fishers Lane—13W18, Rockville, MD
20857, 301–443–1785.
IHS: Deputy Director for
Intergovernmental Affairs, Indian
Health Service, 5600 Fishers Lane,
Rockville, MD 20857, Stacey.Ecoffey@
ihs.gov.
NIH: Office of Federal Advisory
Committee Policy, National Institutes of
Health, 9000 Rockville Pike, Bethesda,
MD 20892, ofacpinfo@od.nih.gov.
SAMHSA: Advisory Committee
Oversight Staff, Substance Abuse and
Mental Health Services Administration,
5600 Fishers Lane, Rockville, MD
20857, NationalAdvisoryCouncils@
samhsa@hhs.gov.
GSA, as a third-party service provider,
maintains the web-based
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facadatabase.gov system that HHS uses
to make certain records available to
Congress and the public as required to
inform them of the existence and
activities of HHS Federal advisory
committees. GSA’s address is: U.S.
General Services Administration,
Committee Management Secretariat,
1800 F St. NW, Washington, DC 20405.
SYSTEM MANAGER(S):
Each committee’s Committee
Management Officer (CMO) is
responsible for the records in this
system of records that pertain to that
committee, including records about any
subcommittees, working groups, or
other subgroups formed under the
committee. Contact information for the
current CMO for each active and
recently (i.e., within 1 fiscal year)
terminated committee can be found on
https://www.facadatabase.gov. Contact
information for records pertaining to a
committee which has been terminated
and is no longer in that database may be
obtained by contacting the relevant
OpDiv at the OpDiv’s mailing address,
email address, and/or telephone number
shown in the System Location section,
above.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Federal Advisory Committee Act
(FACA), 5 U.S.C. 1001 et seq. See also
5 U.S.C. 1004(b)(3) (FDA-specific
authority) and 42 U.S.C. 282(b)(16)
(NIH-specific authority).
PURPOSE(S) OF THE SYSTEM:
Records in this system of records are
used in the administration and
management of Federal advisory
committees (including any subgroups of
same) in the Department, including for
these specific purposes:
• Records about members or
prospective members of a Federal
advisory committee or subgroup are
used (1) in the preparation of reports;
quarterly alphabetical listings of past,
present, and recommended members;
lists of vacancies, acceptances, and
separations; and documentation of
nominations; (2) to identify the most
qualified applicants and ensure that the
makeup of the committee,
subcommittee, or working group is
sufficiently balanced and diverse (see 41
CFR part 102–3.30(c)); (3) to ensure
compliance with ethics and conflict-ofinterest requirements; and (4) to
communicate with the members about
committee or subgroup activities.
• Records about guest speakers are
used to determine whether the speakers
will be invited to give a presentation on
the matter in question and to inform the
committee members of the speakers’
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qualifications and/or financial interests
and professional relationships
pertaining to the matter before the
committee, so that the members can
objectively evaluate each speaker’s
presentation.
• Records about subscribers
(members of the public who subscribe to
receive publications or other
information issued or posted by a
particular Federal advisory committee)
are used for the purpose of maintaining
the subscriber list (i.e., to add, update,
or remove a subscriber’s contact
information when requested by that
individual) and may also be used to
indicate if a particular subscriber needs
to receive information in a particular
format, as a reasonable accommodation,
in order to provide information to that
subscriber in that format.
• Records about registrants (members
of the public who register as attendees
for in-person and web-based Federal
advisory committee meetings) are used
for the purpose of maintaining the
meeting registration lists and may also
be used to indicate if a particular
registrant needs a sign language
interpreter, wheelchair access, or other
accommodation to participate in a
meeting.
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CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The records are about these categories
of individuals:
• Committee members. Individuals
who have been or presently are
members of, or are being considered for,
membership on a Federal advisory
committee within the jurisdiction of
HHS. Individuals may be appointed to
serve on an advisory committee as a
FGE pursuant to 42 CFR 102–3.130(a);
as a NIH peer review consultant as
authorized by 42 U.S.C. 282(b)(16); as a
SGE pursuant to 5 U.S.C. 3109; or as a
representative member when directed
by statute or regulation (see, for
example, 21 U.S.C. 360c(b) regarding
representative members of FDA device
panels, and 21 CFR 14.84 regarding
representative members of standing
technical advisory committees who
represent consumer and industry
interests).
• Subcommittee and working group
members (some may also be committee
members, covered in the preceding
category).
• Guest speakers. Individuals whose
professional background or other
qualifications are checked and/or who
are screened for possible conflicts of
interest (financial interests and
professional relationships) related to a
matter they wish to speak on before an
HHS Federal advisory committee (they
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may be non-Federal government
employees or special government
employees acting in a non-official, nongovernmental capacity).
• Subscribers. Individual members of
the public who have asked to be
included in a Federal advisory
committee mailing or emailing list to
receive publications and other
information from the committee.
• Meeting registrants. Individual
members of the public who register to
attend public Federal advisory
committee meetings.
CATEGORIES OF RECORDS IN THE SYSTEM:
The categories of records are:
• Records about members and
prospective members of HHS Federal
advisory committees. These records
consist of membership records,
accountability records, and management
records, containing name and other data
such as the following about each
member or prospective member: title,
gender, place and date of birth, contact
information (e.g., home address,
business address, telephone number,
email address), contact information for
any assistant or organization contact
assisting the member or prospective
member, organizational affiliation,
degrees held, general educational
background, ethnic background, resume,
curriculum vitae, dates of term on
advisory committee, status on advisory
committee, reason for leaving advisory
committee, indication of previous or
current membership on other advisory
committees, special qualifications for
the advisory committee membership,
source or references who recommended
the individual for membership on
advisory committee, copies of any forms
filed with the Office of Government
Ethics (OGE) such as OGE Form 450,
and miscellaneous correspondence.
Additionally, memoranda justifying the
individual’s selection are included in
the file if the individual doesn’t meet
certain statutory or other requirements
for advisory committee membership (for
example, where the individual has
served repetitively on advisory
committees and a policy requires a
break in service).
• Records about members or
prospective members of HHS Federal
advisory committee working groups or
subcommittees (subgroups). These
records are similar to, but not coextensive with, records about members
and prospective members of
committees, described above (for
example, the OGE Form 450 isn’t
completed by subgroup members and
prospective members unless they are
also committee members or prospective
members).
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• Records about guest speakers.
These consist of the completed
disclosure form, containing the
individual’s identifying information and
information about the individual’s
financial interests and professional
relationships (such as: name, Federal
employment status, securities held,
contracts, grants, consulting, and
professional relationships such as those
with an employer, firm, organization or
a person in the individual’s professional
network); and internal and external
correspondence and associated
information compiled by the agency in
reviewing the disclosures.
• Records about subscribers. Such
records typically are limited to the
individual’s name and mailing address
or email address and, if applicable,
preferred format.
• Records about meeting registrants.
Such records include the individual’s
contact information and, if applicable,
reasonable accommodation requests.
Demographic information may also be
included, if the particular registration
form requests it.
RECORD SOURCE CATEGORIES:
All information about a subscriber or
meeting registrant is obtained directly
from that individual. The vast majority
of information about a committee
member or prospective member, or a
subcommittee or working group member
or prospective member, is obtained
directly from that individual, or from
the individual’s administrative assistant
or organization contact; other
information in the form of references
and recommendations is obtained from
other private individuals, program
personnel, biographical reference books,
private organizations, former employers,
regional offices of HHS, Members of
Congress, and other government
sources. Information about a prospective
guest speaker is provided directly by the
individual or is derived or obtained
from materials supplied by the
individual, from observation and
analysis made by agency staff, from
correspondence between the agency and
the individual, and from any other
relevant source necessary to conduct a
complete a review of the individual’s
disclosed qualifications and/or interests.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
PURPOSES OF SUCH USES:
In addition to other disclosures which
are authorized directly in the Privacy
Act statute at 5 U.S.C. 552a(b),
information about a subject individual
may be disclosed from this system of
records to non-HHS officers and
employees, without the subject
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individual’s consent, as provided in
these routine uses which are published
pursuant to 5 U.S.C. 552a(b)(3):
1. Records about committee members
and guest speakers may be disclosed to
GSA when HHS enters and uploads
committee information and records in
GSA’s facadatabase.gov system, for the
purpose of keeping Congress and the
public informed of the existence,
membership, and activities of advisory
committees as authorized by the FACA
at 5 U.S.C. 1002(b)(5). Committee
member names are also disclosed in
administrative reports to the President
and OMB.
2. HHS may publicly disclose the
names of and limited information about
qualifications (e.g., professional
backgrounds) and financial disclosures
of members of HHS Federal advisory
committees, subcommittees, and
working groups, and about guest
speakers, on its websites and in
facadatabase.gov. Information made
public will be limited to information
that HHS would be required to release
to a requester under FOIA; meaning,
information that would not result in a
clearly unwarranted invasion of privacy.
3. Relevant records may be disclosed
to appropriate Federal, State, local, or
Tribal agencies; international agencies;
or foreign governments responsible for
investigating, prosecuting, enforcing, or
implementing statutes, rules,
regulations, or orders, when HHS
becomes aware of evidence of a
potential violation of civil or criminal
law. In most cases, these disclosures
will be made after first referring the
information to another HHS component,
such as the HHS Office of the General
Counsel or the HHS Office of the
Inspector General, to determine if the
information is appropriate to refer to an
outside law enforcement or other
appropriate agency; if that component
makes the disclosure to an outside
agency, the equivalent routine use
published in that component’s SORN
would apply instead of this routine use.
4. Records may be disclosed to DOJ or
to a court or other adjudicative body in
litigation or other adjudicative
proceedings when HHS or any of its
components, or any employee of HHS in
his or her official capacity, or any
employee of HHS in his or her
individual capacity where the DOJ or
HHS has agreed to represent the
employee, or the United States, 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.
5. Disclosure may be made to a
congressional office from the record of
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an individual in response to a written
inquiry from the congressional office
made at the written request of that
individual.
6. Records may be disclosed to
student volunteers, individuals working
under a personal services contract, and
other individuals performing functions
for the Department but technically not
having the status of agency employees,
if they need to access the records in
order to perform their assigned agency
functions.
7. Disclosures may be made to Federal
agencies and HHS contractors that have
been engaged by HHS to assist in
accomplishment of an HHS function
relating to the purposes of this system
of records (including ancillary
functions, such as compiling reports
and evaluating program effectiveness
and contractor performance) and that
have a need to have access to the
records in order to assist HHS in
performing the activity. Any contractor
will be required to comply with the
requirements of the Privacy Act.
8. Records may be disclosed to the
Chairperson or Vice Chairperson of the
relevant advisory committee to use for
purposes such as determining
membership on subcommittees,
assigning tasks to members, and
distributing information to members for
meeting or other committee work
purposes.
9. Records may be disclosed to the
Executive Office of the President, the
Office of Management and Budget, or
other agencies for coordination on
advisory committee member selection.
10. Records about a member or
prospective member or guest speaker
may be disclosed to any source from
which additional information is
requested by HHS (to the extent
necessary to identify the individual,
inform the source of the purpose of the
request, and identify the type of
information requested) when necessary
to obtain information relevant to an
HHS decision involving the individual.
11. Records may be disclosed to a
Federal, foreign, State, local, Tribal, or
other public authority of the fact that
this system of records contains
information relevant to that entity’s
decision regarding hiring or retention of
an employee, retention of a security
clearance, letting of a contract, or
issuance or retention of a license, grant
or other benefit, so that it may then
make a request supported by the written
consent of the individual for further
information if it so chooses. HHS will
not make an initial disclosure unless the
information has been determined to be
sufficiently reliable to support a referral
to another office within the agency or to
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
another Federal agency for criminal,
civil, administrative, personnel, or
regulatory action.
12. HHS may disclose records from
this system of records to NARA, GSA,
or other relevant Federal agencies in
connection with records management
inspections conducted under the
authority of 44 U.S.C. 2904 and 2906.
13. Records may be disclosed to
Federal agencies and entities (e.g., the
Office of Government Ethics, the
Government Accountability Office, or
the General Services Administration) for
program evaluation and assessment
purposes, if disclosure of identifiable
records is deemed appropriate by HHS
counsel.
14. Records may be disclosed to 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.
15. Disclosures may be made to
appropriate agencies, entities, and
persons when (1) HHS suspects or has
confirmed that there has been a breach
of the system of records; (2) HHS has
determined that as a result of the
suspected or confirmed breach there is
a risk of harm to individuals, HHS
(including its information systems,
programs, and operations), the Federal
Government, or national security; and
(3) the disclosure made to such
agencies, entities, and persons is
reasonably necessary to assist in
connection with HHS efforts to respond
to the suspected or confirmed breach or
to prevent, minimize, or remedy such
harm.
16. Disclosure may be made to
another Federal agency or Federal
entity, when HHS determines that
information from this system of records
is reasonably necessary to assist the
recipient agency or entity in (1)
responding to a suspected or confirmed
breach or (2) preventing, minimizing, or
remedying the risk of harm to
individuals, the recipient agency or
entity (including its information
systems, programs, and operations), the
Federal Government, or national
security, resulting from a suspected or
confirmed breach.
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
Records are stored in hard-copy files
and on electronic media.
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
Records are retrieved by the subject
individual’s name, with the exception of
E:\FR\FM\26DEN1.SGM
26DEN1
Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices
records about subscribers, which are
retrieved by the subscriber’s name or
email address.
POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
ddrumheller on DSK120RN23PROD with NOTICES1
Records about individuals who serve
as members of Federal advisory
committees and subgroups are retained
and disposed of in accordance with
NARA General Records Schedule (GRS)
6.2, Items 010, 040, and 050:
• Item 010 Substantive Committee
Records requires substantive records
related to committee and subgroup
membership to be accessioned to the
National Archives for permanent
retention when the records are 15 years
old or older or upon termination of the
committee, whichever is sooner.
• Item 040 Committee Accountability
Records (note that this item excludes
forms filed under the Ethics in
Government Act, and such forms are not
covered by this SORN) authorizes
accountability records (such as records
about members’ financial disclosures
and conflicts of interest, and records
documenting travel and other payments
to or for committee members) to be
destroyed when 6 years old unless
longer retention is required for business
use.
• Item 050 Non-substantive
Committee Records authorizes records
of an administrative nature, such as
those documenting members’ and
prospective members’ credentials, to be
destroyed when superseded, obsolete, or
no longer needed, or upon termination
of the committee, whichever is sooner.
Records about prospective members
of Federal advisory committees are
retained and disposed of in accordance
with GRS 6.2, Item 050 (see above).
Records about guest speakers are
disposed of in accordance with GRS 6.2,
Item 040 (see above).
Records about meeting registrants and
subscribers are retained and disposed of
in accordance with GRS 6.5, Item 020,
which authorizes sign-up forms and
distribution lists for distributing
information such as publications and
data produced by the agency to be
deleted when superseded or obsolete or
when the customer requests the agency
to remove the records.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
Records are protected from
unauthorized access through
appropriate administrative, physical,
and technical safeguards. Safeguards
conform to the HHS Information
Security and Privacy Program, https://
www.hhs.gov/ocio/securityprivacy/. The
safeguards include protecting the
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19:37 Dec 23, 2024
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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, the
principle of least privilege, and either
two-factor authentication or user ID and
password; using a secured operating
system protected by encryption,
firewalls, and intrusion detection
systems; encrypting data transmissions
and records stored on removable media;
using secure destruction methods
prescribed in National Institute of
Standards and Technology Special
Publication 800–88 to dispose of eligible
records; and training personnel in
Privacy Act and information security
requirements.
An individual seeking access to
records about him or her in this system
of records must submit a written access
request to the relevant System Manager,
at the address indicated in the ‘‘System
Manager(s)’’ section, above, in
accordance with the Department’s
Privacy Act implementation regulations
in 45 CFR. The request must contain the
individual’s full name and address, and,
for identity verification purposes,
signature, and date and place of birth.
In addition, to verify the individual’s
identity, the individual must provide
either a notarized request or a written
certification that the individual is who
he or she claims to be and understands
that the knowing and willful request for
acquisition of a record pertaining to an
individual under false pretenses is a
criminal offense under the Privacy Act,
subject to a fine of up to $5,000.
CONTESTING RECORD PROCEDURES:
An individual seeking to amend a
record about him or her in this system
of records must submit a written
amendment request to the relevant
System Manager, at the address
indicated in the ‘‘System Manager(s)’’
section, above, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request must contain the same
information required for an access
request, and must reasonably identify
the record, specify the information
contested, state the corrective action
sought, provide the reasons for the
amendment, and include any
supporting justification or
documentation. The individual must
verify his or her identity in the same
manner required for an access request.
The right to contest records is limited to
information that is factually inaccurate,
Frm 00095
Fmt 4703
Sfmt 4703
incomplete, irrelevant, or untimely
(obsolete).
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system of records contains records
about him or her must submit a written
notification request to the relevant
System Manager at the address
indicated in the ‘‘System Manager(s)’’
section, above, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request must contain the same
information required for an access
request, and the individual must verify
his or her identity in the same manner
required for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
RECORD ACCESS PROCEDURES:
PO 00000
105059
47 FR 45514 (October 13, 1982); 59 FR
55845 (November 9, 1994); 83 FR 6591
(February 14, 2018).
Dated: December 13, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–30782 Filed 12–23–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4776]
Export Lists for Human Food: Request
for Information; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for information;
extension of comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
request for information, published in
the Federal Register of November 8,
2024. In that notice, FDA invited
comment relating to the listing
requirements of other countries and
FDA’s approach to facilitating U.S.
industry compliance with these
requirements through the issuance of
export certification for human food
products provided in the form of lists
(export lists). We are extending the
comment period to allow interested
persons additional time to submit
comments on FDA’s approach.
DATES: FDA is extending the comment
period announced in the notice for
request for information published
November 8, 2024 (89 FR 88785).
SUMMARY:
E:\FR\FM\26DEN1.SGM
26DEN1
Agencies
[Federal Register Volume 89, Number 247 (Thursday, December 26, 2024)]
[Notices]
[Pages 105054-105059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5353]
Privacy Act of 1974; System of Records
AGENCY: Food and Drug Administration, 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 departmentwide system of records, ``Federal
Advisory Committee Membership Files,'' System No. 09-90-0059. The
modifications include, among other things, adding records about any
prospective guest speakers at Federal advisory committee meetings who
disclose financial interests and professional relationships related to
the matter they will be speaking on, and changing the name of the
system of records to ``Federal Advisory Committee/Subgroup Member,
Subscriber/Registrant, and Guest Speaker Records.''
DATES: In accordance with 5 U.S.C. 552a(e)(4) and (11), the modified
system of records is effective December 26, 2024. The new and revised
routine uses will be effective January 27, 2025. Submit any comments by
January 27, 2025.
ADDRESSES: The public should submit written comments, by mail or email,
to Beth Kramer, HHS Privacy Act Officer, at 200 Independence Ave. SW,
Suite 729H, Washington, DC 20201, or [email protected].
FOR FURTHER INFORMATION CONTACT: General questions about the modified
system of records should be submitted by mail, email, or telephone to
Beth Kramer, HHS Privacy Act Officer, at 200 Independence Ave. SW,
Suite 729H, Washington, DC 20201, or [email protected] or 202-690-
6941.
SUPPLEMENTARY INFORMATION: This departmentwide system of records
currently covers records retrieved by personal identifier about: (1)
members and prospective members of HHS advisory committees established
under the Federal Advisory Committee Act (FACA) and (2) members of the
public who have requested to be included in mailing lists in order to
receive publications or notices of information issued or posted by a
particular HHS Federal advisory committee. The system of records notice
(SORN) is being revised to add three additional categories of
individuals and records, i.e.: (1) records about any members of working
groups or subcommittees (i.e., subgroups) of an HHS Federal advisory
committee who are not appointed as members of the committee, which are
similar to the committee member records currently covered in the SORN,
(2) records about individuals who register to attend HHS Federal
advisory committee meetings, which are similar to the subscriber
records currently covered in the SORN, and (3) records about
prospective guest speakers at HHS Federal advisory committee meetings,
which are described in section I., below; and to make other
modifications. All modifications are summarized in section II., below.
I. Background on Guest Speaker Records
A ``guest speaker'' is an individual whose professional background
or other qualifications are checked and/or who is screened for possible
conflicts of interest (financial interests and professional
relationships) related to a matter the guest speaker wishes to speak on
at an HHS Federal advisory committee meeting, so that the agency can
decide whether to invite the individual to speak and can publicly
acknowledge the speaker's relevant qualifications and interests at the
start of the meeting, to enable the committee members to objectively
evaluate the speaker's presentation. The term ``guest speaker'' as used
in SORN 09-90-0059 does not include agency employees speaking at an HHS
Federal advisory committee meeting in an official, governmental
capacity and individual participants in the public hearing portion of
an advisory committee meeting. A guest speaker is either a non-Federal
government employee (non-FGE) or a special government employee (SGEs)
acting in a non-official, non-governmental capacity.
Only certain HHS components, such as the Food and Drug
Administration (FDA), screen guest speakers for potential conflicts of
interest (all FDA advisory committees must conduct conflict screening
of potential guest speakers). Such screening promotes transparency and
openness in the advisory committee process and supports compliance with
the requirement in 5 U.S.C. 1004(b)(3) and 41 CFR 102-3.105(g) to
prevent committees' advice and recommendations from being influenced by
special interests. For FDA, such screening also supports compliance
with the requirement in FDA regulations at 21 CFR 14.60(b)(2) to
document in meeting minutes the ``names and affiliations or interests
of public participants.''
Guest speakers who are screened for conflicts are not required to
complete a Federal confidential financial disclosure form. The
invitation extended to them to participate as a guest speaker in an HHS
Federal advisory committee meeting may be conditioned on their
voluntary disclosure of potential
[[Page 105055]]
conflicts of interest and their consent to public acknowledgement of
their relevant interests. The financial interests and professional
relationships they report are reviewed by designated agency staff and
may be made available to other agency staff if necessary to conduct a
complete review. If the guest speaker is cleared to give a presentation
at an HHS Federal advisory committee meeting, general information about
the types, nature, and magnitude of the guest speaker's interests and/
or professional relationships related to the meeting topic will be
disclosed to the committee members and the public as part of the
conflict-of-interest statement at the beginning of the meeting.
Note that financial and other conflict disclosure and waiver
records about FGEs and SGEs are covered in other SORNs, so are not
covered in SORN 09-90-0059 (see instead OGE/GOVT-1 Executive Branch
Personnel Public Financial Disclosure Reports and Other Name-Retrieved
Ethics Program Records; OGE/GOVT-2 Executive Branch Confidential
Financial Disclosure Reports; and 09-90-0008 Conflict of Interest
Records).
II. Modifications to SORN 09-90-0059
HHS is making the following modifications to SORN 09-90-0059:
The system of records name has been changed to ``Federal
Advisory Committee/Subgroup Member, Subscriber/Registrant, and Guest
Speaker Records.''
The System Location and System Manager sections have been
updated to reflect current addresses and contact information for the
components and officials responsible for the system of records, and to
mention that the General Services Administration (GSA) maintains
facadatabase.gov as a third-party service provider.
In the Authorities section, the citation to the FACA
statute has been updated to cite ``5 U.S.C. 1001 et seq.'' instead of
``5 U.S.C. App. I et seq.'' and these additional authorities have been
included: 5 U.S.C. 1004(b)(3) (FDA-specific authority) and 42 U.S.C.
282(b)(16) (NIH-specific authority).
The Purpose(s) section now states purposes for which
records about the three new categories of individuals (working group/
subcommittee members, meeting registrants, and guest speakers) and one
existing category (subscribers) are used; and also describes additional
purposes for which records about the other existing category (committee
members) are used, i.e., to ensure that members are qualified and
committees are balanced and diverse, and to communicate with the
members.
The Categories of Individuals and Categories of Records
sections have been revised to add subcommittee/working group members,
meeting registrants, and guest speakers and records about them, and to
update the description of subscribers and records about them to mention
that a subscriber may be included on a mailing ``or emailing'' list.
The Routine Use(s) section has been revised to mention at
the start that the routine uses are in addition to other disclosures
authorized directly in the Privacy Act at 5 U.S.C. 552a(b); and to add
nine new routine uses, revise four existing routine uses, and delete
one routine use, as explained below:
[cir] Existing routine use 1, which formerly authorized disclosures
in the Annual Report to the President and in administrative reports to
the Office of Management and Budget (OMB) and GSA, has been revised to
limit the routine use to disclosures made to GSA when HHS enters or
uploads information about committee members or guest speakers in
facadatabase.gov.
[cir] Routine use 2 is new; it authorizes HHS to publicly disclose
on its websites and in facadatabase.gov the names of and limited
information about the qualifications and financial disclosures of
members of FACA committees, subcommittees, and working groups, and
guest speakers, limited to information that would be required to be
disclosed to a requester under the Freedom of Information Act (FOIA).
[cir] Existing routine use 3 (formerly listed second), which
authorizes records indicating a violation or potential violation of law
to be referred to the responsible investigatory or enforcement agency,
has been revised to add ``state, local, Tribal, and other'' to the
description of recipient agencies; to permit ``relevant'' records to be
disclosed ``when HHS becomes aware of evidence of'' a potential
violation of law; and to explain that, in most cases, the disclosures
would be made after first referring the information to another HHS
component, such as the HHS Office of the General Counsel or the HHS
Office of the Inspector General, to determine if the information is
appropriate to refer to an outside agency, and that if that component
made the referral, the equivalent routine use published in that
component's SORN would apply to the disclosure.
[cir] The routine use that was formerly listed third has been
deleted. It authorized disclosures to the Department of Justice (DOJ)
to obtain its advice regarding whether particular records are required
to be disclosed under FOIA. The routine use is unnecessary, because
such advice is provided by the HHS Office of the General Counsel, and
any disclosures that need to be made to DOJ in connection with FOIA
litigation are authorized in a separate, litigation-related routine
use.
[cir] Existing routine use 4, which authorizes disclosures to DOJ
in litigation, has been revised to include ``other adjudicative
proceedings;'' to add ``a court or other adjudicative body'' as
disclosure recipients; to require that the information disclosed be
``relevant and necessary'' to the proceedings; and to remove the
requirement that disclosures be compatible with the purpose for which
the records were collected, because such wording repeats part of the
definition of a routine use.
[cir] Existing routine use 5, which authorizes disclosures about an
individual in responding to an inquiry from a congressional office made
at the individual's request, has been revised to require that the
congressional inquiry and the individual's request to the congressional
office be ``written.''
[cir] Existing routine use 6, which was added in 1994, is included
without change.
[cir] Routine uses 7 through 14 are new. They authorize disclosures
to Federal agencies and contractors engaged by HHS to assist with
matters related to this system of records (routine use 7); disclosures
to the committee chairperson or vice chairperson for committee work
purposes (routine use 8); disclosures to the Executive Office of the
President, OMB, or other agencies for coordination on advisory
committee member selection (routine use 9); disclosures to any source
from which information is needed by HHS to support an HHS decision
involving the individual (routine use 10); disclosures to aid another
government agency's decision on a hiring, licensing, contracting,
security clearance, or other matter involving the individual (routine
use 11); disclosures to the National Archives and Records
Administration (NARA) or other relevant Federal agencies in records
management inspections (routine use 12); disclosures to Federal
agencies and entities for program evaluation or assessment purposes
(routine use 13); and disclosures to the Department of Homeland
Security (DHS) for cybersecurity monitoring purposes (routine use 14).
[cir] Existing routine uses 15 and 16, which were added in 2018,
are included without change.
The Storage section has been updated to remove references
to ``index cards'' and ``magnetic tape.''
[[Page 105056]]
The Retrieval section has been revised to remove
references to ``an alphabetical index,'' ``a cross index,'' and
``individually identifiable computer identification codes,'' and to
simply state that records are retrieved by the subject individual's
name, with the exception of records about subscribers, which are
retrieved by the subscriber's name or email address.
The Retention section, which previously stated that
retention varies from 1 year to permanent depending on the type of
record, now cites the applicable NARA-approved disposition schedules
and itemizes the record types and disposition periods applicable to
each.
The Safeguards section has been updated to remove a
reference to ``locked magnetic tape libraries'' and to list current
safeguards used to protect records stored in electronic media, instead
of ``lockword-password computer access systems.''
The sections specifying procedures for making access,
amendment, and notification requests have been revised to specify the
required contents for each type of request, including identity
verification information that must be provided (the existing SORN
specified the required contents of amendment requests only, and merely
stated that identity was required to be verified in accordance with
Department's Privacy Act regulations).
Because some of these changes are significant, a report on the
modified system of records has been sent to OMB and the Congressional
committees that oversee privacy, in accordance with 5 U.S.C. 552a(r).
SYSTEM NAME AND NUMBER:
Federal Advisory Committee/Subgroup Member, Subscriber/Registrant,
and Guest Speaker Records, 09-90-0059.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The addresses of the agency components responsible for the system
of records are listed below. At HHS, Federal advisory committee records
are not centralized at the Department level or Operating Division
level; instead, each committee's Designated Federal Officer (DFO)
maintains the records pertaining to that committee. (Note that the
manner of maintenance may vary. Records pertaining to a particular
committee will constitute Privacy Act records only if the DFO maintains
them in a paper-based or electronic recordkeeping system from which the
records are retrieved by the subject individuals' names or other
personal identifiers.) For purposes of simplification, one address is
provided for each HHS Operating Division (OpDiv).
OS: Advisory Committee Oversight Staff, Immediate Office of the
Secretary of HHS, 200 Independence Ave. SW, Washington, DC 20201, 1-
877-696-6775.
ACF: Advisory Committee Oversight Staff, Administration for
Children & Families, 330 C St. SW, Washington, DC 20201, 202-401-9215.
ACL: Advisory Committee Oversight Staff, Administration for
Community Living, 330 C St. SW, Washington, DC 20201, 202-401-4634.
AHRQ: Advisory Committee Oversight Staff, Immediate Office of the
Director, Administration for Healthcare Research and Quality, 540
Gaither Rd., Rockville, MD 20850, [email protected].
ASPR: Advisory Committee Oversight Staff, Administration for
Strategic Preparedness and Response, 400 7th St. SW, Washington, DC
20201; use the email address for the particular committee, shown on
ASPR's ``Boards and Committees'' web page.
CDC: Office of the FAC Act Program, Centers for Disease Control and
Prevention, 1600 Clifton Rd. NE--M/S: TW-2, Atlanta, GA 30333, 770-488-
4707, [email protected].
CMS: Advisory Committee Oversight Staff, Centers for Medicare &
Medicaid Services, 7500 Security Blvd., Baltimore, MD 21244, 410-786-
3000.
FDA: Advisory Committee Oversight and Management Staff (ACOMS),
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993, [email protected].
HRSA: FACA Management Officer, Executive Secretariat, Health
Resources and Services Administration, 5600 Fishers Lane--13W18,
Rockville, MD 20857, 301-443-1785.
IHS: Deputy Director for Intergovernmental Affairs, Indian Health
Service, 5600 Fishers Lane, Rockville, MD 20857,
[email protected].
NIH: Office of Federal Advisory Committee Policy, National
Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892,
[email protected].
SAMHSA: Advisory Committee Oversight Staff, Substance Abuse and
Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD
20857, NationalAdvisoryCouncils@[email protected].
GSA, as a third-party service provider, maintains the web-based
facadatabase.gov system that HHS uses to make certain records available
to Congress and the public as required to inform them of the existence
and activities of HHS Federal advisory committees. GSA's address is:
U.S. General Services Administration, Committee Management Secretariat,
1800 F St. NW, Washington, DC 20405.
SYSTEM MANAGER(S):
Each committee's Committee Management Officer (CMO) is responsible
for the records in this system of records that pertain to that
committee, including records about any subcommittees, working groups,
or other subgroups formed under the committee. Contact information for
the current CMO for each active and recently (i.e., within 1 fiscal
year) terminated committee can be found on https://www.facadatabase.gov. Contact information for records pertaining to a
committee which has been terminated and is no longer in that database
may be obtained by contacting the relevant OpDiv at the OpDiv's mailing
address, email address, and/or telephone number shown in the System
Location section, above.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Federal Advisory Committee Act (FACA), 5 U.S.C. 1001 et seq. See
also 5 U.S.C. 1004(b)(3) (FDA-specific authority) and 42 U.S.C.
282(b)(16) (NIH-specific authority).
PURPOSE(S) OF THE SYSTEM:
Records in this system of records are used in the administration
and management of Federal advisory committees (including any subgroups
of same) in the Department, including for these specific purposes:
Records about members or prospective members of a Federal
advisory committee or subgroup are used (1) in the preparation of
reports; quarterly alphabetical listings of past, present, and
recommended members; lists of vacancies, acceptances, and separations;
and documentation of nominations; (2) to identify the most qualified
applicants and ensure that the makeup of the committee, subcommittee,
or working group is sufficiently balanced and diverse (see 41 CFR part
102-3.30(c)); (3) to ensure compliance with ethics and conflict-of-
interest requirements; and (4) to communicate with the members about
committee or subgroup activities.
Records about guest speakers are used to determine whether
the speakers will be invited to give a presentation on the matter in
question and to inform the committee members of the speakers'
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qualifications and/or financial interests and professional
relationships pertaining to the matter before the committee, so that
the members can objectively evaluate each speaker's presentation.
Records about subscribers (members of the public who
subscribe to receive publications or other information issued or posted
by a particular Federal advisory committee) are used for the purpose of
maintaining the subscriber list (i.e., to add, update, or remove a
subscriber's contact information when requested by that individual) and
may also be used to indicate if a particular subscriber needs to
receive information in a particular format, as a reasonable
accommodation, in order to provide information to that subscriber in
that format.
Records about registrants (members of the public who
register as attendees for in-person and web-based Federal advisory
committee meetings) are used for the purpose of maintaining the meeting
registration lists and may also be used to indicate if a particular
registrant needs a sign language interpreter, wheelchair access, or
other accommodation to participate in a meeting.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The records are about these categories of individuals:
Committee members. Individuals who have been or presently
are members of, or are being considered for, membership on a Federal
advisory committee within the jurisdiction of HHS. Individuals may be
appointed to serve on an advisory committee as a FGE pursuant to 42 CFR
102-3.130(a); as a NIH peer review consultant as authorized by 42
U.S.C. 282(b)(16); as a SGE pursuant to 5 U.S.C. 3109; or as a
representative member when directed by statute or regulation (see, for
example, 21 U.S.C. 360c(b) regarding representative members of FDA
device panels, and 21 CFR 14.84 regarding representative members of
standing technical advisory committees who represent consumer and
industry interests).
Subcommittee and working group members (some may also be
committee members, covered in the preceding category).
Guest speakers. Individuals whose professional background
or other qualifications are checked and/or who are screened for
possible conflicts of interest (financial interests and professional
relationships) related to a matter they wish to speak on before an HHS
Federal advisory committee (they may be non-Federal government
employees or special government employees acting in a non-official,
non-governmental capacity).
Subscribers. Individual members of the public who have
asked to be included in a Federal advisory committee mailing or
emailing list to receive publications and other information from the
committee.
Meeting registrants. Individual members of the public who
register to attend public Federal advisory committee meetings.
CATEGORIES OF RECORDS IN THE SYSTEM:
The categories of records are:
Records about members and prospective members of HHS
Federal advisory committees. These records consist of membership
records, accountability records, and management records, containing
name and other data such as the following about each member or
prospective member: title, gender, place and date of birth, contact
information (e.g., home address, business address, telephone number,
email address), contact information for any assistant or organization
contact assisting the member or prospective member, organizational
affiliation, degrees held, general educational background, ethnic
background, resume, curriculum vitae, dates of term on advisory
committee, status on advisory committee, reason for leaving advisory
committee, indication of previous or current membership on other
advisory committees, special qualifications for the advisory committee
membership, source or references who recommended the individual for
membership on advisory committee, copies of any forms filed with the
Office of Government Ethics (OGE) such as OGE Form 450, and
miscellaneous correspondence. Additionally, memoranda justifying the
individual's selection are included in the file if the individual
doesn't meet certain statutory or other requirements for advisory
committee membership (for example, where the individual has served
repetitively on advisory committees and a policy requires a break in
service).
Records about members or prospective members of HHS
Federal advisory committee working groups or subcommittees (subgroups).
These records are similar to, but not co-extensive with, records about
members and prospective members of committees, described above (for
example, the OGE Form 450 isn't completed by subgroup members and
prospective members unless they are also committee members or
prospective members).
Records about guest speakers. These consist of the
completed disclosure form, containing the individual's identifying
information and information about the individual's financial interests
and professional relationships (such as: name, Federal employment
status, securities held, contracts, grants, consulting, and
professional relationships such as those with an employer, firm,
organization or a person in the individual's professional network); and
internal and external correspondence and associated information
compiled by the agency in reviewing the disclosures.
Records about subscribers. Such records typically are
limited to the individual's name and mailing address or email address
and, if applicable, preferred format.
Records about meeting registrants. Such records include
the individual's contact information and, if applicable, reasonable
accommodation requests. Demographic information may also be included,
if the particular registration form requests it.
RECORD SOURCE CATEGORIES:
All information about a subscriber or meeting registrant is
obtained directly from that individual. The vast majority of
information about a committee member or prospective member, or a
subcommittee or working group member or prospective member, is obtained
directly from that individual, or from the individual's administrative
assistant or organization contact; other information in the form of
references and recommendations is obtained from other private
individuals, program personnel, biographical reference books, private
organizations, former employers, regional offices of HHS, Members of
Congress, and other government sources. Information about a prospective
guest speaker is provided directly by the individual or is derived or
obtained from materials supplied by the individual, from observation
and analysis made by agency staff, from correspondence between the
agency and the individual, and from any other relevant source necessary
to conduct a complete a review of the individual's disclosed
qualifications and/or interests.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND PURPOSES OF SUCH USES:
In addition to other disclosures which are authorized directly in
the Privacy Act statute at 5 U.S.C. 552a(b), information about a
subject individual may be disclosed from this system of records to non-
HHS officers and employees, without the subject
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individual's consent, as provided in these routine uses which are
published pursuant to 5 U.S.C. 552a(b)(3):
1. Records about committee members and guest speakers may be
disclosed to GSA when HHS enters and uploads committee information and
records in GSA's facadatabase.gov system, for the purpose of keeping
Congress and the public informed of the existence, membership, and
activities of advisory committees as authorized by the FACA at 5 U.S.C.
1002(b)(5). Committee member names are also disclosed in administrative
reports to the President and OMB.
2. HHS may publicly disclose the names of and limited information
about qualifications (e.g., professional backgrounds) and financial
disclosures of members of HHS Federal advisory committees,
subcommittees, and working groups, and about guest speakers, on its
websites and in facadatabase.gov. Information made public will be
limited to information that HHS would be required to release to a
requester under FOIA; meaning, information that would not result in a
clearly unwarranted invasion of privacy.
3. Relevant records may be disclosed to appropriate Federal, State,
local, or Tribal agencies; international agencies; or foreign
governments responsible for investigating, prosecuting, enforcing, or
implementing statutes, rules, regulations, or orders, when HHS becomes
aware of evidence of a potential violation of civil or criminal law. In
most cases, these disclosures will be made after first referring the
information to another HHS component, such as the HHS Office of the
General Counsel or the HHS Office of the Inspector General, to
determine if the information is appropriate to refer to an outside law
enforcement or other appropriate agency; if that component makes the
disclosure to an outside agency, the equivalent routine use published
in that component's SORN would apply instead of this routine use.
4. Records may be disclosed to DOJ or to a court or other
adjudicative body in litigation or other adjudicative proceedings when
HHS or any of its components, or any employee of HHS in his or her
official capacity, or any employee of HHS in his or her individual
capacity where the DOJ or HHS has agreed to represent the employee, or
the United States, 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.
5. Disclosure may be made 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 that individual.
6. Records may be disclosed to student volunteers, individuals
working under a personal services contract, and other individuals
performing functions for the Department but technically not having the
status of agency employees, if they need to access the records in order
to perform their assigned agency functions.
7. Disclosures may be made to Federal agencies and HHS contractors
that have been engaged by HHS to assist in accomplishment of an HHS
function relating to the purposes of this system of records (including
ancillary functions, such as compiling reports and evaluating program
effectiveness and contractor performance) and that have a need to have
access to the records in order to assist HHS in performing the
activity. Any contractor will be required to comply with the
requirements of the Privacy Act.
8. Records may be disclosed to the Chairperson or Vice Chairperson
of the relevant advisory committee to use for purposes such as
determining membership on subcommittees, assigning tasks to members,
and distributing information to members for meeting or other committee
work purposes.
9. Records may be disclosed to the Executive Office of the
President, the Office of Management and Budget, or other agencies for
coordination on advisory committee member selection.
10. Records about a member or prospective member or guest speaker
may be disclosed to any source from which additional information is
requested by HHS (to the extent necessary to identify the individual,
inform the source of the purpose of the request, and identify the type
of information requested) when necessary to obtain information relevant
to an HHS decision involving the individual.
11. Records may be disclosed to a Federal, foreign, State, local,
Tribal, or other public authority of the fact that this system of
records contains information relevant to that entity's decision
regarding hiring or retention of an employee, retention of a security
clearance, letting of a contract, or issuance or retention of a
license, grant or other benefit, so that it may then make a request
supported by the written consent of the individual for further
information if it so chooses. HHS will not make an initial disclosure
unless the information has been determined to be sufficiently reliable
to support a referral to another office within the agency or to another
Federal agency for criminal, civil, administrative, personnel, or
regulatory action.
12. HHS may disclose records from this system of records to NARA,
GSA, or other relevant Federal agencies in connection with records
management inspections conducted under the authority of 44 U.S.C. 2904
and 2906.
13. Records may be disclosed to Federal agencies and entities
(e.g., the Office of Government Ethics, the Government Accountability
Office, or the General Services Administration) for program evaluation
and assessment purposes, if disclosure of identifiable records is
deemed appropriate by HHS counsel.
14. Records may be disclosed to 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.
15. Disclosures may be made to appropriate agencies, entities, and
persons when (1) HHS suspects or has confirmed that there has been a
breach of the system of records; (2) HHS has determined that as a
result of the suspected or confirmed breach there is a risk of harm to
individuals, HHS (including its information systems, programs, and
operations), the Federal Government, or national security; and (3) the
disclosure made to such agencies, entities, and persons is reasonably
necessary to assist in connection with HHS efforts to respond to the
suspected or confirmed breach or to prevent, minimize, or remedy such
harm.
16. Disclosure may be made to another Federal agency or Federal
entity, when HHS determines that information from this system of
records is reasonably necessary to assist the recipient agency or
entity in (1) responding to a suspected or confirmed breach or (2)
preventing, minimizing, or remedying the risk of harm to individuals,
the recipient agency or entity (including its information systems,
programs, and operations), the Federal Government, or national
security, resulting from a suspected or confirmed breach.
POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
Records are stored in hard-copy files and on electronic media.
POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
Records are retrieved by the subject individual's name, with the
exception of
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records about subscribers, which are retrieved by the subscriber's name
or email address.
POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
Records about individuals who serve as members of Federal advisory
committees and subgroups are retained and disposed of in accordance
with NARA General Records Schedule (GRS) 6.2, Items 010, 040, and 050:
Item 010 Substantive Committee Records requires
substantive records related to committee and subgroup membership to be
accessioned to the National Archives for permanent retention when the
records are 15 years old or older or upon termination of the committee,
whichever is sooner.
Item 040 Committee Accountability Records (note that this
item excludes forms filed under the Ethics in Government Act, and such
forms are not covered by this SORN) authorizes accountability records
(such as records about members' financial disclosures and conflicts of
interest, and records documenting travel and other payments to or for
committee members) to be destroyed when 6 years old unless longer
retention is required for business use.
Item 050 Non-substantive Committee Records authorizes
records of an administrative nature, such as those documenting members'
and prospective members' credentials, to be destroyed when superseded,
obsolete, or no longer needed, or upon termination of the committee,
whichever is sooner.
Records about prospective members of Federal advisory committees
are retained and disposed of in accordance with GRS 6.2, Item 050 (see
above).
Records about guest speakers are disposed of in accordance with GRS
6.2, Item 040 (see above).
Records about meeting registrants and subscribers are retained and
disposed of in accordance with GRS 6.5, Item 020, which authorizes
sign-up forms and distribution lists for distributing information such
as publications and data produced by the agency to be deleted when
superseded or obsolete or when the customer requests the agency to
remove the records.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
Records are protected from unauthorized access through appropriate
administrative, physical, and technical safeguards. Safeguards conform
to the HHS Information Security and Privacy Program, https://www.hhs.gov/ocio/securityprivacy/. The safeguards include protecting
the facilities where records are stored or accessed with security
guards, badges, and cameras; securing hard-copy records in locked file
cabinets, file rooms or offices during off-duty hours; limiting access
to electronic databases to authorized users based on roles, the
principle of least privilege, and either two-factor authentication or
user ID and password; using a secured operating system protected by
encryption, firewalls, and intrusion detection systems; encrypting data
transmissions and records stored on removable media; using secure
destruction methods prescribed in National Institute of Standards and
Technology Special Publication 800-88 to dispose of eligible records;
and training personnel in Privacy Act and information security
requirements.
RECORD ACCESS PROCEDURES:
An individual seeking access to records about him or her in this
system of records must submit a written access request to the relevant
System Manager, at the address indicated in the ``System Manager(s)''
section, above, in accordance with the Department's Privacy Act
implementation regulations in 45 CFR. The request must contain the
individual's full name and address, and, for identity verification
purposes, signature, and date and place of birth. In addition, to
verify the individual's identity, the individual must provide either a
notarized request or a written certification that the individual is who
he or she claims to be and understands that the knowing and willful
request for acquisition of a record pertaining to an individual under
false pretenses is a criminal offense under the Privacy Act, subject to
a fine of up to $5,000.
CONTESTING RECORD PROCEDURES:
An individual seeking to amend a record about him or her in this
system of records must submit a written amendment request to the
relevant System Manager, at the address indicated in the ``System
Manager(s)'' section, above, in accordance with the Department's
Privacy Act implementation regulations in 45 CFR. The request must
contain the same information required for an access request, and must
reasonably identify the record, specify the information contested,
state the corrective action sought, provide the reasons for the
amendment, and include any supporting justification or documentation.
The individual must verify his or her identity in the same manner
required for an access request. The right to contest records is limited
to information that is factually inaccurate, incomplete, irrelevant, or
untimely (obsolete).
NOTIFICATION PROCEDURES:
An individual who wishes to know if this system of records contains
records about him or her must submit a written notification request to
the relevant System Manager at the address indicated in the ``System
Manager(s)'' section, above, in accordance with the Department's
Privacy Act implementation regulations in 45 CFR. The request must
contain the same information required for an access request, and the
individual must verify his or her identity in the same manner required
for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
47 FR 45514 (October 13, 1982); 59 FR 55845 (November 9, 1994); 83
FR 6591 (February 14, 2018).
Dated: December 13, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30782 Filed 12-23-24; 8:45 am]
BILLING CODE 4164-01-P