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 

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 

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 

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. 

• 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 

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. 

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, 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 

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. 

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, 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). 

• 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices 105059 

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 

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. 

ACTION: Notice; request for information; 

extension of comment period. 

SUMMARY: 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). 


ddrumheller on DSK120RN23PROD with NOTICES1