Statement of Organization, Functions, and Delegations of Authority

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Published

September 29, 2026

Issuing agencies

Health and Human Services Department

Abstract

This document revises and restates the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Office of the General Counsel (OGC). Issuance of this Statement of Organization rescinds all prior Statements of Organization.

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<title>Federal Register, Volume 91 Issue 187 (Tuesday, September 29, 2026)</title>
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[Federal Register Volume 91, Number 187 (Tuesday, September 29, 2026)]
[Notices]
[Pages 61422-61426]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19903]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Statement of Organization, Functions, and Delegations of
Authority

AGENCY: Office of the General Counsel, Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: This document revises and restates the Statement of
Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services, Office of the General Counsel
(OGC). Issuance of this Statement of Organization rescinds all prior
Statements of Organization.

FOR FURTHER INFORMATION CONTACT: Robert Fox Foster, Acting General
Counsel, Office of the General Counsel, Office of the Secretary, 200
Independence Avenue SW, Washington, DC 20201. (202) 690-8454.

SUPPLEMENTARY INFORMATION: The Office of the Secretary (OS) Statement
of Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services, Office of the General Counsel
(OGC), should now read as follows:

Section I. Mission

The General Counsel is responsible for providing all legal services
and advice to the Secretary, Deputy Secretary, and all subordinate
organizational components of the Department, which legal advice, to the
maximum extent permitted under Executive Order 14215 (Feb. 18, 2025),
shall be binding on the Department unless overturned by the Secretary.
Under direction of the General Counsel, the Office of the General
Counsel (OGC) serves as the sole officially designated source of legal
advice and services to the Department's operating and staff divisions
(except the OIG) to ensure that all the operating and staff divisions
receive uniform advice. OIG is authorized to have its own Office of the
Counsel to the Inspector General (OCIG) with respect to matters solely
within the OIG's jurisdiction. See 62 FR 30859 (June 5, 1997).

Section II. Organization and Leadership

The Office of the General Counsel, under the supervision of the
General Counsel, consists of the Immediate Office and Divisions. OGC
may maintain satellite offices as duty locations for attorneys and
staff assigned to one or more Divisions. Satellite offices are not
separate organizational components of OGC.

Subsection A. The Immediate Office of the General Counsel

1. The Immediate Office of the General Counsel
The Immediate Office of the General Counsel consists of the General
Counsel, his or her executive assistant(s), a Principal Deputy General
Counsel, such other Deputy General Counsel as the Secretary deems
appropriate and appoints, such other Special Assistant Deputy General
Counsel, Senior

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Counsel, Counsel, Senior Advisors and attorneys and staff as the
General Counsel deems appropriate, the Office of Legal Resources (OLR),
and the Legislation Section (GCL).
a. The General Counsel. The General Counsel is the chief legal
officer of the Department and is directly responsible to the Secretary.
b. Principal Deputy General Counsel. The Principal Deputy General
Counsel is the second-ranking legal officer of the Department and is
usually a non-career inferior officer appointed by the Secretary and is
directly responsible to the General Counsel and the Secretary.
c. Deputy General Counsel. The Deputy General Counsel report to the
General Counsel and each shall be responsible for overseeing such
substantive legal areas and corresponding OGC portfolios as designated
by the General Counsel. Deputy General Counsel may be assigned
oversight of one or more portfolios within the Office of the General
Counsel. In addition, certain Deputy General Counsel may generally be
responsible for OGC management and operations, oversight of OLR, and
such litigation, substantive, or programmatic portfolios and other
duties as determined by the General Counsel. For performance evaluation
purposes, it is OGC's policy that, when feasible, a career Deputy
General Counsel will be assigned to serve as the rating official for
all career Associate General Counsel, Chief Counsel, the OLR Director,
and any career Senior Counsel or Senior Advisor.
d. Chief Legal Officer for the Centers for Medicare & Medicaid
Services (CMS). The Chief Legal Officer for CMS is a Deputy General
Counsel and is the principal legal officer for CMS and reports to the
General Counsel. The Chief Legal Officer is responsible for overseeing
the provision of legal services to CMS. The Chief Legal Officer shall
be responsible for such substantive, litigation, programmatic,
management, and other legal matters relating to CMS as determined by
the General Counsel.
e. Chief Counsel, Food and Drug Administration. The Chief Counsel
of the Food and Drug Administration (FDA) is an Associate General
Counsel, serves as the principal legal officer for FDA, and reports to
the General Counsel. The Chief Counsel heads the Office of the Chief
Counsel, also known as the Food and Drug Division of the Office of the
General Counsel. Consistent with 21 CFR 5.1105, the Office of the Chief
Counsel is administratively within the Office of the Commissioner of
Food and Drugs but is part of the Office of the General Counsel.
Subject to the direction of the General Counsel, the Chief Counsel
oversees the provision of legal services to FDA and performs the
functions assigned to the Chief Counsel under applicable law, including
designating and supervising Office of the General Counsel attorneys who
represent FDA components or advise the Commissioner in administrative
proceedings, consistent with applicable separation-of-functions
requirements.
f. Special Assistant Deputy General Counsel. The General Counsel
may designate one or more attorneys to act as a special assistant and
to carry the title Special Assistant Deputy General Counsel. Any
Special Assistant Deputy General Counsel shall report directly to the
General Counsel or to such Deputy General Counsel as the General
Counsel may designate.
g. Senior Counsel, Special Counsel, Counsel, or Senior Advisor to
the General Counsel: Senior Counsel, Special Counsel, Counsel, or
Senior Advisor to the General Counsel perform such duties as may be
assigned to them by the General Counsel, Principal Deputy General
Counsel, or Deputy General Counsel.
2. Order of Succession
a. General Counsel Vacancy. In the event of a ``vacancy'' in the
position of General Counsel as a result of death, resignation, or an
inability to perform the functions and duties of the office, the
Principal Deputy General Counsel shall serve as the Acting General
Counsel as dictated by the Federal Vacancies Reform Act of 1998, 5
U.S.C. 3345 et seq., unless the President designates another Acting
General Counsel pursuant to the Act.
b. Principal Deputy General Counsel Vacancy. In the event of
vacancies in offices of both the General Counsel and the Principal
Deputy General Counsel, the Deputy General Counsel with the greatest
seniority in that position shall perform the functions of or serve as
the Acting General Counsel as dictated by the Federal Vacancies Reform
Act of 1998, unless the President designates another Acting General
Counsel pursuant to the Act.
3. The Office of Legal Resources, Immediate Office of the General
Counsel
The Office of Legal Resources (OLR) shall be headed by a Director,
who is responsible for providing personnel, budget, correspondence, and
information technology support to the Office of the General Counsel as
well as providing legal information law services through the Law
Library. The Office of Legal Resources includes six branches, each
headed by a Director or Manager:
a. Budget.
b. Correspondence.
c. Human Capital Services.
d. Information Technology.
e. Legal Information.
f. Procurement, Policy and Planning.
4. The Legislation Section, Immediate Office of the General Counsel
The Legislation Section is a component of the Immediate Office. The
Section shall be headed by a Senior Counsel for Legislation, who
reports to the General Counsel through such Deputy General Counsel as
the General Counsel may designate.

Subsection B. Divisions

Each OGC Division is under the general supervision of the General
Counsel. Each OGC Division head reports directly to the designated
Deputy General Counsel on substantive legal matters, litigation
strategy, and other matters as directed by the General Counsel. There
are 11 divisions in the Office of the General Counsel:
1. The Advanced Research Projects Agency for Health (ARPA-H)
Division shall be headed by a Chief Counsel/Associate General Counsel,
who reports to the General Counsel through a designated Deputy General
Counsel.
2. The Centers for Medicare & Medicaid Services Division (CMSD)
shall be headed by an Associate General Counsel, who reports to the
General Counsel through the Chief Legal Officer for CMS. The Division
consists of four groups, each headed by at least one Deputy Associate
General Counsel, and a Principal Deputy Associate General Counsel,
reporting to the Associate General Counsel:
a. Litigation Group.
b. Program Review Group.
c. Program Integrity Group.
d. Program Enforcement Group.
The Associate General Counsel may designate supervisory attorneys
to report to the Deputy Associate General Counsel as appropriate.
3. The Children, Families, and Aging Division (CFAD) shall be
headed by an Associate General Counsel, who reports to the General
Counsel through a designated Deputy General Counsel.
CFAD also includes a Deputy Associate General Counsel, who reports
to the Associate General Counsel. The Associate General Counsel may
designate supervisory attorneys to report to the Deputy Associate
General Counsel as appropriate.
4. The Civil Rights and Health Information Privacy Division (CPD)
shall be headed by an Associate General

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Counsel, who reports to the General Counsel through a designated Deputy
General Counsel. The Division consists of two branches, each headed by
a Deputy Associate General Counsel who reports to the Associate General
Counsel:
a. Civil Rights Branch.
b. Health Information Privacy Branch.
5. The Ethics Division (ETH) shall be headed by an Associate
General Counsel, who reports to the General Counsel through a
designated Deputy General Counsel. The Division consists of two
branches, each headed by a Deputy Associate General Counsel reporting
to the Associate General Counsel:
a. Ethics Advice and Policy Branch.
b. Ethics Program Administration Branch.
The Associate General Counsel and Deputy Associate General Counsel
for Ethics Advice and Policy simultaneously serve by secretarial
delegation as the Department's Designated Agency Ethics Official and
Alternate Designated Agency Ethics Official, respectively.
6. The Food and Drug Division (FDD)--also known as the Office of
the Chief Counsel--is headed by the Chief Counsel identified in
II.A.1.d. The Division consists of two branches, each of which is
headed by one or more Deputy Associate General Counsel who report to
the Chief Counsel:
a. Litigation Branch.
b. Program Review Branch.
7. The General Law Division (GLD) shall be headed by an Associate
General Counsel, who reports to the General Counsel through a
designated Deputy General Counsel. The Division consists of two
branches, each headed by a Deputy Associate General Counsel reporting
to the Associate General Counsel, as well as Assistant Deputy Associate
General Counsel selected by the Associate General Counsel to provide
oversight and supervision of Sections within the Division:
a. Claims and Employment Law Branch.
b. Procurement, Fiscal, and Information Law Branch.
8. The Disease Prevention and Health Information Technology
Division (DPTD) shall be headed by an Associate General Counsel, who
reports to the General Counsel through a designated Deputy General
Counsel. The Division may also have a designated Deputy Associate
General Counsel. The Division consists of four sections, each reporting
to the Associate General Counsel:
a. Global Affairs Section.
b. Health Information Technology Section.
c. Preparedness and Response Section.
d. Public and Environmental Health Section.
The General Counsel may designate an attorney from this Division to
serve as the primary and responsible legal advisor to the Director of
the Centers for Disease Control and Prevention (CDC), who may be
designated the Chief Legal Officer for the CDC.
9. The Public Health Division (Ph.D.) shall be headed by an
Associate General Counsel, who reports to the General Counsel through a
designated Deputy General Counsel. The Division consists of three
branches, each of which is headed by a Deputy Associate General Counsel
reporting to the Associate General Counsel:
a. Indian Health Service (IHS) Branch.
b. National Institutes of Health (NIH) Branch.
c. Public Health and Science Branch.
10. The National Complex Litigation and Investigations Division
(NCLID) shall be headed by an Associate General Counsel, who reports to
the General Counsel through a designated Deputy General Counsel. The
Division shall also have a designated Deputy Associate General Counsel
for E-Discovery, who reports to the Associate General Counsel.
11. The Unaccompanied Alien Children Legal Representation Division
(UACLRD) shall be headed by an Associate General Counsel, who reports
to the General Counsel through a designated Deputy General Counsel. The
Division operates as a legal service provider for unaccompanied alien
children. The Division shall be separate and distinct from the
Children, Families, and Aging Division and shall not provide legal
advice or representation to the Administration for Children and
Families or the Office of Refugee Resettlement with respect to matters
in which the Division provides legal advice, counsel, or representation
to an unaccompanied alien child. The Associate General Counsel may
designate supervisory attorneys to provide oversight and supervision of
attorneys and staff within the Division, as appropriate.

Subsection C. Satellite Offices

The General Counsel may establish satellite offices at locations
designated by the General Counsel. Attorneys and staff assigned to a
satellite office remain assigned to their respective Divisions and
subject to the operational, professional, and substantive supervision
of the General Counsel through applicable Division leadership and
designated Deputy General Counsel.
The General Counsel may designate a senior attorney as a Managing
Counsel at a satellite office to provide limited, site-specific
administrative oversight, including oversight of facilities, space,
security, and other shared administrative matters. Such designation
does not confer authority to assign or direct legal work, supervise or
evaluate personnel, establish litigation or legal positions, or
otherwise exercise operational, professional, or substantive oversight,
except pursuant to a separate written delegation.

Section III. Functions

Subsection A. The General Counsel and the Office of the General Counsel

1. The General Counsel. The General Counsel is authorized to
promulgate such directives and issue such legal opinions as may be
necessary to carry out the responsibilities of the Office. The General
Counsel, directly or through attorneys in the Office of the General
Counsel, undertakes the following activities unless an applicable
statute provides otherwise or the General Counsel has delegated the
responsibility elsewhere:
a. Furnishes all legal services and advice to the Secretary, Deputy
Secretary, and all offices, branches, and units of the Department in
connection with the operations and administration of the Department and
its programs, unless otherwise expressly delegated by statute to
another agency or official.
b. Furnishes legal services and advice on such other matters as may
be submitted by the Secretary, the Deputy Secretary, any other senior
leaders, and other persons authorized by the Secretary to request such
service or advice.
c. Represents the Department in all litigation when such direct
representation is not precluded by law, and in other cases, supervises
the conduct of such litigation.
d. Acts as the Department's representative in communicating with
the Department of Justice, including all United States Attorneys, on
all civil and criminal matters.
e. Acts as the Department's representative in communicating with
Office of White House Counsel and the Offices of General Counsel for
any other Department or Agency.
f. Authorizes indemnification of Department employees, as
appropriate, pursuant to 45 CFR part 36.
g. Oversees the Department's legal review of proposed Federal
legislation and prescribes Department-wide

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procedures for routing and reviewing legislative materials.
h. Supervises all legal activities of the Department and its
operating and staff divisions, except with respect to certain matters
within the jurisdiction of the OIG.
i. Ensures that no one in the Department, other than those in OGC
or expressly authorized by the General Counsel to do so, provides any
legal advice to anyone in the Department that implies that they are
functioning as a departmental lawyer.
j. Issues all Advisory Opinions except those relating to the Anti-
Kickback Act (SSA 1128B(b)), the Anti-Inducement Act (SSA 1128A(a)(5)),
and the Ethics in Patient Referral Act of 1989.
2. The Legislation Section (GCL). The Legislation Section:
a. Drafts all proposed legislation originating in the Department,
reviews specifications for such proposed legislation, and reviews all
proposed Federal legislation submitted to the Department or any
constituent unit of the Department for comment.
b. Prepares or reviews reports and letters to congressional
committees, the Office of Management and Budget, and others concerning
proposed Federal legislation.
c. Reviews proposed testimony of Department officials before
congressional committees relating to proposed Federal legislation.
d. Acts as the Department's liaison with the Office of Management
and Budget on legislative matters.
e. Prescribes procedures governing the routing and review within
the Department of all materials relating to proposed Federal
legislation, including all such materials received by any constituent
unit of the Department.

Subsection B. Functions and Responsibilities of the OGC Divisions

The Divisions within OGC provide legal counsel to their clients, as
described below, subject to the professional supervision and control of
the General Counsel and the designated Deputy General Counsel.
1. The Advanced Research Projects Agency for Health (ARPA-H)
Division. The ARPA-H Division provides legal services to ARPA-H.
2. Centers for Medicare & Medicaid Services Division (CMSD). CMSD
provides legal services to the Centers for Medicare & Medicaid Services
(CMS), the Office of Medicare Hearings and Appeals (OMHA) and the
Departmental Appeals Board (DAB). CMSD also represents CMS in
connection with certain administrative and judicial proceedings
involving programs administered by CMS, provides legal guidance for
programs administered by CMS, and reviews proposed and final
regulations and Federal Register notices prepared by CMS. CMSD acts as
the primary liaison to the Department of Justice and other federal
departments for programs administered by CMS.
3. Children, Families, and Aging Division (CFAD). CFAD provides
legal services to the Administration for Children and Families and its
various agencies, including the Office of Refugee Resettlement and
Administration for Community Living. In addition, the Division advises
the Department on initiatives authorized by the Indian Employment,
Training, and Related Services Demonstration Act of 2017.
4. Civil Rights and Health Information Privacy Division (CPD). CPD
provides legal services to the Office for Civil Rights (OCR) and
advises on the implementation and enforcement of civil rights laws,
conscience and religious freedom laws, and health information privacy
laws, including e.g., the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) and 42 CFR part 2. CPD does not
defend claims filed by HHS employees.
5. Ethics Division (ETH). ETH administers and oversees Department-
wide implementation of comprehensive government ethics program
requirements under the Ethics in Government Act of 1978 as amended,
Executive Order 12731, and implementing regulations at 5 CFR part 2638.
This includes providing legal advice, training, and policy instruction
and guidance consistent with core ethics program elements, including
conflict of interest, impartiality, financial disclosure, outside
activities, political activity, lobbying, pre-clearance ethics
agreements, gifts, and travel payments from non-federal sources.
ETH also communicates on matters related to government ethics with
the Office of Counsel to the President, the Office of Government
Ethics, the Office of Special Counsel, the Office of Inspector General,
Special Investigations Unit, the Department of Justice, the Office of
Personnel Management, and the General Services Administration.
In addition, ETH develops component-specific conduct regulations
and implementing procedures.
6. Food and Drug Division (FDD). FDD acts as the legal advisor to
the Commissioner of Food and Drugs and provides legal services to the
Food and Drug Administration (FDA). This includes representing the FDA
in connection with judicial and administrative proceedings involving
programs administered by the FDA, providing legal advice and policy
guidance for programs administered by the FDA, and reviewing proposed
and final regulations and Federal Register notices prepared by FDA. FDD
acts as the Department and FDA's primary liaison to the Department of
Justice and other federal departments for programs administered by FDA;
all criminal prosecutions, investigations, and civil matters may be
referred to the Department of Justice only through or in consultation
with the Chief Counsel, appropriate Deputy General Counsel or the
General Counsel.
7. General Law Division (GLD). GLD provides advice and
representation with respect to laws and regulations that are applicable
Government-wide including laws and regulations that govern business
management activities and administrative operations such as
procurement, contracting, personnel, budget, appropriations, federal
real property, employment, information disclosure and privacy (but not
health information privacy) and federal tort claims. In addition, the
Associate General Counsel for GLD acts as the Department Claims Officer
unless otherwise determined by the Secretary.
8. National Complex Litigation and Investigations Division (NCLID).
NCLID provides legal services to all agencies and offices within the
Department, as directed by the General Counsel. NCLID provides legal
services in connection with complex litigation or anticipated complex
litigation by or against the Department. Such litigation may include
cases for which other OGC divisions request NCLID participation, cases
spanning multiple OGC divisions, or cases outside the scope of other
OGC divisions. NCLID administers the OGC-wide E-discovery program and
coordinates the use of E-discovery technology with agencies and offices
within the Department. NCLID will also conduct internal investigations
at the request of the Secretary, Deputy Secretary, or the General
Counsel.
9. The Disease Prevention and Health Information Technology
Division (DPTD) provides legal services to the Centers for Disease
Control and Prevention (CDC), the Agency for Toxic Substances and
Disease Registry (ATSDR), the Office of the National Coordinator for
Health Information Technology (ONC), and the Administration for
Strategic Preparedness and Response (ASPR). DPTD also provides legal
services to the Office of Global Affairs (OGA) and the

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Office of the Assistant Secretary for Planning and Evaluation (ASPE).
The Public and Environmental Health Section provides legal services
to CDC and ATSDR concerning public-health, disease-control, quarantine
and isolation, emergency-response, environmental-health, occupational
safety and worker health, and hazardous-substance authorities.
The Health Information Technology Section advises ONC concerning
its authorities under the HITECH Act, the 21st Century Cures Act, the
Public Health Service Act, and related statutes.
The Global Affairs Section advises OGA and the CDC's Global Health
Center concerning global health, international public health engagement
and activities, and such additional functions in the international
space as may be assigned by the General Counsel.
The Preparedness and Response Section advises ASPR concerning
emergency preparedness and response authorities; public-health
emergency declarations and waivers; the Public Readiness and Emergency
Preparedness Act; medical countermeasures; the Biomedical Advanced
Research and Development Authority; and the Strategic National
Stockpile.
10. Public Health Division (Ph.D.). Ph.D. provides legal services
to all Public Health Service agencies and programs not otherwise
assigned to another OGC Division, including, but not limited to (i) the
Office of the Assistant Secretary for Health, and its various programs,
including the Office of the Surgeon General and the Commissioned Corps
of the U.S. Public Health Service; (ii) the Office of the Secretary's
Office of Minority Health; (iii) the National Institutes of Health;
(iv) the Health Resources and Services Administration; (v) the Indian
Health Service; (vi) the Agency for Healthcare Research and Quality;
and (vii) the Substance Abuse and Mental Health Services
Administration.
11. Unaccompanied Alien Children Legal Representation Division
(UACLRD). UACLRD provides direct legal services to unaccompanied alien
children (UAC). Attorneys within UACLRD provide direct legal advice and
counsel to UAC; provide introductory legal orientation concerning
immigration proceedings and applicable processes, rights, and
responsibilities; and represent individual UAC as counsel in
immigration proceedings, including by entering appearances on behalf of
UAC before immigration courts and other appropriate immigration
adjudicatory bodies. UACLRD attorneys may provide such representation
throughout the course of an individual UAC's immigration proceedings,
as appropriate.
UACLRD performs these functions independently of the Children,
Families, and Aging Division, the Administration for Children and
Families, and the Office of Refugee Resettlement. UACLRD does not
provide legal advice or representation to those entities with respect
to matters in which UACLRD represents an individual UAC. The Division
may coordinate with other OGC components and appropriate Federal
entities as necessary to carry out its responsibilities, consistent
with its professional responsibilities to the UAC whom its attorneys
represent.

Robert F. Kennedy, Jr.,
Secretary, U.S. Health and Human Services.
[FR Doc. 2026-19903 Filed 9-28-26; 8:45 am]
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