[Federal Register Volume 90, Number 49 (Friday, March 14, 2025)]
[Notices]
[Pages 12166-12169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04130]
[[Page 12166]]
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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: Sean Keveney 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 a
General Counsel, consists of:
1. Immediate Office
2. Divisions
3. Regional Offices
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 Counsel, Counsel, Senior Advisors and attorneys and
staff as the General Counsel deems appropriate, and the Office of Legal
Resources (OLR).
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.
i. Chief Counsel for Food, Research, and Drugs. One Deputy General
Counsel will be appointed as the Chief Counsel for Food, Research, and
Drugs and will be responsible for supervising the Associate General
Counsel, and their staff, who provide legal services to the National
Institutes of Health and the Food and Drug Administration.
ii. 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.
d. Senior Counsel, Special Counsel, Counsel, or Senior Advisor to
the General Counsel: Senior Counsel, Special Counsel, Counsel, or
Senior Advisors to the General Counsel perform such duties as may be
assigned to them by the General Counsel, Principal Deputy General
Counsel, Deputy General Counsel, or Chief Counsel for Food, Research,
and Drugs.
2. Order of Succession
a. General Counsel Vacancy. In the event of the General Counsel's
absence, or 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 act in the General Counsel's stead, or serve as the
Acting General Counsel as dictated by the Vacancies Reform Act of 1998,
5 U.S.C. 3345 et seq.
b. Principal Deputy General Counsel Vacancy. In the event of the
absence of or 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 Vacancies Reform
Act of 1998.
3. The Office of Legal Resources, Immediate Office of the General
Counsel
The Office of Legal Resources 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
Subsection B. Divisions
Each OGC Division is under the general supervision of the General
Counsel. Each OGC office head reports directly to the designated Deputy
General Counsel on substantive legal matters, litigation strategy, and
other matters as directed by the General Counsel. The OGC office heads
who provide legal services to the National Institutes of Health and the
Food and Drug Administration will report directly
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to the Chief Counsel for Food, Research, and Drugs. There are ten
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 a designated Deputy General Counsel. The
Division consists of three groups each headed by a Deputy Associate
General Counsel reporting to the Associate General Counsel:
a. Litigation Group
b. Program Review Group
c. Program Integrity 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, Privacy, and Technology Division (CRD) shall
be headed by an Associate General Counsel, who reports to the General
Counsel through a designated Deputy General Counsel. The Division will
be responsible for providing legal advice on all civil rights, health
policy, privacy, and related policy and enforcement matters in the
Department, with the exception of defending claims filed by employees
of HHS. The Division consists of two groups, each headed by a Deputy
Associate General Counsel who reports to the Associate General Counsel:
a. Civil Rights Branch
b. Health Information Privacy and Technology 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) shall be headed by a Chief
Counsel who shall be an Associate General Counsel and who shall report
directly to the Chief Counsel for Food, Research, and Drugs in the
Immediate Office of the General Counsel. The Division consists of two
branches, each of which is headed by one or more Deputy Associate
General Counsel who report to the Associate General 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 Legislation Division (GCL) shall be headed by an Associate
General Counsel, who reports to the General Counsel through a
designated Deputy General Counsel.
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 or the Chief Counsel for Food,
Research, and Drugs. The Division consists of four 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. Centers for Disease Control and Prevention Branch
c. National Institutes of Health Branch
d. 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.
Subsection C. Regional Offices
Each OGC Regional Office is under the general supervision of the
General Counsel. Each OGC office 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 four OGC regional offices:
1. OGC Region 1--Philadelphia shall be headed by a Chief Counsel,
who reports to the General Counsel through a designated Deputy General
Counsel. The office has a Deputy Chief Counsel, who reports to the
Chief Counsel.
2. OGC Region 2--Atlanta shall be headed by a Chief Counsel, who
reports to the General Counsel through a designated Deputy General
Counsel. The office consists of two branches, each of which is headed
by a Deputy Chief Counsel reporting to the Chief Counsel:
a. HHR Branch (Administration for Children and Families (ACF) and
Centers for Medicare & Medicaid Services (CMS) Program Advice and
Litigation
b. General Law Branch (Personnel and Contract Advice and Litigation)
3. OGC Region 3--Kansas City shall be headed by a Chief Counsel,
who reports to the General Counsel through a designated Deputy General
Counsel.
4. OGC Region 4--Denver shall be headed by a Chief Counsel, who
reports to the General Counsel through a designated Deputy General
Counsel. The office has a Deputy Chief Counsel, who reports to the
Chief Counsel.
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
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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. Provides legal review of all proposals for Federal legislation
originating within the Department, as well as all proposed Federal
legislation submitted to the Department or to any operating division of
the Department for comment; as appropriate, prepares or reviews reports
and letters to congressional committees, the Office of Management and
Budget, and others on proposed Federal legislation; and prescribes
procedures to govern the routing and review, within the Department, of
material relating to proposed Federal legislation.
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.
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).
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 the 477 initiative authorized by the Indian
Employment, Training, and Related Services Demonstration Act of 2017.
4. Civil Rights, Privacy, and Emerging Technology Division (CRD).
CRD provides legal services for the Office for Civil Rights (OCR) and
provides advice with respect to the enforcement of civil rights laws,
conscience statutes, the Health Insurance and Portability and
Accountability Act of 1996 (Social Security Act Sec. 1171 et seq.),
the Health Information Technology for Economic and Clinical Health
(HITECH) Act, and the rules implementing them with respect of HHS-
funded programs and activities. CRD also provides legal services to the
Assistant Secretary for Technology Policy and Office of the National
Coordinator for Health Information Technology (ASTP/ONC). CRD 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.
8. Legislation Division (GCL). GCL:
a. Drafts all proposed legislation originating in the Department,
reviews specifications for such proposed legislation, and reviews all
proposed legislation submitted to the Department or to 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 on proposed
legislation.
c. Reviews proposed testimony of Department officials before
congressional committees relating to pending or proposed legislation.
d. Acts as Department liaison with the Office of Management and
Budget on legislative matters.
e. Prescribes procedures to govern the routing and review, within
the Department, of material relating to proposed federal legislation.
9. National Complex Litigation and Investigation Division (NCLID).
NCLID provides legal services to all agencies and offices within the
Department, as
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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 or regional offices request NCLID participation,
cases spanning multiple OGC divisions or regional offices, or cases
outside the scope of other OGC divisions or regional offices. 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 General Counsel.
10. Public Health Division (Ph.D.). Ph.D. provides legal services
to all Public Health Service agencies (except to FDA) and their
programs, including the Office of the Surgeon General and the
Commissioned Corps of the U.S. Public Health Service. The represented
Public Health Service agencies include, but are not limited to: (i) the
Office of the Assistant Secretary for Health, and its various programs;
(ii) the Office of the Secretary's Office of Minority Health; (iii) the
Centers for Disease Control and Prevention; (iv) the National
Institutes of Health; (v) the Health Resources and Services
Administration; (vi) the Indian Health Service; (vii) the Substance
Abuse and Mental Health Services Administration; (viii) the Agency for
Healthcare Research and Quality, (ix) the Administration for Strategic
Preparedness and Response, and (x) the Agency for Toxic Substances and
Disease Registry.
Subsection C. Functions and Responsibilities of the OGC Regional
Offices
There are four OGC Regional Offices, each led by a Chief Counsel.
Regional offices within OGC provide a full range of legal services,
subject to the professional supervision and direction of the General
Counsel and the designated Deputy General Counsel. This includes
providing legal advice and representation in administrative and
judicial litigation regarding programs operated by the Centers for
Medicare and Medicaid Services, the Administration for Children and
Families, the Administration for Community Living, and Public Health
Service agencies including the Indian Health Service, the Health
Resources and Services Administration, the Substance Abuse and Mental
Health Services Administration, and the Centers for Disease Control and
Prevention; and providing legal advice and representation in
administrative and judicial litigation relating to business management
activities and administrative operations, such as employment and labor
relations, information disclosure and privacy, federal tort claims, and
suspensions, disallowances, and other recoveries of payments made under
HHS programs, of HHS components operating in their regions.
The HHS regional offices are located in the following cities and
cover all states and territories of the United States, as well as three
independent states in the Pacific.
1. OGC Region 1--Philadelphia.
2. OGC Region 2--Atlanta.
3. OGC Region 3--Kansas City (MO).
4. OGC Region 4--Denver.
Robert F. Kennedy, Jr.,
Secretary, U.S. Health and Human Services.
[FR Doc. 2025-04130 Filed 3-13-25; 8:45 am]
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