[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Pages 6349-6354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Statement of Organization, Functions, and Delegations of 
Authority

January 7, 2021.
AGENCY: Office of the General Counsel, Office of the Secretary, HHS.

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), to reflect, among other things, OGC participation in the Inter-
Agency False Claims Act Working Group and re-allocation of 
responsibilities concerning certain requests under the Freedom of 
Information Act. Issuance of this Statement of Organization rescinds 
all prior Statements of Organization.

SUPPLEMENTARY INFORMATION: The Office of the Secretary (OS)'s 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 Mission of the Office of the General 
Counsel and the General Counsel, who is the special advisor to the 
Secretary on legal matters, is to provide all legal services and advice 
to the Secretary, Deputy Secretary, and all subordinate organizational 
components of the Department.
    Section II. Organization. The Office of the General Counsel, under 
the supervision of a General Counsel, consists of:
1. The General Counsel and Immediate Office of the General Counsel
2. Divisions in the Office of the General Counsel
3. Ten 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 shall consist of the General Counsel, his 
or her executive assistant, a Principal Deputy General Counsel, such 
other Deputy General Counsel, both non-career and career, as the 
Secretary deems appropriate and appoints, Associate and Assistant 
Deputy General Counsel, Senior Counsel, and such other attorneys and 
assistants 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

[[Page 6350]]

Department and is directly responsible to the Secretary.
    b. Principal Deputy General Counsel. The Principal Deputy General 
Counsel shall be the second-ranking legal officer of the Department and 
is directly responsible to the General Counsel and the Secretary. He or 
she may act in the stead of the General Counsel when the General 
Counsel is absent or unavailable.
    c. Deputy General Counsel. The Deputy General Counsel report to the 
General Counsel and each shall be responsible for overseeing such 
substantive areas as designated by the General Counsel. In certain 
instances, a Deputy General Counsel may be appointed by the Secretary 
or assigned by the General Counsel to serve as the chief counsel of an 
operating division.
    (1) Non-Career Deputy General Counsel. Non-career Deputy General 
Counsel report to the General Counsel and each shall be responsible for 
overseeing the substantive legal areas and corresponding OGC components 
designated by the General Counsel.
    (2) Career Deputy General Counsel. There shall be two career Deputy 
General Counsel who report to the General Counsel. First, a Deputy 
General Counsel who shall oversee OLR, the General Law Division (GLD), 
the ten Regional Offices, and will be generally responsible for OGC 
management and operations subject to the direction of the General 
Counsel. Second, a Deputy General Counsel who shall oversee litigation 
and the National Complex Litigation and Investigations Division 
(NCLID).
    d. Associate General Counsel. Associate General Counsel either head 
a Division within OGC or are located in the Immediate Office. In either 
event, Associate General Counsel report to the General Counsel or to 
such Deputy General Counsel as the General Counsel may designate.
    e. Associate or Assistant Deputy General Counsel to the General 
Counsel. The General Counsel may designate one or more attorneys to act 
as his or her special assistant and to carry the title of Associate 
Deputy General Counsel or Assistant Deputy General Counsel, all of whom 
shall report directly to the General Counsel or to such Deputy General 
Counsel as the General Counsel may designate.
    f. Senior Counsel or Senior Advisor to the General Counsel. Senior 
Counsel or Senior Advisor to the General Counsel perform such duties as 
may be assigned to them by the General Counsel, Deputy General Counsel, 
or Associate General Counsel. At least one Senior Counsel or Senior 
Advisor should have a security clearance of the level and type deemed 
appropriate by the General Counsel.
    g. Office of Legal Resources. The Office of Legal Resources within 
the Immediate Office of the General Counsel, headed by a director, is 
responsible for providing personnel, budget, correspondence, and 
information technology support to the Office of the General Counsel.
    2. Relation of Immediate Office to the Divisions and Regions. Each 
division and each region is under the general supervision of the 
General Counsel and the assigned Deputy General Counsel, unless that 
Division is headed by a Deputy General Counsel. Each Divisional 
Associate General Counsel and Regional Chief Counsel reports directly 
to the assigned Deputy General Counsel on substantive legal matters, 
litigation strategy, and other matters as directed by the General 
Counsel.
    3. 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 non-career 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. In the event that the disabilities or 
vacancies extend to or include all non-career deputies, then the career 
Deputy General Counsel with the greatest seniority in that position 
shall act in or serve as the Acting General Counsel as dictated by the 
Vacancies Reform Act of 1998.

Subsection B. Divisions in the Office of the General Counsel

    The Office of the General Counsel's nine divisions are as follows: 
General Law Division (GLD); the Children, Families and Aging Division 
(CFAD); the Ethics Division (ETHICSD); the Food and Drug Division 
(FDD); the Public Health Division (Ph.D.); the Legislative Division 
(LEGD); the Centers for Medicare & Medicaid Services Division (CMSD); 
the Civil Rights Division (CRD); and National Complex Litigation and 
Investigations Division (NCLID). Each Division shall be headed by 
either an Associate General Counsel or Deputy General Counsel, as 
determined by the General Counsel.
    1. The General Law Division shall be headed by an Associate General 
Counsel who reports to the General Counsel through a career Deputy 
General Counsel. The Division consists of two branches, each headed by 
a Deputy Associate General Counsel reporting to the Associate General 
Counsel:

a. Claims and Employment Law Branch
b. Procurement, Fiscal, and Information Law Branch

    2. The Children, Families, and Aging Division shall be headed by an 
Associate General Counsel who reports to the General Counsel through a 
designated Deputy General Counsel.
    3. The Ethics Division shall be headed by an Associate General 
Counsel who reports to the 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 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.
    4. The Food and Drug Division shall be headed by a Chief Counsel 
who shall be either a Deputy General Counsel or Associate General 
Counsel. In the event that the Chief Counsel is an Associate General 
Counsel, he or she shall report to the General Counsel through a 
designated Deputy General Counsel. The Division consists of two major 
branches, each of which is headed by a Deputy Associate General Counsel 
who reports to the Chief Counsel, as follows:

a. Litigation Branch
b. Program Review Branch, divided into the following three sub-
branches:
    (1) Foods & Veterinary Medicine
    (2) Drugs and Biologics
    (3) Tobacco & Devices

    5. The Public Health Division shall be headed by an Associate 
General Counsel who reports to the General Counsel through a designated 
Deputy General Counsel. The Division is divided into four branches, 
each of which is headed by a Deputy Associate General Counsel reporting 
to the Associate General Counsel:

a. Indian Health Service Branch
b. Centers for Disease Control and Prevention Branch

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c. National Institutes of Health Branch
d. Public Health and Science Branch

    6. The Legislation Division shall be headed by an Associate General 
Counsel who reports to the General Counsel through a designated Deputy 
General Counsel.
    7. The Centers for Medicare & Medicaid Services Division shall be 
headed by a Chief Legal Officer who shall be either a Deputy General 
Counsel or an Associate General Counsel. The Division consists of three 
major organizational groups, each of which is headed by a Deputy 
Associate General Counsel reporting to the Associate General Counsel or 
the Deputy General Counsel through an Associate General Counsel, as 
follows:

a. Litigation Group
b. Program Review Group
c. Program Integrity Group

    8. The Civil Rights Division shall be headed by an Associate 
General Counsel who reports to the General Counsel through a designated 
Deputy General Counsel, and by a Deputy Associate General Counsel who 
reports to the Associate General Counsel.
    9. The National Complex Litigation and Investigations Division 
(NCLID) has an Associate General Counsel who reports to General Counsel 
through a career Deputy General Counsel. In addition, NCLID has a 
Deputy Associate General Counsel for E-Discovery who reports to the 
Associate General Counsel.

Subsection C. Regional Offices

    There are ten regional offices. Each regional office has a Chief 
Counsel who reports to the General Counsel through a designated career 
Deputy General Counsel. Regional offices may also have one or more 
Deputy Chief Counsel who report to the Chief Counsel. The regional 
offices are located in the following cities and provide legal services 
to the Department in the following states and territories:

1. Region I--Boston (Connecticut, Maine, Massachusetts, New Hampshire, 
Rhode Island, Vermont)
2. Region II--New York City (New York, New Jersey, Puerto Rico, Virgin 
Islands)
3. Region III--Philadelphia (Delaware, Maryland, Pennsylvania, 
Virginia, West Virginia, District of Columbia)
4. Region IV--Atlanta (Alabama, Florida, Georgia, Kentucky, 
Mississippi, North Carolina, South Carolina, Tennessee)
5. Region V--Chicago (Illinois, Indiana, Ohio, Michigan, Minnesota, 
Wisconsin)
6. Region VI--Dallas (Arkansas, Louisiana, New Mexico, Oklahoma, Texas)
7. Region VII--Kansas City, MO (Iowa, Kansas, Missouri, Nebraska)
8. Region VIII--Denver (Colorado, Montana, North Dakota, South Dakota, 
Utah, Wyoming)
9. Region IX--San Francisco (Arizona, California, Hawaii, Nevada, Guam, 
American Samoa, Commonwealth of the Northern Mariana Islands, the 
Federated States of Micronesia, the Republic of the Marshall Islands, 
the Republic of Palau)
10. Region X--Seattle (Alaska, Idaho, Oregon, Washington)

Section III. Functions

A. General Counsel and Immediate 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, or units of the Department in 
connection with the operations and administration of the Department and 
its programs, except with respect to functions expressly delegated by 
statute to the Inspector General.
    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, making and 
supervising all contacts with attorneys responsible for the conduct of 
such litigation.
    d. Acts as the Department's sole representative in communicating 
with the Department of Justice, including all United States Attorneys, 
on all civil matters and on all criminal matters, other than those 
criminal matters referred to the Department of Justice by the Inspector 
General.
    e. Acts as the Department's sole representative in communicating 
with Office of White House Counsel or the Offices of General Counsel 
for any other Department or Agency.
    f. Performs all liaison functions in connection with legal matters 
involving the Department, and formulating or reviewing requests for 
formal opinions or rulings by the Attorney General and the Comptroller 
General.
    g. Issues pre-enforcement rulings or advisory opinions to the 
public on questions of law, except to the extent that that such 
authority has previously been delegated to the Inspector General under 
section 1128D of the Social Security Act.
    h. Authorizes indemnification, as appropriate, pursuant to 45 CFR 
pt. 36.
    i. Conducts internal investigations at the request of the Secretary 
or Deputy Secretary, or for matters that could lead to litigation.
    j. Drafts all proposals for legislation originating in the 
Department and reviewing all proposed legislation submitted to the 
Department or to any operating agency of the Department for comment; 
preparing reports and letters to congressional committees, the Office 
of Management and Budget, and others on proposed legislation; and 
prescribing procedures to govern the routing and review, within the 
Department, of material relating to proposed Federal legislation.
    k. Performs liaison functions with the Office of the Federal 
Register, National Archives and Records Service.
    l. Reviews and approves all administrative complaints and 
enforcement actions by any agency within the Department before those 
complaints are filed or transmitted, or enforcement actions instituted 
to ensure that the complaint or enforcement action is legally sound.
    m. Leads all negotiations on behalf of any agency within the 
Department.
    n. Supervises all legal activities of the Department and its 
operating agencies.
    o. Ensures that no one in the Department, other than those in OGC 
or expressly authorized by statute to do so, provides any legal advice 
to anyone in the Department or uses any title that implies that they 
are functioning as a departmental lawyer.
    2. Principal Deputy General Counsel. The Principal Deputy General 
Counsel is the second ranking legal officer in the Department and 
performs the functions of the General Counsel in his or her absence or 
disability, including recusal, and, unless otherwise noted, oversees 
for the General Counsel all litigation involving the Department, its 
officers, inferior officers, and employees.
    3. Deputy General Counsel. The Deputy General Counsel assist the 
General Counsel in carrying out his or her responsibilities and 
performs such duties as the General Counsel or

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Principal Deputy General Counsel may assign. The Associate General 
Counsel for a Division shall report to the General Counsel through one 
or more Deputy General Counsel, as may be assigned by the General 
Counsel. Regional Chief Counsel shall report to the General Counsel 
through a career Deputy General Counsel.

B. Functions, Authorities and Responsibilities of the Division

    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 assigned Deputy General Counsel.
    1. General Law Division. The General Law Division, acting through 
its Associate General Counsel, performs the following:
    a. Provides legal services on business management activities and 
administrative operations throughout the Department, including 
employment, compensation, personnel, appropriations, real and personal 
property (including National Environmental Policy Act), procurement, 
information, travel, and certain claims by and against the Department.
    b. Represents the Department in all aspects of administrative 
litigation before the Merit Systems Protection Board (MSPB), Equal 
Employment Opportunity Commission (EEOC), and in labor arbitrations, as 
needed. Acts as agency counsel in support of the Department of Justice 
on employment cases filed in federal court.
    c. Represents the Department in bid protests filed before the 
Comptroller General and contract disputes filed before the Civilian 
Board of Contract Appeals. Acts as agency counsel in support of the 
Department of Justice in bid protests and contract disputes filed 
before the U.S. Court of Federal Claims and appealed to the Federal 
Circuit.
    d. Except as noted, provides legal services to Department Freedom 
of Information Act (FOIA) Officers on the disclosure of agency records 
requested under FOIA, and communicates with the Department of Justice 
on the administration of the Freedom of Information Act.
    e. Provides legal services to the Department on the Privacy Act of 
1974, as amended, the Paperwork Reduction Act, the Federal Records Act, 
and the Government in the Sunshine Act.
    f. Provides all legal services with respect to the formation, 
maintenance, and administration of the advisory committees under the 
Federal Advisory Committee Act.
    g. Acts as the Department Claims Officer, responsible for 
adjudicating all administrative claims filed under the Federal Tort 
Claims Act, approval of claims filed under the Federal Medicare 
Recovery Claims Act in amounts of at least $20,000 but not exceeding 
$300,000, tort liability claims under the U.S. Constitution and other 
laws under which claims for money damages may be filed with the 
Department, as provided by 5 U.S.C. 5584, 10 U.S.C. 2774, except for 
claims arising under the Social Security Act. Also responsible for 
making final determinations on legally enforceable non tax debts owed 
to the United States government arising from HHS programs under the 
Federal Claims Collection Act, as amended, 31 U.S.C. 3711 et seq., on 
the compromise of, and the suspension or termination of collection 
activities for, claims in amounts of $100,000 or less, exclusive of 
interest, and on the waiver of interest.
    2. Children, Families, and Aging Division. The Children, Families, 
and Aging Division 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.
    3. Ethics Division. The Ethics Division 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. The Division, without limitation, performs the following:
    a. Provides legal advice and policy guidance on interpretation and 
compliance issues involving the criminal conflict of interest statutes, 
18 U.S.C. 210-219, political activity restrictions, anti-lobbying 
provisions, outside activity limitations, travel reimbursement 
guidelines, procurement integrity rules, financial disclosure 
obligations, and standards of ethical conduct matters including gifts 
between employees and from outside sources, conflicting financial 
interests and impartiality concerns, misuse of position and agency 
resources, and outside employment, fundraising, testimony, and 
teaching, speaking or writing, to Department officials, agency 
personnel, advisory committees and others.
    b. Reviews executive branch public financial disclosure reports 
submitted by Presidential nominees/appointees subject to Senate 
confirmation, non-career SES and Schedule C political appointees, OGC 
career SES officials, and Op/Staff Division ethics officials (DECs) to 
assess potential violations of applicable laws or regulations, ensure 
transparency through accurate reporting, provide counseling on the 
avoidance of conflicts, and, if necessary, recommending appropriate 
corrective action, including drafting waivers, disqualification 
statements, ethics agreements, and certificate of divestiture 
materials; ensuring identical review and counseling responsibilities 
with respect to both the public and confidential financial disclosure 
forms filed by career employees are performed Department-wide by the 
DECs.
    c. Plans, develops, and provides initial ethics orientation for new 
employees, annual ethics training for employees who file financial 
disclosure forms and others occupying certain sensitive positions, 
initial and annual ethics training for members of federal advisory 
committees, and specialized, topic-specific training on post-employment 
restrictions, political activity restrictions, insider trading, and 
procurement integrity rules.
    d. Monitors component ethics programs and reviewing compliance with 
core ethics program elements, including advice, financial disclosure, 
outside activities, conflict of interest waivers, ethics agreements and 
travel payments from non-federal sources.
    e. 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 the Inspector General, 
Special Investigations Unit, the Office of Personnel Management, and 
the General Services Administration.
    f. Develops component-specific conduct regulations and implementing 
procedures.
    4. Food and Drug Division. The Food and Drug Division acts as the 
Commissioner's legal advisor and provides legal services to FDA. FDD, 
for example, performs the following:
    a. Represents the FDA in connection with judicial and 
administrative proceedings involving programs administered by the FDA. 
Provides legal advice and policy guidance for programs administered by 
the FDA.
    b. Acts as the Department and FDA's sole liaison to the Department 
of Justice and other Federal Departments for programs administered by 
FDA; all criminal prosecutions, investigations, and civil matters may 
only be referred to the Department of Justice through the Chief 
Counsel.
    c. Drafts or reviews all proposed and final regulations and Federal 
Register notices prepared by FDA.

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    d. Performs legal research and gives legal opinions on regulatory 
issues, actions, and petitions submitted to FDA.
    e. Reviews proposed legislation affecting FDA that originates in 
the Department or on which Congress requests the views of the 
Department.
    f. Provides legal advice and assistance to the Office of the 
Secretary on matters within the expertise of the Chief Counsel.
    5. Public Health Division. The Public Health Division provides 
legal services to all Public Health Service agencies (except to the 
Food and Drug Administration) and their programs, including the Office 
of the Surgeon General and the Commissioned Corps of the U.S. Public 
Health Service. Represented Public Health Service agencies include, but 
are not limited to the (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, and (ix) the 
Office of the Assistant Secretary for Preparedness and Response. In 
addition, the Public Health Service Division serves as the lead office 
within the Office of the General Counsel for grants-related and 
intellectual property issues, other than federal court or PTAB 
litigation.
    6. Legislation Division. The Legislation Division performs the 
following:
    a. Drafts all proposed legislation originating in the Department, 
reviewing specifications for such proposed legislation, and reviewing 
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.
    7. Centers for Medicare & Medicaid Services Division. The Centers 
for Medicare & Medicaid Services Division, acting through the Deputy 
General Counsel serving as the CMS Chief Legal Officer or an Associate 
General Counsel,
    a. Acts as the CMS Administrator's legal advisor.
    b. Represents CMS and the Office of the National Coordinator for 
Health Information Technology (``ONC'') in court proceedings and 
administrative hearings with respect to programs administered by CMS or 
ONC.
    c. Provides legal advice and policy guidance for programs 
administered by CMS and ONC.
    d. Acts as the Department's and CMS's and ONC's liaison to the 
Department of Justice and other Federal Departments for programs 
administered by those operating divisions.
    e. Drafts or reviews all proposed and final regulations and Federal 
Register notices prepared by CMS, ONC, and other agencies.
    f. Performs legal research and gives legal opinions on regulatory 
issues, actions, and petitions submitted to CMS and ONC.
    g. Reviews proposed legislation affecting CMS, ONC, Office of 
Medicare Hearing Appeals (OMHA) and DAB that originates in the 
Department or on which Congress requests the views of the Department.
    h. Provides legal advice and assistance to the Office of the 
Secretary on matters within the expertise of the CMS Chief Legal 
Officer.
    i. Provides legal advice and assistance to the Office of the 
Secretary on matters relating to the COVID-19 Provider Relief Fund 
(PRF) and similar provider relief programs, including advice regarding 
the administration of the PRF, civil litigation relating to the PRF, 
and fraud and abuse involving PRF payments.
    8. Civil Rights Division. The Civil Rights Division provides legal 
services for the Office for Civil Rights (OCR) and provides advice with 
respect to the civil rights laws to all agencies and offices within the 
Department. Among other things, CRD evaluates complaints, determines 
whether there is legal basis to proceed (which determination is binding 
on OCR), assists OCR in developing and implementing investigation 
plans, and clears the imposition of any civil money penalties. CRD 
likewise represents the Department in administrative proceedings and 
federal litigation, together with the Department of Justice. CRD 
provides these legal services with respect to:
    a. Traditional civil rights laws such as, by way of example, title 
VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.), title IX 
of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.), the Age 
Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), section 504 of the 
Rehabilitation Act of 1973 (29 U.S.C. 794), the Americans with 
Disabilities Act of 1990 (42 U.S.C. 12101 et seq. and 47 U.S.C. 225, 
661), section 1557 of the Affordable Care Act (42 U.S.C. 18116).
    b. Conscience statutes, such as the Church Amendments, the Weldon 
Amendment, and the Coats-Snowe Amendment.
    c. 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.
    9. National Complex Litigation and Investigations Division. The 
National Complex Litigation and Investigations Division provides legal 
services across the Department, as directed by the General Counsel or 
Principal Deputy General Counsel. In that regard, NCLID, performs the 
following:
    a. Coordinates litigation spanning multiple OGC divisions, regional 
offices, or geographic areas.
    b. Reviews all FOIA requests for documents generated by the 
Secretary or Acting Secretary, or the Chief of Staff, current or 
former, to either. All productions of documents from the Secretary, 
Acting Secretary, or Chief of Staff, current or former, must be 
approved by a career Deputy General Counsel or his or her designee.
    c. Serves as the General Counsel's representative(s) to the Inter-
Agency False Claims Act Working Group.
    d. 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 OGC 
regions request NCLID participation; cases spanning multiple OGC 
divisions or regional offices, or cases outside the scope of other OGC 
divisions or regional offices.
    e. Conducts internal investigations at the request of the Secretary 
or Deputy Secretary, or on matters that could lead to litigation or 
warrant prompt review.
    f. Administers the OGC-wide e-discovery program, and coordinates 
the use of e-discovery technology with other HHS staff and operating 
divisions.
    g. Identifies and supports the implementation of best practices for 
litigation management, e-discovery, and virtual staffing across OGC.

C. Functions, Authorities and Responsibilities of the Regions

    The Chief Counsel of each Region is HHS' legal representative in 
that Region. Regional offices within OGC provide a

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full range of legal services including, by way of example, legal 
counsel to their departmental clients and client agencies in the 
regions, as described below, subject to the professional supervision 
and direction of the General Counsel.
    The Office of the General Counsel's ten regional offices provide 
legal advice, administrative and judicial litigation support and 
counseling services to the regional components of the Department. 
Regional attorneys provide general law support to regional clients and 
handle work in most areas within HHS' jurisdiction with particular 
emphasis on litigation for, among others, CMS, ACF, OCR, CDC, and IHS. 
Regional offices also provide leadership with respect to bankruptcy 
cases. In the area of civil rights, they work in close consultation 
with the Associate General Counsel for the Civil Rights Division to 
ensure that the regional positions align closely with those of the 
Division thereby fostering national uniformity. In other areas, the 
Divisions and Regions work collaboratively to provide consistent, 
uniform legal advice.

    Dated: January 11, 2021.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-00883 Filed 1-19-21; 8:45 am]
BILLING CODE P