Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices 6349 

response for bureau programs; and (8) 

coordinates bureau/quality 

improvement and performance 

reporting activities within HRSA and 

HHS, and with other federal agencies, 

state and local governments, and other 

public and private organizations 

concerned with primary health care, 

eliminating health disparities, and 

improving the health status of the 

nation’s underserved and vulnerable 

populations. 

Chapter RM—Maternal and Child 

Health Bureau 

Section RM.20 Function 

Delete the functional statement for the 

Division of Child, Adolescent and 

Family Health (RM3) and replace with 

the following: 

Division of Child, Adolescent and 

Family Health (RM3) 

The Division of Child, Adolescent and 

Family Health provides national 

leadership in planning, directing, 

coordinating, monitoring, and 

evaluating national programs focusing 

on the promotion of health and 

prevention of disease and injury among 

children, adolescents, young adults and 

their families with special emphasis on 

the development and implementation of 

family-centered, comprehensive, 

coordinated, community-based, and 

culturally competent systems of care for 

such populations. Specifically, the 

Division: (1) Administers a program 

which supports the development of 

systems of care and services for 

children, adolescents, young adults, and 

their families; (2) develops policies and 

guidelines and promulgates standards 

for professional services and effective 

organization and administration of 

health programs for children, 

adolescents, young adults, and their 

families; (3) accounts for the 

administration of funds and other 

resources for grants, contracts, and 

programmatic consultation and 

assistance; (4) coordinates with the 

Maternal and Child Health Bureau 

Divisions and Offices in promoting 

program objectives and the mission of 

the bureau; (5) serves as the focal point 

within the bureau in implementing 

programmatic statutory requirements for 

state programs for children, adolescents, 

young adults, and their families; (6) 

provides consultation and technical 

assistance to state programs for 

children, adolescents, young adults, and 

their families and to local communities, 

consistent with a bureau-wide technical 

assistance consultation plan, working 

with other agencies and organizations; 

(7) provides liaison with public, private, 

professional and voluntary 

organizations on programs designed to 

improve services for children, 

adolescents, young adults, and their 

families; (8) carries out a national 

program supporting Child Death Review 

systems; (9) carries out a national 

program on school health activities; (10) 

carries out a national program designed 

to improve the provision of emergency 

medical services for children; (11) 

administers the Poison Control Program; 

(12) carries out a national program 

designed to improve the provision of 

oral health services for children; (13) 

carries out a national program on injury 

prevention for children and adolescents; 

(14) coordinates within this agency and 

with other federal programs 

(particularly Title XIX of the Social 

Security Act) to extend and improve 

comprehensive, coordinated services 

and promote integrated state-based 

systems of care for children, 

adolescents, young adults, and their 

families; (15) disseminates information 

on preventive health services and 

advances in the care and treatment of 

children, adolescents, young adults, and 

their families; (16) participates in the 

development of strategic plans, 

regulatory activities, policy papers, 

legislative proposals, and budget 

submissions relating to health services 

for children, adolescents, young adults, 

and their families; and (17) administers 

funds and other resources for grants, 

contracts, and cooperative agreements. 

Chapter RR—Healthcare Systems 

Bureau 

Section RR.10 Organization 

Delete the organization for the 

Healthcare Systems Bureau (RR) in its 

entirety. 

Section R.30, Delegation of Authority 

All delegations of authority and redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegation, if allowed, 

provided they are consistent with this 

reorganization. 

This reorganization is effective upon 

date of signature. 

Authority: 44 U.S.C. 3101 

Dated: January 14, 2021. 

Alex M Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–01227 Filed 1–15–21; 4:15 pm] 

BILLING CODE 4165–15–P 

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 InterAgency 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 


jbell on DSKJLSW7X2PROD with NOTICES
6350 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices 

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 noncareer 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 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices 6351 

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 


jbell on DSKJLSW7X2PROD with NOTICES
6352 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices 

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 Departmentwide 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, noncareer 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 postemployment 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. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices 6353 

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 § 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 ediscovery 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 


jbell on DSKJLSW7X2PROD with NOTICES
6354 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Office of the Assistant Secretary for 

Financial Resources; Statement of 

Organization, Functions, and 

Delegations of Authority 

SUMMARY: The Department of Health and 

Human Services (HHS) is updating and 

realigning a portion of two offices 

within the Office of the Assistant 

Secretary for Financial Resources 

(ASFR), Office of the Secretary: the 

Immediate Office (AM) and the Office of 

Finance (AMS) ASFR is modifying its 

structure to move the Division of 

Enterprise Risk Management from the 

Office of Finance to the Immediate 

Office and establish the Division of 

Administrative Operations and Grants 

Quality Service Management Office 

within the Immediate Office (AM). 

FOR FURTHER INFORMATION CONTACT: 

Christine Jones, Deputy Assistant 

Secretary Operations and Management, 

ASFR, 200 Independence Ave, SW, 

Washington, DC 20201, (202) 690–6061. 

SUPPLEMENTARY INFORMATION: Part A 

(Office of the Secretary), Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (HHS) is being amended at 

Chapter AM, Office of Financial 

Resources, as last amended at 76 FR 

69741–42, dated November 9, 2011, and 

74 FR 57679–82, dated November 9, 

2009. This reorganization modifies 

ASFR’s structure to elevate key 

Department and Government-wide 

functions and improve operational 

functionality by creating the Division of 

Administrative Operations and the 

Grants Quality Services Management 

Office (QSMO) within the Immediate 

Office of the Assistant Secretary and 

realigning the Division of Enterprise 

Risk Management (ERM) from the Office 

of Finance to the Immediate Office of 

the Assistant Secretary for Financial 

Resources This reorganization will make 

the following changes under Chapter 

AM, Office of Financial Resources: 

I. Under Section AM.10 Organization, 

insert the following: 

A. Immediate Office of the Assistant 

Secretary (AM). The Immediate Office 

(IO) is headed by the Deputy Assistant 

Secretary for Operations and 

Management and includes the: 

Æ Division of Administrative 

Operations 

Æ Grants QSMO Office 

Æ Division of Enterprise Risk 

Management 

II. Under Section AM.20 Functions, 

insert the following sections: 

A. Immediate Office of the Assistant 

Secretary (AM). The Immediate Office 

(IO) is responsible for support, 

operations, and coordination required to 

execute the mission of ASFR including 

implementation of HHS’s Enterprise 

Risk Management (ERM) program and 

oversight of the Grants QSMO Office. 

(1) Division of Administrative 

Operations. The Division: 

(a) Provides operational support for 

the ASFR; 

(b) Coordinates administrative and 

operational issues across ASFR. 

(c) Leads strategic planning for ASFR; 

(d) Serves as the liaison with internal 

and external stakeholders regarding 

operational matters; 

(e) Leads ASFR workforce 

development initiatives; and 

(f) Leads other activities that enhance 

ASFR’s management and operations 

(2) Division of Enterprise Risk 

Management. The Division: 

(a) Coordinates across HHS to 

establish, and communicate, and sustain 

HHS’s ERM vision, culture, strategy, 

and framework; 

(b) Designs, implements, and matures 

an ERM capability across HHS, 

including governance and community 

management; 

(c) Develops and shares tools, 

guidance, and best practices regarding 

ERM; 

(d) Provides technical assistance and 

direction to HHS Operating Divisions 

(OPDIVs) and Staff Divisions 

(STAFFDIVs) on implementing ERM; 

(e) Facilitates strategic initiatives 

across HHS’s risk portfolio including 

guiding updates of the agency’s risk 

profile, and management’s prioritization 

of risks and opportunities; 

(f) Leads the Department’s efforts to 

meet the ERM requirement in OMB 

Circular A–123, ‘‘Management’s 

Responsibility for Enterprise Risk 

Management and Internal Control’’; 

(g) Prepares reports, briefings, and 

makes recommendations to senior HHS 

leadership, OPDIVs, STAFFDIVs and 

other stakeholders on ERM related 

activities; and 

(h) Leads activities that enhance HHS 

implementation and integration of ERM 

into business operations. 

(3) The Grants Quality Service 

Management Office (Grants QSMO). The 

Office: 

(a) Offers and manages a marketplace 

of solutions for common technology, 

services, or fully managed services to 

respond to agency needs; 

(b) Guides and governs the long-term 

sustainability of the services and 

solutions; 

(c) Works with agencies on alternative 

strategies to help them build a business 

case if a marketplace for a particular 

solution is not yet available; 

(d) Administers a customer 

engagement and feedback model that 

allows for continuous improvement and 

performance management of solutions; 

(e) Drives the implementation of 

standards that produce efficiencies in 

process and scale and that are 

established through the collaborative 

governance process; and 

(f) Analyzes the status of the 

government-wide grants management 

ecosystem and present information and 

recommendations to HHS executives 

and other inter-government stakeholders 

to inform strategic decisions on federal 

investments in technology and services 

for grants management. 

III. Under D Chapter AMS, Office of 

Finance (AMS) section AMS.00 

Mission: 

A. Replace Section 1. Immediate 

Office (AMS) with: 

1. Immediate Office (AMS). The 

Immediate Office (IO) is responsible for 

support and coordination to execute the 

mission of OF: 

(1) Provides leadership for the HHS 

CFO community; 

(2) Leads strategic planning for the 

HHS CFO community and the Office of 

Finance; 


jbell on DSKJLSW7X2PROD with NOTICES