6344 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices 

SUPPLEMENTARY INFORMATION: On 

September 24, 2020, the Department 

issued two requests for proposals for the 

reimportation of insulin and the 

personal importation of prescription 

drugs on its website. The proposals 

were issued consistent with FDA’s 

authorities under sections 801 and 804 

of the Food, Drug, and Cosmetic Act, 21 

U.S.C. 381, 384. The Department is 

issuing this Notice to include revised 

versions of these proposals in the 

Federal Register. 

Dated: January 13, 2021. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–01125 Filed 1–19–21; 8:45 am] 

BILLING CODE 4150–26–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

Part R (Health Resources and Services 

Administration) of the Statement of 

Organization, Functions and 

Delegations of Authority of the 

Department of Health and Human 

Services) (60 FR 56605, as amended 

November 6, 1995; as last amended at 

85 FR 34210–34212 dated June 3, 2020) 

is amended to reorganize sections of the 

Office of the Administrator, the Federal 

Office of Rural Health Policy, the 

Healthcare Systems Bureau, the 

Maternal and Child Health Bureau, and 

the Bureau of Primary Health Care. 

Key functional changes include 

establishing the Office of Special Health 

Initiatives, the Office of Provider 

Support, and the Office for the 

Advancement of Telehealth within the 

Office of the Administrator; abolishing 

the Healthcare Systems Bureau; and 

renaming two Offices within the Bureau 

of Primary Health Care to increase 

attention and focus on Health Center 

Program compliance and funding 

oversight. 

This reorganization establishes, 

updates, realigns, and/or deletes the 

organization, functions, and delegation 

of authority for the (1) Office of the 

Administrator (RA); (2) Office of Special 

Health Initiatives (RA4); (3) Office for 

the Advancement of Telehealth (RA3); 

(4) Federal Office of Rural Health Policy 

(RH); (5) Office of Provider Support 

(RD); (6) Healthcare Systems Bureau 

(RR); (7) Bureau of Primary Health Care 

(RC); and (8) Maternal and Child Health 

Bureau (RM). 

Chapter RA—Office of the 

Administrator 

Section RA.10 Organization 

Delete the organization for the Office 

of the Administrator (RA) in its entirety 

and replace with the following: 

(1) Immediate Office of the 

Administrator (RA); 

(2) Office of Communications (RA6); 

(3) Office of Legislation (RAE); 

(4) Office of Planning, Analysis and 

Evaluation (RA5); 

• Office of Policy Analysis (RA53); 

• Office of Research and Evaluation 

(RA56); 

• Office of External Engagement 

(RA57); 

• Office of Performance and Quality 

Measurement (RA58); 

• Office of Strategic Initiatives 

(RA59); 

(5) Office of Civil Rights, Diversity 

and Inclusion (RA2); 

(6) Office for the Advancement of 

Telehealth (RA3); 

(7) Office of Special Health Initiatives 

(RA4); 

• Office of Pharmacy Affairs (RA41); 

• Office of Global Health (RA42); 

Æ Division of Global Health (RA421); 

and 

• Division of Injury Compensation 

Programs (RA43). 

(8) Office of Health Equity (RAB); and 

(9) Office of Women’s Health (RAW). 

Section RA.20 Function 

Delete the functional statement for 

Immediate Office of the Administrator 

(RA) and replace; delete the functional 

statements for the Office of Global 

Health (RAI), and replace with the 

Office of Special Health Initiatives 

(RA4); and add the functional statement 

for the Office for the Advancement of 

Telehealth (RA3). 

Immediate Office of the Administrator 

(RA) 

The Immediate Office of the 

Administrator for the Health Resources 

and Services Administration (HRSA) 

leads and directs programs and 

activities of the agency and advises the 

Office of the Secretary of Health and 

Human Services on policy matters 

concerning them. Specifically, the 

Immediate Office of the Administrator: 

(1) Provides consultation and assistance 

to senior agency officials and others on 

clinical, health care delivery, and health 

workforce issues; (2) serves as the 

agency’s focal point on efforts to 

strengthen the practice of public health 

as it pertains to the HRSA mission; (3) 

establishes and maintains 

communication with health 

organizations in the public and private 

sectors; (4) coordinates the agency’s 

policy development, data strategy, 

evaluation and research planning 

processes; (5) manages the legislative 

analysis and engagement for the agency; 

(6) administers HRSA’s equal 

opportunity and civil rights activities; 

(7) provides overall leadership, 

direction, coordination and planning in 

support of the agency’s special health 

initiatives; (8) manages programs to 

advance the use of telehealth and 

coordination of health information 

technology; (9) manages HRSA’s global 

health issues; (10) leads HRSA’s efforts 

to improve the health, wellness, and 

safety of women and girls through 

policy, programming and outreach/ 

education; (11) provides leadership and 

policy development in the 

administration of the 340B Drug Pricing 

Program; (12) oversees efforts to address 

the special needs of minority and 

disadvantaged populations, including 

coordination of tribal activities for 

HRSA; (13) provides cross-cutting 

leadership on HRSA’s behavioral health 

and oral health programs; and (14) 

administers the National Vaccine Injury 

Compensation Program. 

Office for the Advancement of 

Telehealth (RA3) 

The Office for the Advancement of 

Telehealth (1) ensures successful 

dissemination of appropriate 

information technology advances, such 

as telehealth or electronic health records 

systems; (2) monitors the health 

information technology policy and 

activities of other HHS components for 

useful application in rural areas; (3) 

provides overall direction and 

leadership over the management of 

programs to advance the use of 

telehealth and coordination of health 

information technology; and (4) serves 

as the operational focal point for 

coordinating and advancing the use of 

telehealth technologies across all of 

HRSA’s programs including, but not 

limited to, the provision of health care 

at a distance (telemedicine), distance 

based learning to improve the 

knowledge of agency grantees and 

others, and improved information 

dissemination to both consumers and 

providers about the latest developments 

in telemedicine. 

The Office for the Advancement of 

Telehealth carries out the following 

functions: (1) Develops and coordinates 

telehealth network and telehealth 

resource centers grant programs; (2) 

provides professional assistance and 

support in developing telehealth 

initiatives; and (3) administers grant 

programs to promulgate and evaluate 

the use of appropriate telehealth 


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technologies among HRSA grantees and 

others. 

Office of Special Health Initiatives 

(RA4) 

Office of the Director (RA4) 

The Office of Special Health 

Initiatives (OSHI) provides a 

crosscutting focal point for HRSA to 

deliver on population health and 

Secretarial priorities, especially those 

that may be more clinical in nature. 

Specifically, OSHI (1) coordinates and 

collaborates with components in the 

Department of Health and Human 

Services (HHS) that align with the work 

of OSHI; (2) serves as the principal 

advisor within HRSA on global health 

issues; (3) provides agency-wide 

leadership and policy development in 

the administration of the 340B Drug 

Pricing Program to promote access to 

clinically and cost effective pharmacy 

services to the country’s most 

vulnerable patient populations; (4) 

serves as the lead on behavioral health 

issues that span HRSA; (5) provides 

cross-cutting leadership on HRSA oral 

health programs; and (6) directs and 

administers the National Vaccine Injury 

Compensation Program. 

Office of Pharmacy Affairs (RA41) 

The Office of Pharmacy Affairs 

promotes access to clinical and cost 

effective pharmacy services to enable 

participating entities to stretch scarce 

federal resources in order to serve more 

patients, expand their services, or offer 

additional services. Specifically, the 

Office of Pharmacy Affairs: (1) Manages 

the 340B Drug Pricing Program 

involvement of pharmaceutical 

manufacturers that participate in the 

Medicaid program, through 

Pharmaceutical Pricing Agreements; (2) 

maintains a publicly accessible database 

of participating covered entities, sites, 

and contract pharmacies; (3) publishes 

guidelines/regulations to assist in the 

understanding and participation in the 

340B Program; (4) maintains a Prime 

Vendor Program to increase the value of 

the 340B Program; (5) provides 

technical assistance to Program 

stakeholders to support their 

appropriate and best use of the 340B 

Program; (6) fosters mutually productive 

relationships with federal and private 

sector partners; (7) provides a national 

platform for the coordination and 

development of leading practices for 

pharmacy services; (8) promotes 

comprehensive and efficient pharmacy 

management application and systems 

use to ensure safe and effective 

medication use; (9) manages quality 

improvement activities; and (10) 

promotes program integrity compliance 

and improvement activities. 

Office of Global Health (RA42) 

The Office of Global Health provides 

expertise and advises HRSA on global 

health issues. Specifically, the Office of 

Global Health: (1) Provides leadership, 

coordination, and advancement of 

global health programs relating to 

sustainable health systems for 

vulnerable and at-risk populations; (2) 

provides leadership within HRSA for 

the support of global health and 

coordinates policy development with 

the HHS Office of Global Affairs, other 

departmental agencies, bilateral/ 

multilateral organizations, and other 

international organizations and 

partners; (3) monitors HRSA’s border 

health activities and investments, in 

partnership with HRSA’s Office of 

Regional Operations, to promote 

collaboration and improve health care 

access to those living along the U.S. 

borders, such as the U.S.-Mexico border 

and the U.S. Affiliated Pacific Islands; 

(4) provides management and oversight 

of international programs aimed at 

improving quality and innovation in 

human resources for health, health 

workforce recruitment, education, 

retention, and applied research systems; 

(5) supports and conducts programs 

associated with the international 

migration and recruitment of health 

personnel, foreign, and immigrant 

health workers; (6) provides support for 

the agency’s international travel and the 

Department of State’s International 

Visitors Leadership Program; and (7) 

provides national leadership, including 

serving as the Deputy Principal 

representative and providing support to 

the HRSA Administrator, implements 

training, and systems strengthening 

functions of the Global HIV/AIDS 

Program as part of the President’s 

Emergency Plan for AIDS Relief 

(PEPFAR). 

Division of Global Programs (RA421) 

The Division of Global HIV/AIDS 

Program provides national leadership, 

implements training, and systems 

strengthening functions of the Global 

HIV/AIDS Program as part of PEPFAR. 

This includes strengthening health 

systems for delivery of prevention, care 

and treatment services for people with 

HIV/AIDS in PEPFAR-funded countries 

and providing management and 

oversight of international programs 

aimed at improving quality and 

innovation in health professions 

education and training. The Division 

shares lessons learned from both the 

domestic and Global HIV/AIDS 

Programs grant recipient community. 

The Division of Global HIV/AIDS 

Program provides leadership in 

improving care, treatment, and support 

services for people with HIV/AIDS 

outside of the United States and its 

territories. Specifically, the Division: (1) 

In coordination with the Department of 

State’s Office of the Global AIDS 

Coordinator, plans, develops, 

implements, evaluates, and coordinates 

the activities of the clinical assessment 

system strengthening; (2) provides 

guidance and expertise to funded 

programs; (3) develops funding 

opportunity announcements and 

program guidance documents; (4) 

conducts on-site program reviews and 

reviews of pertinent and required 

reports, and activities to assess 

compliance with program policies and 

country priorities; (5) in conjunction 

with other division, bureau, and agency 

entities, assists in the planning and 

implementation of priority HIV 

activities such as workgroups, meetings, 

and evaluation projects; (6) collaborates 

with other federal agencies and incountry partners in the implementation 

of the PEPFAR program, and (7) 

provides management and oversight of 

international programs aimed at 

improving quality and innovation in 

health professions education, retention, 

training, faculty development, and 

applied research systems. 

Division of Injury Compensation 

Programs (RA43) 

The Division of Injury Compensation 

Programs, on behalf of the Secretary of 

HHS, administers and implements all 

statutory and charter authorities related 

to the operations of the National 

Vaccine Injury Compensation Program, 

the Countermeasures Injury 

Compensation Program, and the HHS 

Medical Review Claims Panel by: (1) 

Evaluating claims for compensation 

filed under the National Vaccine Injury 

Compensation Program and the 

Countermeasures Injury Compensation 

Program through medical review and 

assessment of compensability for all 

complete claims; (2) processing awards 

for compensation made under the 

National Vaccine Injury Compensation 

Program and the Countermeasures 

Injury Compensation Program; (3) 

promulgating regulations to develop and 

revise Vaccine and Countermeasures 

Injury Tables; (4) providing professional 

and administrative support to the 

Advisory Commission on Childhood 

Vaccines (ACCV) and the Medical 

Claims Review Panel; (5) maintaining 

responsibility for activities related to the 

ACCV including the development of 

policy, regulations, budget formulation, 

and legislation; the development and 


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renewal of its charter and action 

memoranda to the Secretary; and the 

analysis of its findings and proposals; 

(6) developing and maintaining all 

automated information systems 

necessary for program implementation; 

(7) developing and disseminating 

program information; (8) maintaining a 

working relationship with the 

Department of Justice (DOJ) and the U.S. 

Court of Federal Claims through the 

DOJ, in the administration and 

operation of the National Vaccine Injury 

Compensation Program; (9) providing 

management, direction, budgetary 

oversight, coordination, and logistical 

support for the Medical Expert Panel, as 

well as Clinical Reviewer contracts; (10) 

developing, reviewing, and analyzing 

pending and new legislation relating to 

program changes, new initiatives, the 

ACCV, and changes to the Vaccine and 

Countermeasures Injury Tables, in 

coordination with the Office of the 

General Counsel; (11) providing 

programmatic outreach efforts to 

maximize public exposure to private 

and public constituencies; (12) 

providing submission of special reports 

to the Secretary of HHS, the Office of 

Management and Budget, Congress, and 

other governmental bodies; and (13) 

providing guidance in using the results 

and decisions of the Medical Claims 

Review Panel to HHS Operating 

Divisions to improve the quality of 

health care in its facilities and by its 

practitioners. 

Chapter RH—Federal Office of Rural 

Health Policy 

Section RH.10 Organization 

Delete the organization for the Federal 

Office of Rural Health Policy (RH) in its 

entirety and replace with the following: 

The Federal Office of Rural Health 

Policy (RH) is headed by the Associate 

Administrator, who reports directly to 

the Administrator, HRSA. The Federal 

Office of Rural Health Policy includes 

the following components: 

(1) Office of the Associate 

Administrator (RH); 

(2) Hospital State Division (RH1); 

(3) Community-Based Division (RH2); 

(4) Policy Research Division (RH5); 

(5) Administrative Operations 

Division (RH6); and 

(6) Rural Strategic Initiatives Division 

(RH7). 

Section RH.20 Function 

Delete the functional statement for the 

Office of the Associate Administrator 

and replace with the following: 

Federal Office of Rural Health Policy 

Office of the Associate Administrator 

(RH) 

The Federal Office of Rural Health 

Policy (FORHP) is responsible for the 

overall leadership and management of 

the Office. FORHP serves as a focal 

point within HHS for rural healthrelated issues and as a principal source 

of advice to the Secretary for 

coordinating efforts to strengthen and 

improve the delivery of health services 

to populations in the nation’s rural 

areas. FORHP provides leadership 

within HHS and with stakeholders in 

providing information and counsel 

related to access to, and financing and 

quality of, health care to rural 

populations. Specifically, the Office of 

the Associate Administrator (1) Provides 

staff support to the National Advisory 

Committee on Rural Health and Human 

Services; (2) stimulates and coordinates 

interaction on rural health activities and 

programs in the agency, Department and 

with other federal agencies; (3) directs 

and oversees the development and 

implementation of a research agenda 

that supports delivery of health services 

in rural areas; (4) provides overall 

direction and leadership over the 

management of nationwide communitybased rural health grants programs; (5) 

provides overall direction and 

leadership over the management of a 

program of state grants which supports 

collaboration within state offices of 

rural health; (6) provides overall 

direction and leadership over the 

Office’s administrative and management 

functions; and (7) provides overall 

direction and leadership over the 

Office’s new rural health program 

initiatives created as a result of agency, 

Department and/or administrative 

priorities. 

Chapter RD—Office of Provider Support 

Chapter RD.00 Mission 

The Office of Provider Support 

ensures resiliency of the nation’s health 

care systems and infrastructure by 

supporting health care entities in the 

U.S. to prevent, prepare for and respond 

to coronavirus disease 2019 (COVID– 

19). 

Section RD.10 Organization 

Establish the Office of Provider 

Support organization as follows: 

The Office of Provider Support (RD) is 

headed by the Associate Administrator, 

who reports directly to the 

Administrator, HRSA. The Office of 

Provider Support includes the following 

components: 

(1) Office of the Associate 

Administrator (RD); 

(2) Division of Provider Support 

(RD1); 

(3) Division of Customer Support 

(RD2); and 

(4) Division of Data Analytics and 

Program Integrity (RD3). 

Section RD. Function 

Establish the function of the Office of 

Provider Support (RD) as follows: 

Office of Provider Support (RD) 

The Office of Provider Support 

ensures resiliency of the nation’s health 

care systems and infrastructure by 

supporting health care entities in the 

U.S. to prevent, prepare for and respond 

to coronavirus. The Office reimburses 

health care providers for health care 

related expenses or lost revenues 

attributable to coronavirus and to 

provides claims reimbursement for 

health care entities for COVID–19 

testing and treatment for uninsured 

individuals. 

Office of the Associate Administrator 

(RD) 

The Office of the Associate 

Administrator provides overall 

leadership, direction, coordination, and 

planning in support of the programs 

designed to make payments to health 

care providers for expenses and lost 

revenue related to COVID–19 and to 

reimburse health care entities’ claims 

for COVID–19 testing and/or treatment 

of uninsured individuals, helping to 

ensure a sustained, robust health care 

system. The Office guides and directs 

the development of policy priorities for 

the allocation of payments and claims 

reimbursements and ensures the proper 

management of programs. Specifically, 

the Office of the Associate 

Administrator: (1) Provides overall 

direction and leadership over the 

management of funds to reimburse 

health care providers for expenses and 

lost revenue related to COVID–19; (2) 

provides overall direction and 

leadership over the management of 

funds dedicated specifically for the 

testing and treatment of the uninsured 

individuals with possible or actual cases 

of COVID–19; (3) directs data collection 

and analysis in support of program 

execution; (4) provides oversight of an 

audit protocol and plan that monitors 

proper execution of funds; (5) ensures 

compliance with regulations and limits 

risk through establishment and 

maintenance of a system of internal 

controls; (6) maintains effective 

relationships within HRSA and with 

other federal and nonfederal agencies, 

state, and local governments, and other 

public and private organizations 

associated with the response to COVID– 


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19; (7) plans, directs, coordinates, and 

evaluates the Office’s administrative 

and management functions, e.g., budget, 

personnel, procurements, delegations of 

authority, and responsibilities related to 

the awarding of program funds; (8) 

represents the Office, agency, and 

federal government, as designated, with 

other federal and non-federal agencies, 

state and local governments, and other 

public and private organizations 

concerned with the response to COVID– 

19 and the resiliency of the national 

healthcare systems; and (9) coordinates, 

reviews, and provides clearance of 

correspondence and official documents 

entering and leaving the Office. 

Division of Policy and Program 

Operations (RD1) 

The Division of Policy and Program 

Operations is the focal point for the 

policy development, program 

operations, and communications 

operations for Office programs. 

Specifically, the Division of Policy and 

Program Operations: (1) Works with the 

contractor to ensure effective and 

efficient program operations; (2) leads 

and coordinates the analysis, 

development, and drafting of policies 

impacting Office programs; (3) analyzes 

issues arising from legislation, budget 

proposals, regulatory actions and other 

program or policy actions; (4) works 

collaboratively with other components 

within HRSA and HHS, and with other 

federal agencies, state and local 

governments, and public and private 

organizations on issues affecting Office 

programs and policies; (5) keeps 

Congress apprised of programs and 

activities as necessary; (6) links Office 

programs to HRSA-wide policy 

development, analyses, and evaluation 

as applicable; (7) serves as a key point 

of contact to coordinate, review and 

clear congressional, Executive Branch 

and other stakeholder group inquiries in 

conjunction with the agency and the 

Department; (8) serves as a key point of 

contact to coordinate activities related 

to congressional inquiries, and other 

stakeholder groups in conjunction with 

the agency and Department; and (9) 

assumes special projects or takes the 

lead on certain issues as tasked by the 

Office’s leadership. 

Division of Customer Support (RD2) 

The Division of Customer Support 

serves as the organizational focal point 

for the Office’s centralized, 

comprehensive customer service 

function to support recipients or 

potential recipients of program funds. 

The Division provides responses to 

provider inquiries that arrive at the 

Office through a variety of channels 

including providers, health delivery 

entities, stakeholders, Congress, and 

others. 

Division of Data Analytics and Program 

Integrity (RD3) 

The Division of Data Analytics and 

Program Integrity is responsible for the 

collection, management, and analysis of 

the data needed for the Provider Relief 

Fund and COVID–19 Claims 

Reimbursement to Health Care 

Providers and Facilities for Testing, 

Treatment, and Vaccine Administration 

of the Uninsured Program, and for 

ensuring the overall integrity of the 

programs and payments made. 

Specifically, the Division of Data 

Analytics and Program Integrity: (1) 

Maintains data and analytic capabilities 

to inform policy decisions and to 

support Office functions; (2) develops 

and manages Office data strategy; and 

(3) develops and manages Office 

program and payment integrity strategy. 

Chapter RC—Bureau of Primary Health 

Care 

Section RC.10 Organization 

Delete the organization for the Bureau 

of Primary Health Care (RC) in its 

entirety and replace with the following: 

The Bureau of Primary Health Care 

(RC) is headed by the Associate 

Administrator, who reports directly to 

the Administrator, HRSA. The Bureau of 

Primary Health Care (RC) includes the 

following components: 

(1) Office of the Associate 

Administrator (RC); 

(2) Division of Workforce 

Management (RC2); 

(3) Division of National Hansen’s 

Disease Program (RC4); 

(4) Office of Strategic Business 

Operations (RCA); 

(5) Office of Health Center Investment 

Oversight (RCC); 

(6) Office of Health Center Program 

Monitoring (RCF); 

(7) Office of Policy and Program 

Development (RCH); and 

(8) Office of Quality Improvement 

(RCK). 

Section RC.20 Function 

Delete the functional statement for the 

Bureau of Primary Health Care (RC) in 

its entirety and replace with the 

following: 

Bureau of Primary Health Care 

Office of the Associate Administrator 

(RC) 

Provides overall leadership, direction, 

coordination, and planning in support 

of BPHC programs. Specifically, the 

Office of the Associate Administrator: 

(1) Establishes program goals, 

objectives, and priorities, and provides 

oversight to their execution; (2) plans, 

directs, coordinates, supports, and 

evaluates bureau wide management 

activities; (3) maintains effective 

relationships within HRSA and with 

other HHS organizations, 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; and (4) manages 

the National Hansen’s Disease Program 

in accordance with regulations of the 

Public Health Service (PHS) Act. 

Division of Workforce Management 

(RC2) 

The Division of Workforce 

Management plans, directs, and 

coordinates bureau-wide administrative 

management activities and serves as the 

organizational focus for bureau 

workforce staff development and 

evaluation efforts in support of 

organizational goals and objectives. 

Specifically, the Division of Workforce 

Management: (1) Serves as the Bureau of 

Primary Health Care’s principal source 

for administrative and management 

advice, analysis, and assistance; (2) 

provides strategic guidance and 

coordinates personnel activities for the 

bureau, including the allocation of 

personnel resources; (3) develops 

policies and procedures for internal 

operations, interpreting and 

implementing management policies, 

procedures and systems; (4) develops 

and coordinates bureau program and 

administrative delegations of authority 

activities; (5) provides guidance to the 

bureau on financial management 

activities; (6) provides bureau-wide 

support services such as continuity of 

operations and emergency planning, 

procurement planning and 

coordination, supply management, 

equipment utilization, workforce 

planning, printing, property 

management, space management, and 

management reports; (7) plans and 

implements strategies for development 

of staff and succession planning; and (8) 

coordinates bureau administrative 

management and workforce activities 

with other components within HRSA 

and HHS, and with other federal 

agencies, state and local governments, 

and other public and private 

organizations, as appropriate. 

Division of National Hansen’s Disease 

Program (RC4) 

The National Hansen’s Disease 

Program, in accordance with regulations 


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and the PHS Act, Sec. 320 as amended 

by Public Law 105–78, Sec. 211, (1) 

provides care and treatment for persons 

with Hansen’s Disease (leprosy), 

including managing a national shortterm and outpatient health care delivery 

program providing specialized services 

to persons with Hansen’s Disease; (2) 

conducts and promotes the coordination 

of research (including clinical research), 

investigations, demonstrations, and 

studies relating to the causes, diagnosis, 

treatment, control, and prevention of 

Hansen’s disease and other 

mycobacterial diseases and 

complications related to such diseases; 

(3) conducts training in the diagnosis 

and management of Hansen’s disease 

and related complications; (4) provides 

education and training to staff from the 

outpatient Hansen’s Disease Clinics and 

to private physicians; (5) operates and 

oversees the National Hansen’s Disease 

Museum and Cemetery; (6) consults on 

the coordination of activities within 

HRSA and HHS and with other federal 

agencies, state, and local governments, 

and other public and private 

organizations involved in Hansen’s 

Disease activities; (7) manages a 

network of contracted outpatient clinics 

providing care to persons with Hansen’s 

Disease; and (8) manages and 

coordinates the National Hansen’s 

Disease Program’s administrative and 

operational activities with HRSA and 

HHS, other federal agencies, state and 

local governments; and other public and 

private organizations involved in 

Hansen’s Disease activities. 

Office of Strategic Business Operations 

(RCA) 

The Office of Strategic Business 

Operations serves as the organizational 

focus for the development of the Bureau 

of Primary Health Care external affairs, 

organizational data development and 

analysis, and management information 

systems to meet the goals and objectives 

of the bureau. Specifically, the Office of 

Strategic Business Operations: (1) 

Serves as the bureau’s focal point for 

communication and program 

information dissemination; (2) serves as 

the bureau’s Executive Secretariat and 

focal point for records management 

policies and guidance; (3) leads strategic 

data analytics for bureau operations; (4) 

monitors bureau activities in relation to 

HRSA and HHS Strategic Plans; (5) 

serves as the bureau focal point for the 

design and implementation of 

management information systems to 

assist and improve program 

performance and internal operations; 

and (6) consults and coordinates bureau 

external affairs, business analytics, and 

information systems with other 

components within HRSA and HHS, 

and with other federal agencies, state 

and local governments, and other public 

and private organizations. 

Office of Health Center Investment 

Oversight (RCC) 

The Office of Health Center 

Investment Oversight oversees the 

Bureau of Primary Health Care’s 

primary health care service delivery 

programs, including initiatives focused 

on special populations and associated 

activities within all HHS Regions. 

Specifically, the Office of Health Center 

Investment Oversight: (1) Oversees 

bureau primary health care service 

delivery programs for compliance with 

funding requirements; (2) monitors the 

performance of bureau primary health 

care service delivery programs, making 

programmatic recommendations and 

providing assistance to improve 

performance, where appropriate; (3) 

reviews findings, analyzes data, and 

provides recommendations through 

periodic and episodic grantee funding 

progress assessments; and (4) provides 

consultation to and coordinates 

activities within HRSA and HHS, and 

with other federal agencies, state and 

local governments, and other public and 

private organizations involved in the 

implementation of bureau primary 

health care service delivery programs. 

Office of Health Center Program 

Monitoring (RCF) 

The Office of Health Center Program 

Monitoring oversees the Bureau of 

Primary Health Care’s primary health 

care service delivery programs, 

including those focused on special 

populations, and associated activities 

within all HHS Regions. Specifically, 

the Office of Health Center Program 

Monitoring: (1) Oversees bureau 

primary health care service delivery 

programs for compliance with program 

requirements; (2) provides assistance on 

program-related statutory/regulatory 

policy and program requirements; (3) 

reviews findings, analyzes data, and 

provides recommendations through 

periodic and episodic grantee 

compliance assessments; and (4) 

provides consultation to and 

coordinates activities within HRSA and 

HHS, and with other federal agencies, 

state and local governments, and other 

public and private organizations 

involved in the implementation of 

bureau primary health care service 

delivery programs. 

Office of Policy and Program 

Development (RCH) 

The Office of Policy and Program 

Development serves as the 

organizational focus for the 

development of the Bureau of Primary 

Health Care programs and policies. 

Specifically, the Office of Policy and 

Program Development: (1) Leads and 

monitors the strategic development of 

primary care programs, including health 

centers, special population programs, 

and other health systems; (2) provides 

assistance to communities, communitybased organizations, and bureau 

programs related to the development 

and expansion of primary care; (3) 

develops bureau capital programs and 

oversees loan guarantee programs, 

including the awarding of new grants 

under section 1610(b) of the PHS Act, 

under the Health Care and Other 

Facilities grant program, and under the 

Patient Protection and Affordable Care 

Act, Public Law 111–148; (4) leads and 

coordinates the analysis, development, 

and drafting of budget and policy 

impacting bureau programs; (5) provides 

support to the National Advisory 

Council on Migrant Health; (6) performs 

environmental scanning on issues that 

affect bureau programs; and (7) consults 

and coordinates with other components 

within HRSA and HHS, and with other 

federal agencies, state and local 

governments, and other public and 

private organizations on issues affecting 

bureau programs and policies. 

Office of Quality Improvement (RCK) 

The Office of Quality Improvement 

serves as the organizational focus for 

program quality including clinical and 

operational quality improvement, 

patient safety and risk management, 

data reporting, and program evaluation. 

Specifically, the Office of Quality 

Improvement: (1) Provides leadership 

for implementing bureau clinical quality 

improvement strategies/initiatives, 

including health information 

technology; (2) oversees the bureau’s 

Federal Tort Claims Act medical 

malpractice liability programs, 

reviewing risk management and patient 

safety activities to improve policies and 

programs for primary health care 

services, including clinical information 

systems; (3) leads and coordinates the 

bureau’s national and state technical 

assistance/programs and activities, 

including those focused on special 

populations; (4) identifies, provides 

assistance, and supports bureau 

programs around quality improvement 

and performance reporting activities; (5) 

oversees bureau programs related to 

health information technology and 

quality improvement; (6) serves as the 

bureau’s focal point for the design and 

implementation of program evaluations 

and research; (7) coordinates and 

supports emergency preparedness and 


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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 


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