Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48737 

Dated: August 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18789 Filed 8–30–21; 8:45 am] 

BILLING CODE 4164–01–C 

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 

86 FR 6344–6349 dated January 21, 

2021) is amended to reorganize sections 

of the Office of the Administrator, the 

Healthcare Systems Bureau, and the 

Bureau of Primary Health Care. 

Key functional changes include reestablishing, retaining and renaming the 

Healthcare Systems Bureau to the 

Health Systems Bureau; changing the 

name of the Office of Provider Support 

to the Provider Relief Bureau; changing 

the name of the Office of Regional 


khammond on DSKJM1Z7X2PROD with NOTICESEN31AU21.042</GPH>

t /l-... . . ■ lJ.S. FOOD & DRUG ' . E .ADMINISTRAT-ION 

July 15, 2021 

Fred Turner 

Chief Executive Officer 

Curative· Inc. 

1600 Adams Drive; Suite 105 

Menlo Park, CA 94025 

Re: Revocation ofEUA2(101l2 

Deiμ- Mr .. Turner:. 

This letteris in resporute to Curative• Inc.'s (Curative) requestdated June 16, 2021, that the U.S. 

fo<>d and Drag Administta:uon (FDA) revoke the Emergency Use Ao.thmiia:til:m {EUA:200132) 

for the Curative SARS-Cbv-2Assay iss.ued on April lG; 202(}, under the original nruneCurativeKorva SARS-Covs2 Assay, and amended on June. I 1, 2020. As was also announced in its June 

16, 2021 press-release,1 Curati-ve has indicated that it ls transitioning_ to the use of different BUAauthorized SARS-Co V-2 tests: forthe testing offered at its laboratories. In itsJune 16 letter, 

Curative requested that the revocation of the Curative SARS~Co:v-2 Assiiy bil effective July 1 s_, 

2021, notins th!l.t it will no longer be in use as of July 15, 2021. 

The authorization of a device for e:metgency use under section 564 ofihe Federal Food, Drug, 

artd Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuarttto $ection. 564(g)~) of the Act, 

be revoked when circumst!l.llces make such revocati011 appropriate to protect the pμ_blic health or 

safely (section 564(g)(2)(C) of theAcQ. Because Curative has notified FDA that it will no longer 

.be using the Curative SARS..:Cov _;2 Assay as ofJuly 15, 2021. and requests FDA revoke the 

authorization effective that da:y, FDA has deterllifued that it is: appropriate to protect the public 

healih or safecy to revoke Uris authoriza:fion. Accordingly, FDAherebyrevokes: EU:A.200132 for 

the Curative SARS-Cov-2 Assay, pursuant to section 564(g)(2)(C) ofthe Act, As e>fthe date of 

this letter, the Curative SARS_;Cov-2 A:ssiiy is no lon~er authorized for emergency use by FDA. 

Notice of this rev◊cation wm be published in the Fedc.ralRMistift, pursuant. to section 564(h)(l) 

oftheAct. 

Sincerely, 

·D· en•I.S·e· I\A. brgltalfysign~cfby . (,f_\fcl••Q~μi}~M, Hint.on ·S 

Hi nto n'L§:;:;;~•t~t;X.6~.5 

RADM Denise M. Hinton 

Chief Scientist 

Foctd and Drug Administration 

1 htrps)/www,prrtewswire.com/ne\VS"teletises/cura:tivecexpantls~testirig"OPtibilSctbr-covid"l9cffoctind:.:rsv-across-, 

nationwide-healthcare-delivery-network-30.1314095:.htnil 
48738 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 

Operations to the Office of 

Intergovernmental and External Affairs; 

updating the division structure within 

the Office of Planning, Analysis and 

Evaluation; updating the organization 

and functional statement for the Office 

of Federal Assistance Management; and 

realigning the external engagement 

function from the Office of Planning, 

Analysis and Evaluation and the Tribal 

Affairs activities from the Office of 

Health Equity to the renamed Office of 

Intergovernmental and External Affairs. 

This reorganization establishes, 

updates, realigns, and/or deletes the 

organization, functions, and delegation 

of authority for the (1) Health Resources 

and Services Administration (R); (2) 

Office of the Administrator (RA); (3) 

Office for the Advancement of 

Telehealth (RA3); (4) Office of Special 

Health Initiatives (RA4); (5) Office of 

Planning, Analysis and Evaluation 

(RA5); (6) Office of Provider Support 

(RD); (6) Bureau of Primary Health Care 

(RC); (7) Office of Federal Assistance 

Management (RJ); (8) Office of Regional 

Operations; and (9) Healthcare Systems 

Bureau (RR). 

Chapter R—Health Resources and 

Services Administration 

Section R.10 Organization 

Delete the organization for the Health 

Resources and Services Administration 

(R) in its entirety and replace with the 

following: 

The Health Resources and Services 

Administration (R) is headed by the 

Administrator, who reports directly to 

the Secretary, HHS. The Health 

Resources and Services Administration 

includes the following components: 

• Office of the Administrator (RA); 

• Office of Operations (RB); 

• Office of Federal Assistance 

Management (RJ); 

• Office of Intergovernmental and 

External Affairs (RE); 

• Bureau of Health Workforce (RQ); 

• Bureau of Primary Health Care (RC); 

• HIV/AIDS Bureau (RV); 

• Federal Office of Rural Health 

Policy (RH); 

• Health Systems Bureau (RR); 

• Maternal and Child Health Bureau 

(RM); and 

• Provider Relief Bureau (RD). 

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: 

• Immediate Office of the 

Administrator (RA); 

• Office of Civil Rights, Diversity and 

Inclusion (RA2); 

• Office for the Advancement of 

Telehealth (RA3); 

Æ Telehealth Innovation and Services 

Division (RA31); 

• Office of Special Health Initiatives 

(RA4); 

Æ Office of Pharmacy Affairs (RA41); 

Æ Office of Global Health (RA42); 

Æ Division of Global Programs 

(RA421); 

• Office of Planning, Analysis and 

Evaluation (RA5); 

Æ Division of Performance and 

Quality Management (RA5A); 

Æ Division of Oversight, Reporting 

and Regulatory Compliance (RA5B); 

Æ Division of Data Governance and 

Strategic Analysis (RA5C); 

Æ Division of Strategic Initiatives 

(RA5D); 

• Office of Communications (RA6); 

• Office of Legislation (RAE); 

• Office of Health Equity (RAB); and 

• Office of Women’s Health (RAW). 

Section RA.20 Function 

(1) Delete the functional statement for 

the Immediate Office of the 

Administrator (RA) in its entirety and 

replace; (2) delete the functional 

statement for the Office for the 

Advancement of Telehealth (RA3) in its 

entirety and replace; (3) delete the 

functional statement for the Office of 

Special Health Initiatives, Office of the 

Director (RA4) and replace; (4) delete 

the functional statement for Division of 

Injury Compensation Programs and 

move to the Health Systems Bureau 

(RR); and (5) delete the functional 

statement for the Office of Planning 

Analysis, and Evaluation (RA5) in its 

entirety and replace. 

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, including the President’s 

Emergency Plan For AIDS Relief 

(PEPFAR); (10) administers PEPFAR 

grants and oversees HRSA’s 

implementation of PEPFAR funding and 

activities; (11) leads HRSA’s efforts to 

improve the health, wellness, and safety 

of women and girls through policy, 

programming and outreach/education; 

(12) provides leadership and policy 

development in the administration of 

the 340B Drug Pricing Program; (13) 

implements efforts to advance health 

equity in HRSA programs; and (14) 

provides cross-cutting leadership on 

HRSA’s behavioral health and oral 

health programs. 

Office for the Advancement of 

Telehealth (RA3) 

Office of the Director (RA3) 

The Office for the Advancement of 

Telehealth (1) promotes the use of 

telehealth technologies for health care 

delivery, education, and health 

information services; (2) serves as the 

central focal point for the Department of 

Health and Human Services (HHS) 

efforts in leveraging telehealth programs 

and policies to improve access, enhance 

outcomes, and support clinicians and 

patients; (3) administers grant programs 

focused on telehealth for direct services, 

research, and technical assistance; (4) 

advances the provision of telehealth 

services to rural and underserved 

communities; (5) builds the evidencebase for telehealth research; (6) manages 

Telehealth.HHS.gov as the HHS hub for 

telehealth resources for both patients 

and health care providers; (7) 

collaborates with HHS components and 

other federal agencies to improve access 

to telehealth and broadband services; (8) 

provides overall direction and 

leadership over the management of 

programs to advance the use of 

telehealth; (9) provides professional 

assistance and support in developing 

telehealth initiatives; (10) 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 to leverage 

telehealth to improve access to care, 

enhance outcomes, and support 

clinicians and patients; (11) promotes 


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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48739 

the use of telehealth technologies for 

health care delivery, education and 

health information services; and (12) 

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. 

Telehealth Innovation and Services 

Division (RA31) 

The Telehealth Innovation and 

Services Division serves as the focal 

point in the Office for the Advancement 

of Telehealth to support innovative 

grant programs for direct services and 

technical assistance in the field of 

telehealth. Specifically, the Telehealth 

Services Division carries out the 

following functions: (1) Develops and 

coordinates telehealth network grant 

programs, telehealth resource center 

grant programs, the telehealth centers of 

excellence, the licensure portability 

grant program, and the telehealth 

broadband pilot program; (2) 

administers grant programs to 

promulgate and evaluate the use of 

appropriate telehealth technologies 

among HRSA grantees and others; (3) 

monitors the performance of telehealth 

grant programs, making programmatic 

recommendations and providing 

assistance to improve performance, 

where appropriate; (4) coordinates and 

provides technical assistance and 

expertise to grantees of funded 

programs; and (5) develops funding 

opportunity announcements and 

program guidance documents. 

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 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; and (5) provides cross-cutting 

leadership on HRSA oral health 

programs. 

Office of Planning, Analysis and 

Evaluation (RA5) 

Office of the Director (RA5) 

The Office of Planning, Analysis and 

Evaluation provides (1) agency-wide 

leadership for performance management 

and data governance; (2) directs the 

agency’s long term strategic planning 

process; (3) conducts and/or guides 

analyses, research, and program 

evaluation; (4) facilitates policy 

development by serving as the analytic 

liaison between the Administrator, other 

Operating/Staff Divisions, Office of the 

Secretary staff components, and other 

Departments on critical matters 

involving agency program policies; (5) 

provides oversight and coordination of 

program performance reports and plans, 

including to the Department and OMB; 

(6) provides support, agency direction, 

and leadership for HRSA’s data-driven, 

health quality efforts; (7) coordinates the 

agency’s participation in Department 

and federal strategic initiatives related 

to organizational performance and 

implementation of executive directives; 

(8) coordinates HRSA innovation 

activities across the agency and with 

HHS Operating/Staff Divisions to 

support HRSA programs and operations; 

(9) provides data-driven technical 

assistance to agency programs in order 

to help them respond to emerging issues 

affecting the health care safety net; (10) 

conducts special studies and analyses 

and/or provides analytic support and 

information to support the agency’s 

goals and directions; (11) oversees and 

coordinates HRSA innovation activities, 

including the identification of agency 

capability gaps and potential solutions 

to fill the gaps; (12) directs life cycle 

management of innovation pilot 

programs and challenge competitions; 

(13) provides technical assistance to 

HRSA divisions in the identification of 

areas for innovation, including funding 

and solution development; (14) 

collaborates with other HHS agencies to 

promote innovation and resource 

sharing; and (15) leads external 

innovation partnership development to 

enhance HRSA staff awareness of nongovernmental innovations that could 

benefit the agency. 

Division of Performance and Quality 

Management (RA5A) 

The Division of Performance and 

Quality Management (1) serves as the 

principal agency resource for 

performance and quality measurement 

(2) leads HRSA implementation of 

program performance-related 

legislation; (3) produces regular HRSAwide program performance reports and 

plans in compliance legislative, OMB, 

and departmental directives; (4) assists 

HRSA divisions in the selection, 

development, maintenance, and 

alignment of performance measures; (5) 

leads HRSA strategic planning processes 

and serves as primary liaison to HHS in 

the development of the Department’s 

strategic plan and associated 

requirements; (6) provides support, 

policy direction, and leadership for 

HRSA’s health quality measurement 

efforts; (7) collaborates with other HHS 

agencies to promote improvements in 

the availability of performance- and 

quality-related information; (8) serves as 

HRSA liaison to the Department in the 

development of HHS research and 

evaluation initiatives; (9) coordinates 

HRSA’s survey activities; (10) conducts, 

guides, and/or participates in major 

program evaluation efforts and prepares 

reports on HRSA program efficiencies; 

(11) coordinates the HRSA-wide 

evaluation resource investments; (12) 

performs technical assistance to support 

HRSA program staff develop and 

implement program evaluations, and 

(13) coordinates HRSA input for the 

Healthy People initiative. 

Division of Oversight, Reporting and 

Regulatory Compliance (RA5B) 

The Division of Oversight, Reporting 

and Regulatory Compliance (1) serves as 

the agency liaison to manage and 

coordinate study engagements with the 

Government Accountability Office and 

the HHS Office of the Inspector General, 

Office of Evaluation and Inspections; (2) 

manages coordination with the 

Department and OMB for oversight, 

reporting, and compliance policies, 

engagements, and requirements; (3) 

provides technical assistance to support 

HRSA program staff development to 

meet compliance-related reporting 

requirements; (4) coordinates HRSA 

participation in institutional review 

boards, the protection of human 

subjects, and serves as the agency’s 

Privacy Act Officer; (5) manages HRSA 

activity related to the Paperwork 

Reduction Act, and other OMB policies; 

(6) leads the Data Disclosure Review 

Board; and (7) serves as the agency lead 

to oversee development and 

management of Agency Data Use 

Agreements. 

Division of Data Governance and 

Strategic Analysis (RA5C) 

The Division of Data Governance and 

Strategic Analysis (1) leads 


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48740 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 

development and implementation of the 

HRSA Data Strategic Plan; (2) serves as 

the agency lead in the coordination of 

all data governance and analytics; (3) 

analyzes and coordinates HRSA’s need 

for information and data for use in the 

management and direction of agency 

programs; (4) catalyzes new capabilities 

in data-related activities by providing 

agency leadership and coordination; (5) 

maintains an inventory of HRSA 

databases; (6) promotes the availability 

of HRSA data through websites and 

other on-line applications; (7) serves as 

the principal agency resource for policy 

analysis; (8) analyzes issues arising from 

legislation, budget proposals, regulatory 

actions, and other program or policy 

actions; (9) serves as focal point within 

HRSA for analysis of health care 

payment systems and financing issues; 

(10) conducts HRSA-wide trainings on 

health care policy and financing issues; 

and (11) collaborates with HHS 

Operating/Staff Divisions to examine 

the impact of Medicare, Medicaid, and 

Children’s Health Insurance Program on 

HRSA grantees and safety net providers. 

Division of Strategic Initiatives (RA5D) 

The Division of Strategic Initiatives 

(1) provides HRSA-wide leadership on 

cross-agency initiatives and 

departmental priorities; (2) serves as 

agency lead and liaison between the 

Administrator, other Operating/Staff 

Divisions, Office of the Secretary staff 

components, and other Departments on 

priority initiatives; (3) provides 

technical assistance to agency programs 

in order to help them respond to 

emerging issues affecting the health care 

safety net; and (4) provides agency 

leadership and guidance on policy 

development. 

Chapter RC—Bureau of Primary Health 

Care (RC) 

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: 

• Office of the Associate 

Administrator (RC); 

• Division of Workforce Management 

(RC2); 

• Office of Strategic Business 

Operations (RCA); 

• Office of Health Center Investment 

Oversight (RCC); 

• Office of Health Center Program 

Monitoring (RCF); 

• Office of Policy and Program 

Development (RCH); and 

• Office of Quality Improvement 

(RCK). 

Section RC.20 Function 

(1) Delete the functional statement for 

the Office of the Associate 

Administrator and replace in its 

entirety; (2) delete the functional 

statement for the Office of Policy and 

Program Development (RCH); and (3) 

delete the functional statement for the 

Division of National Hansen’s Disease 

Program (RC4) and move to the Health 

Systems Bureau (RR). 

Office of the Associate Administrator 

(RC) 

Provides overall leadership, direction, 

coordination, and planning in support 

of the Bureau of Primary Health Care’s 

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; and 

(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. 

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; (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. 

Chapter RD—Provider Relief Bureau 

(RD) 

Section RD.10 Organization 

Rename the Office of Provider 

Support to the Provider Relief Bureau. 

The Provider Relief Bureau (RD) is 

headed by the Associate Administrator, 

who reports directly to the 

Administrator, HRSA. The Provider 

Relief Bureau includes the following 

components: 

• Office of the Associate 

Administrator (RD); 

• Division of Policy and Program 

Operations (RD1); 

• Division of Customer Support 

(RD2); and 

• Division of Data Analytics and 

Program Integrity (RD3). 

Chapter RE—Office of 

Intergovernmental and External Affairs 

(RE) 

Section RE.10 Organization 

Rename the Office of Regional 

Operations to the Office of 

Intergovernmental and External Affairs 

(RE). 

The Office of Intergovernmental and 

External Affairs (RE) is headed by the 

Associate Administrator, who reports 

directly to the Administrator, HRSA, 

and includes the following components: 

• Office of the Associate 

Administrator (RE); 

• Boston Regional Office (RE1); 

• New York Regional Office (RE2); 

• Philadelphia Regional Office (RE3); 

• Atlanta Regional Office (RE4); 

• Chicago Regional Office (RE5); 

• Dallas Regional Office (RE6); 

• Kansas City Regional Office (RE7); 

• Denver Regional Office (RE8); 

• San Francisco Regional Office 

(RE9); and 

• Seattle Regional Office (RE10). 

Section RE.20 Function 

Delete the functional statement for the 

Office of Regional Operations and 

replace with the following: 

Office of Intergovernmental and 

External Affairs (RE) 

The Office of Intergovernmental and 

External Affairs serves as the principal 

Agency lead on intergovernmental and 

external affairs, regional operations, and 

tribal partnerships. The Office serves as 

the Agency liaison to the HHS Office of 

Intergovernmental and External Affairs. 

Specifically, the Office: (1) Provides the 

HRSA Administrator and agency 

leadership with a single point of contact 


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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48741 

on all intergovernmental, stakeholder 

associations, and interest groups 

activities; (2) serves as the primary 

liaison to Department and other federal 

intergovernmental staff; (3) manages 

agency cross-Bureau cooperative 

agreements and activities with national 

organizations of state and local health 

leaders and elected officials; (4) 

coordinates tribal activities across the 

agency and strengthens HRSA’s unique 

relationships with tribes; (5) coordinates 

HRSA activities with regional 

commissions, such as the Delta, 

Appalachian, Denali and Border Health 

commissions; (6) functions as the 

regional component of HRSA by 

providing leadership on HRSA’s 

mission and priorities across 

headquarters, regions, states, tribes, 

territories, and local communities; (7) 

conducts outreach to expand knowledge 

of HRSA’s programs to advance agency 

and Department priorities; (8) generates 

and sustains collaborative efforts with 

state and jurisdictional health care 

leaders to align HRSA and other 

resources; (9) presents regional 

surveillance and analysis of health care 

trends and makes recommendations to 

HRSA leadership, government officials 

and stakeholders to improve policies 

and programs; (10) exercises 

management authority for general 

administration of HRSA’s regional 

offices; and (11) manages HRSA’s Tribal 

Advisory Council, participates in HHS 

Tribal Consultations and collaborates 

with IHS and other federal and 

community stakeholders to address 

tribal issues. 

Chapter RJ—Office of Federal 

Assistance Management (RJ) 

Section RJ.10 Organization 

Delete the organization for the Office 

of Federal Assistance Management (RJ) 

in its entirety and replace with the 

following: 

The Office of Federal Assistance 

Management (RJ) is headed by the 

Associate Administrator, who reports 

directly to the Administrator, HRSA. 

The Office of Federal Assistance 

Management includes the following 

components: 

• Office of the Associate 

Administrator (RJ); 

• Office of Operations Management 

(RJA); 

• Office of Systems and Data (RJB); 

• Division of Financial Integrity (RJ1); 

• Division of Grants Policy and 

Planning (RJ2); 

• Division of Grants Management 

Operations (RJ3); and 

• Division of Independent Review 

(RJ4). 

Section RJ.20 Function 

Delete the functional statement for the 

Office of the Federal Assistance 

Management (RJ) in its entirety and 

replace: 

Office of Federal Assistance 

Management (RJ) 

The Office of Federal Assistance 

Management (OFAM) provides national 

leadership in the administration and 

assurance of the financial integrity of 

HRSA’s programs. Provides leadership, 

direction, and coordination to all phases 

of grants policy, administration, and 

independent review of Competitive 

grant applications. Specifically, OFAM: 

(1) Serves as the Administrator’s 

principal source for grants policy and 

financial integrity of HRSA programs; 

(2) exercises oversight over the agency’s 

business processes related to assistance 

programs; (3) facilitates, plans, directs, 

and coordinates the administration of 

HRSA grant policies and operations; (4) 

directs and carries out the independent 

review of grant applications for all of 

HRSA’s programs; (5) exercises the 

responsibility within HRSA for grant 

and cooperative agreement receipt, 

award, and post-award processes; and 

(6) plans, directs plus manages the 

electronic systems and business 

operations that enable staff to perform 

their day-to-day work. 

Office of Operations Management (RJA) 

The Office of Operations Management 

provides OFAM-wide strategic 

organizational management and 

direction. Plans, directs and coordinates 

OFAM-wide business operations and 

administrative management activities. 

Specifically, the Office of Operations 

Management: (1) Serves as the principal 

source for administrative operations 

advice and assistance; (2) provides 

guidance and coordinates personnel 

activities for OFAM; (3) provides 

organization and management analysis, 

coordinating the allocation of personnel 

resources, developing policies and 

procedures for internal operations, 

interpreting and implementing OFAM 

management policies and procedures 

and systems; (4) develops and 

coordinates OFAM administrative 

delegations of authority activities (5) 

lead, plan, and coordinate all OFAM 

budgetary activities, such as contacts, 

procurements and inter-agency 

agreements, as well as, provides 

guidance and support to OFAM 

leadership in these areas; (6) provides 

OFAM-wide support services such as 

acquisition support, travel coordination, 

supply management, equipment 

utilization, printing, property 

management, space management, 

records management, and management 

reports; (7) coordinates OFAM 

administrative management activities 

with other components within HRSA 

and HHS, and with other federal 

agencies, as appropriate; and (8) 

provides overall support for OFAM’s 

continuity of operations and emergency 

support. 

Office of Systems and Data (RJB) 

The Office of Systems and Data 

provides strategic management and 

direction for OFAM-wide efforts 

addressing data analysis, evaluation and 

systems. Specifically, the Office of 

Systems and Data: (1) Coordinates and 

analyzes the agency’s need for federal 

assistance data for all programs; (2) 

collects federal assistance data to 

quantify and measure financial 

assistance data for evaluation at the 

national level (3) provides coordination 

and strategic guidance for OFAM’s 

Management of the Electronic 

Handbook, Grants.gov, and other 

Information Technology systems; (4) 

coordinates OFAM’s Electronic 

Handbook data requests, dashboard and 

report development; and provides 

guidance on data management laws, 

regulations, governances and policy; (5) 

develops and manages OFAM 

performance measures; and (6) manages 

and maintains current data on all 

electronic sites. 

Division of Financial Integrity (RJ1) 

The Division of Financial Integrity: (1) 

Coordinates agency-wide efforts 

addressing HHS’s Program Integrity 

Initiative/Enterprise Risk Management; 

(2) serves as the agency’s focal point for 

resolving audit findings on HRSA 

programs resulting from the Single 

Audits and special reviews; (3) conducts 

financial and compliance reviews of 

non-federal entities use of HRSA funds; 

(4) conducts the pre-award financial 

assessment of HRSA non-federal 

entities; (5) conducts the pre-award and 

post-award review of grant applicant’s 

and non-federal entities financial 

soundness and management including 

accounting systems for managing federal 

grants; (6) conducts ad hoc studies and 

reviews related to the financial integrity 

of the HRSA business processes related 

to assistance programs; (7) serves as the 

agency’s liaison with the Office of 

Inspector General for issues related to 

HRSA programs; (8) coordinates nonfederal entities appeal actions for the 

Department on HRSA decisions related 

to HRSA programs; (9) coordinates the 

preparation of informational reports on 

high risk non-federal entities; (10) 

coordinates contractor audit/financial 


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assessment assignments; (11) responds 

to data requests; (12) serves as the HRSA 

liaison with the Department on the 

Single Audit Compliance Supplement 

update; (13) conducts internal audits; 

and (14) serves as the outreach to HRSA 

staff and non-federal entities to increase 

monitoring efforts for non-federal 

entities. 

Division of Grants Policy and Planning 

(RJ2) 

The Division of Grants Policy and 

Planning analyzes, develops and 

implements HRSA’s federal assistance 

award policy in compliance with 

statutes, regulations, Government-wide 

administrative requirements and 

Departmental policy. The Division 

recommends internal procedures to 

ensure consistent and effective 

stewardship of taxpayer dollars. 

Division of Grants Management 

Operations (RJ3) 

The Division of Grants Management 

Operations exercises responsibility 

within HRSA for all business aspects of 

grant and cooperative agreement award 

and post-award processes, and 

participates in the planning, 

development, and implementation of 

policies and procedures for grants and 

other federal financial assistance 

mechanisms. Specifically, the Division 

of Grants Management Operations: (1) 

Plans, directs and carries out the grants 

officer functions for all of HRSA’s grant 

programs as well as awarding official 

functions for various scholarship, loan, 

and loan repayment assistance 

programs; (2) participates in the 

planning, development, and 

implementation of policies and 

procedures for grants and cooperative 

agreements; (3) provides assistance and 

technical consultation to program 

offices and grantees in the application of 

laws, regulations, policies, and 

guidelines relative to the agency’s grant 

and cooperative agreement programs; (4) 

develops standard operating procedures, 

methods, and materials for the 

administration of the agency’s grants 

programs; (5) establishes standards and 

guides for grants management 

operations; (6) reviews grantee financial 

status reports and prepares reports and 

analyses on the grantee’s use of funds; 

(7) provides technical assistance to 

applicants and grantees on financial and 

administrative aspects of grant projects; 

(8) provides data and analyses as 

necessary for budget planning, hearings, 

operational planning, and management 

decisions; (9) participates in the 

development of program guidance and 

instructions for grant competitions; (10) 

oversees contracts in support of receipt 

of applications, records management, 

and grant closeout operations; and (11) 

supports post-award monitoring and 

closeout by analyzing payment 

management system data and working 

with grants and program office staff. 

Division of Independent Review (RJ4) 

The Division of Independent Review 

is responsible for the management and 

oversight of HRSA’s independent 

review of grant and cooperative 

agreement applications for funding. 

Specifically, the Division of 

Independent Review: (1) Plans, directs, 

and carries out HRSA’s independent 

review of applications for grants and 

cooperative agreement funding, and 

assures that the process is fair, open, 

and competitive; (2) develops, 

implements, and maintains policies and 

procedures necessary to carry out the 

agency’s independent review/peer 

review processes; (3) provides technical 

assistance to independent reviewers 

ensuring that reviewers are aware of and 

comply with appropriate administrative 

policies and regulations; (4) provides 

technical advice and guidance to the 

agency regarding the independent 

review processes; (5) coordinates and 

assures the development of program 

policies and rules relating to HRSA’s 

extramural grant activities; and (6) 

provides HRSA’s Offices and Bureaus 

with the final disposition of all 

reviewed applications. 

Chapter RR—Health Systems Bureau 

Section RR.10 Organization 

Re-establish, retain and rename the 

Health Systems Bureau (RR). The Health 

Systems Bureau (RR) is headed by the 

Associate Administrator, who reports 

directly to the Administrator, HRSA. 

The Health Systems Bureau (RR) 

includes the following components: 

• Office of the Associate 

Administrator (RR); 

• Division of Transplantation (RR1); 

• Division of Injury Compensation 

Programs (RR4); and 

• Division of National Hansen’s 

Disease Program (RRH). 

Section RR.20 Function 

Establish the following functional 

statement for the Health Systems Bureau 

(RR): 

Office of the Associate Administrator 

(RR) 

The Health Systems Bureau leads the 

agency in providing health care 

programs to eligible organizations 

around the country. Specifically, the 

Health Systems Bureau (1) oversees the 

implementation of blood stem cell and 

organ transplantation programs; (2) 

manages the national program for 

compliance with the Hill-Burton 

uncompensated care requirement and 

other assurances; (3) administers 

community based and other grant 

awards; (4) directs and administers the 

National Vaccine Injury Compensation 

Program; (5) implements and 

administers the Countermeasures Injury 

Compensation Program; (6) provides 

professional and administrative support 

for the HHS Medical Review Claims 

Panel; and (7) manages the National 

Hansen’s Disease Program in accordance 

with regulations of the Public Health 

Service. 

Division of Transplantation (RR1) 

The Division of Transplantation, on 

behalf of the Secretary of Health and 

Human Services, administers national 

systems to facilitate solid organ and 

blood stem cell transplantation 

including: The Organ Transplantation 

Program, the C.W. Bill Young Cell 

Transplantation Program, the National 

Cord Blood Inventory, cross-cutting 

medical activities, and the breakthrough 

collaborative to increase the number of 

deceased donor organs made available 

for transplantation. 

Division of Injury Compensation 

Programs (RR4) 

The Division of Injury Compensation 

Programs, on behalf of the Secretary of 

HHS, 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; (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 


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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48743 

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; (11) 

providing programmatic outreach efforts 

to maximize public exposure to private 

and public constituencies; and (12) 

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. 

Division of National Hansen’s Disease 

Program (RRH) 

The National Hansen’s Disease 

Program, in accordance with regulations 

and the Public Health Service (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 short-term 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; and (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. 

Section R.30 Delegation of Authority 

All prior delegations of authority and 

re-delegations of authority consistent 

with this reorganization are in effect. I 

affirm and ratify any actions taken by 

HHS officials that involved the exercise 

of those authorities prior to the effective 

date of this reorganization. 

(Authority: 44 U.S.C. 3101) 

Dated: August 6, 2021. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2021–18075 Filed 8–27–21; 4:15 pm] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: Data System 

for Organ Procurement and 

Transplantation Network, OMB No. 

0915–0157—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for the opportunity for 

public comment on proposed data 

collection projects of the Paperwork 

Reduction Act of 1995, HRSA 

announces plans to submit an 

Information Collection Request (ICR), 

described below, to the Office of 

Management and Budget (OMB). Prior 

to submitting the ICR to OMB, HRSA 

seeks comments from the public 

regarding the burden estimate, below, or 

any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than November 1, 

2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Data System for Organ Procurement and 

Transplantation Network, OMB No. 

0915–0157—Revision. 

Abstract: Section 372 of the Public 

Health Service Act requires that the 

Secretary, by contract, provide for the 

establishment and operation of a 

private, non-profit entity: The Organ 

Procurement and Transplantation 

Network (OPTN). The data collected 

pursuant to the OPTN’s regulatory 

authority in 42 CFR 121.11 of the OPTN 

Final Rule is collected through OMB 

approved data collection forms. 

Therefore, data approved for collection 

by the OPTN Board of Directors are 

submitted by HRSA for OMB approval 

under the Paperwork Reduction Act of 

1995. 

This is a request for revising the 

current OPTN data collection associated 

with an individual’s clinical 

characteristics at the time of 

registration, transplant, and follow-up 

after the transplant to include data 

collection forms in the OPTN Organ 

Labeling, Packaging, and Tracking 

System, the OPTN Kidney Paired 

Donation Pilot Program (KPDPP), and 

the OPTN Patient Safety Reporting 

Portal (PSRP). This revision also 

includes OPTN Board of Directors 

approved changes to the existing OMB 

data collection forms. These specific 

data elements of the OPTN data system 

are collected from transplant hospitals, 

organ procurement organizations, and 

histocompatibility laboratories. The 

information is used to (1) facilitate 

organ placement and match donor 

organs with recipients; (2) monitor 

compliance of member organizations 

with Federal laws and regulations and 

with OPTN requirements; (3) review 

and report periodically to the public on 

the status of organ donation and 

transplantation in the United States; (4) 

provide data to researchers and 

government agencies to study the 

scientific and clinical status of organ 

transplantation; (5) perform 

transplantation-related public health 

surveillance including the possible 

transmission of donor disease. 

HRSA is submitting the following 

changes to improve the OPTN organ 

matching and allocation process and 

improve OPTN member compliance 

with OPTN requirements. All of these 

proposed changes have been approved 

by the OPTN Board of Directors. 

(1) Adding two data collection forms 

for the OPTN Organ Labeling, 

Packaging, and Tracking System to the 

existing OMB approved Data System for 

Organ Procurement and Transplantation 

Network. The system has two forms that 

are used through mobile and web-based 

applications to ensure the correct organ 

is transplanted into the correct patient, 

minimize labeling and transport errors, 

accelerate organ information transfer, 


khammond on DSKJM1Z7X2PROD with NOTICES