Statement of Organization, Functions, and Delegations of Authority, 48737-48743 [2021-18075]
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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
48737
/l-.. . .■ lJ.S. FOOD & DRUG
t
' .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-CoV-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 1s_,
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
ChiefScientist
Foctd and Drug Administration
htrps)/www,prrtewswire.com/ne\VS"teletises/cura:tivecexpantls~testirig"OPtibilSctbr-covid"l9cffoctind:.:rsv-across-,
nationwide-healthcare-delivery-network-30.1314095:.htnil
Dated: August 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
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[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
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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
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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).
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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);
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• 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
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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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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.
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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
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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
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48739
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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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)
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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);
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• 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
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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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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)
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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).
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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.
48741
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 Operations Management (RJA)
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.
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
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.
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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
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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)
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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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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
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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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
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48743
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,
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Agencies
[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48737-48743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18075]
-----------------------------------------------------------------------
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 re-establishing, 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
[[Page 48738]]
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);
[cir] Telehealth Innovation and Services Division (RA31);
Office of Special Health Initiatives (RA4);
[cir] Office of Pharmacy Affairs (RA41);
[cir] Office of Global Health (RA42);
[cir] Division of Global Programs (RA421);
Office of Planning, Analysis and Evaluation (RA5);
[cir] Division of Performance and Quality Management (RA5A);
[cir] Division of Oversight, Reporting and Regulatory Compliance
(RA5B);
[cir] Division of Data Governance and Strategic Analysis (RA5C);
[cir] 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 evidence-base 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
[[Page 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 non-governmental 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 HRSA-wide 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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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, community-based 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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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 non-federal 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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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