7346 Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 

expertise. For supervision deliberations, 

the Panel shall also include members 

that represent the interests of Critical 

Access Hospitals (CAHs), who advice 

Centers for Medicare & Medicaid 

Services (CMS) only regarding the level 

of supervision for hospital outpatient 

therapeutic services. 

New appointments are made in a 

manner that ensures a balanced 

membership under the FACA 

guidelines. 

The Panel presently consists of the 

following members and a Chair. 

(Note: The asterisk [*] indicates the 

Panel members whose terms end during 

CY 2016, along with the month that the 

term ends.) 

• E. L. Hambrick, M.D., J.D., Chair, a 

CMS Medical Officer. 

• Karen Borman, M.D., 

F.A.C.S.*(January 2016) 

• Dawn L. Francis, M.D., M.H.S. 

• Ruth Lande 

• Jim Nelson, M.B.A., C.P.A., 

F.H.F.M.A.*(January 2016) 

• Leah Osbahr, M.A., M.P.H.* 

(January 2016) 

• Jacqueline Phillips*(February 2016) 

• Johnathan Pregler, M.D. 

• Traci Rabine*(January 2016) 

• Michael Rabovsky, M.D. 

• Wendy Resnick, F.H.F.M.A. 

• Michael K. Schroyer, R.N. 

• Marianna V. Spanki-Varelas M.D., 

Ph.D., M.B.A.*(February 2016) 

• Norman Thomson, III, M.D. 

• Gale Walker*(January 2016) 

• Kris Zimmer 

II. Provisions of the Notice 

We published a notice in the Federal 

Register on August 28, 2015, entitled 

‘‘Medicare Program; Solicitation of 

Nominations to the Advisory Panel on 

Hospital Outpatient Payment (80 FR 

52294). The notice solicited 

nominations for up to seven new 

members to fill the vacancies on the 

Panel beginning in CY 2016. As a result 

of that notice, we are announcing seven 

new members to the Panel. The Panel 

consists of a Chair and 15 members. The 

seven new Panel member appointments 

are for 4-year terms beginning March 1, 

2016 and will assure that we continue 

to have a Chair and 15 members 

available to attend our scheduled 

meeting. 

New Appointments to the Panel 

New members of the Panel will have 

terms beginning on March 1, 2016 and 

continuing through February 28, 2020 as 

follows: 

• Shelly Dunham, R.N. 

• Kenneth Michael Flowe, M.D., 

M.B.A. 

• Erika Hardy, R.H.I.A. 

• Karen A. Lambert 

• Scott Manaker, M.D., Ph.D. 

• Agatha L. Nolen, Ph.D., D.Ph. 

• Richard Nordahl, M.B.A. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

Dated: February 2, 2016. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2016–02798 Filed 2–10–16; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of the Assistant Secretary, 

Office of the Deputy Assistant 

Secretary for Early Childhood 

Development, Office of Head Start, 

Office of Child Care; Statement of 

Organization, Functions, and 

Delegations of Authority 

AGENCY: Administration for Children 

and Families, HHS. 

ACTION: Notice. 

SUMMARY: Statement of organization, 

functions, and delegations of authority. 

The Administration for Children and 

Families (ACF) has reorganized the 

Office of the Deputy Assistant Secretary 

for Early Childhood Development 

(ODAS–ECD) within the Office of the 

Assistant Secretary (OAS), the Office of 

Head Start (OHS), and the Office of 

Child Care (OCC). This reorganization 

will transfer reporting authority of OCC 

and OHS in their entirety from OAS to 

the ODAS–ECD. This reorganization 

creates within ODAS–ECD the Division 

of Policy and Budget; the Division of 

Comprehensive Services and Training 

and Technical Assistance; the Division 

of Research, Analysis, and 

Communications; and the Division of 

Interagency and Special Initiatives. 

Additionally, this reorganization will 

realign and combine several functions 

currently separately managed within 

OHS, OCC, and ODAS–ECD. 

The ODAS–ECD reviewed the 

programmatic and administrative 

similarities and differences between 

OHS and OCC and is proposing a new 

organizational structure that will not 

only retain the autonomy of the Head 

Start and Child Care programs and 

retain the best parts of how they provide 

services, but will also demonstrate a 

clear message to the field about the 

alignment of the Head Start and Child 

Care program offices, the unified focus 

of ensuring children receive quality 

services regardless of their program 

option, and a common message about 

the quality and expectations for services 

to children and families. 

Internally, the proposed 

reorganization will generate a more 

integrated alignment of standards 

through Head Start and Child Care 

programs, the development of a unified 

training and technical assistance 

system, consistent access to resources at 

the ACF level for both programs, and a 

shared use of research resources and 

agenda. Additionally, the proposed 

reorganization will result in greater 

collaborative efforts among both offices 

thereby leveraging best practices across 

both offices (monitoring, program 

outreach, content development, etc.). 

Moreover, both staffs will gain a broader 

understanding of the early childhood 

field and the inter-dependencies 

between programs. 

Within OHS, this reorganization 

eliminates the Education and 

Comprehensive Services Division and 

moves some of the functions to the 

newly created Division of 

Comprehensive Services and Training 

and Technical Assistance and the 

Division of Research, Analysis, and 

Communications within ODAS–ECD. It 

eliminates the Policy and Planning 

Division in OHS and moves some of 

those functions to the newly created 

Division of Policy and Budget within 

ODAS–ECD and to a new OHS Division 

of Planning, Oversight, and Policy. It 

eliminates the State Initiatives Division 

in OHS and moves some of those 

functions to each of the newly created 

Division of Interagency and Special 

Initiatives and the Division of 

Comprehensive Services and Training 

and Technical Assistance within 

ODAS–ECD. It also deletes the Grants 

and Contracts Division in OHS and 

moves the functions to two newly 

created and separate Divisions within 

OHS—the Division of Contracts and the 

Division of Grants. It combines the 

previous OHS Quality Assurance 

Division and OHS Policy and Planning 

Division to create the OHS Division of 

Planning, Oversight, and Policy. The 

OHS Program Operations Division 

remains the OHS Division of Program 

Operations. 

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Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 7347 

Within OCC, this reorganization 

eliminates the Division of Technical 

Assistance and moves most of its 

functions to the newly created Division 

of Comprehensive Services and Training 

and Technical Assistance within 

ODAS–ECD. It also eliminates the 

Division of Policy in OCC and moves 

some of those functions to the newly 

created Division of Policy and Budget 

within ODAS–ECD and to the new OCC 

Division of Planning, Data, and Policy. 

Within OCC, it creates a new Division— 

the Division of Oversight and 

Accountability. The OCC Division of 

Program Operations remains the 

Division of Program Operations. 

The goal of this reorganization is to 

more closely align early childhood 

programs, policies, and support 

functions in order to improve 

collaboration between OHS, OCC, and 

other federal agencies as appropriate. 

This will leverage best practices, 

generating more integrated and aligned 

standards through Head Start and Child 

Care, and improving access to ACF 

resources for OHS and OCC grantees 

while fully supporting the fundamental 

responsibility of operating Head Start 

and the Child Care and Development 

Fund to ensure the authorized purposes 

of each program and its funding are 

fully realized. 

This notice amends Part K of the 

Statement of Organization Functions, 

and Delegations of Authority of the 

Department of Health and Human 

Services, Administration for Children 

and Families: Chapter K, 

Administration for Children and 

Families, as last amended 77 FR 23250– 

23260, April 18, 2012; Chapter KA, 

Office of the Assistant Secretary, as last 

amended 80 FR 33269–33270, June 11, 

2015, and 75 FR 60471–60473, 

September 30, 2010; Chapter KU, Office 

of Head Start (OHS), as last amended 75 

FR 81280–81282, December 27, 2010; 

Chapter KV, Office of Child Care (OCC) 

as last amended 75 FR 60471–60473, 

September 30, 2010. 

I. Amend Chapter K, Administration 

for Children and Families, as follows: 

A. Delete Section K.10, 

Administration for Children and 

Families, in its entirety and replace with 

the following: 

K.10 Organization. The 

Administration for Children and 

Families (ACF) is a principal operating 

division of the Department of Health 

and Human Services (HHS). The 

Administration is headed by the 

Assistant Secretary for Children and 

Families, who reports directly to the 

Secretary. The Assistant Secretary also 

serves as the Director of Child Support 

Enforcement. In addition to the 

Assistant Secretary, the Administration 

consists of the Principal Deputy 

Assistant Secretary, the Deputy 

Assistant Secretary for Administration, 

the Deputy Assistant Secretary for 

Policy, the Deputy Assistant Secretary 

for External Affairs, the Deputy 

Assistant Secretary for Early Childhood 

Development, and Staff and Program 

Offices. ACF is organized as follows: 

Office of the Assistant Secretary for 

Children and Families (KA) 

Administration on Children, Youth and 

Families (KB) 

Administration for Native Americans 

(KE) 

Office of Child Support Enforcement 

(KF) 

Office of Community Services (KG) 

Office of Family Assistance (KH) 

Office of Regional Operations (KJ) 

Office of Planning, Research and 

Evaluation (KM) 

Office of Public Affairs (KN) 

Office of the Deputy Assistant Secretary 

for Administration (KP) 

Office of Refugee Resettlement (KR) 

Office of Legislative Affairs and Budget 

(KT) 

Office of Head Start (KU) 

Office of Child Care (KV) 

II. Delete KA.20 Functions, Office of 

the Deputy Assistant Secretary for Early 

Childhood Development, paragraph E, 

in its entirety and replace with the 

following: 

KAH.00 Mission. The Office of the 

Deputy Assistant Secretary for Early 

Childhood Development (ODAS–ECD) 

advises the Secretary, through the 

Assistant Secretary for Children and 

Families, in the formulation of policy 

positions, budget, and implementation 

strategies on matters related to early 

childhood programs and services under 

the purview of ACF. Additionally, ECD 

serves as the representative on behalf of 

the Assistant Secretary to the 

Department and on behalf of the 

Department to other agencies across the 

government on matters involving early 

childhood development. 

KAH.10 Organization. ODAS–ECD is 

headed by the Deputy Assistant 

Secretary who reports directly to the 

Assistant Secretary for Children and 

Families. ODAS–ECD is organized as 

follows: 

Office of the Deputy Assistant Secretary 

for Early Childhood Development 

(KAH) 

Division of Policy and Budget (KAH1) 

Division of Comprehensive Services and 

Training and Technical Assistance 

(KAH2) 

Division of Research, Analysis, and 

Communications (KAH3) 

Division of Interagency and Special 

Initiatives (KAH4) 

KAH.20 Functions. A. Office of the 

Deputy Assistant Secretary (KAH): The 

Office of the Deputy Assistant Secretary 

is responsible for: (1) Providing 

leadership, coordination, planning, and 

oversight of early childhood systems 

across Head Start, child care, and other 

relevant child- and family-serving 

governmental and non-governmental 

organizations at all levels; (2) promoting 

high-quality and accountable early 

childhood programs for all children; (3) 

coordinating the development of policy, 

legislative, regulatory, and budgetary 

proposals across the Office of Child Care 

(OCC) and the Office of Head Start 

(OHS); and (4) conducting outreach and 

maintaining relationships with and 

responding to inquiries from 

governmental and non-governmental 

organizations. 

The Associate Deputy Assistant 

Secretary for Early Childhood 

Development (ADAS) reports to and 

assists the Deputy Assistant Secretary in 

carrying out the responsibilities of ECD 

and serves as a liaison to the Directors 

of OCC and OHS. The ADAS performs 

the duties of the Deputy Assistant 

Secretary when absent. The ADAS also 

supervises all Division Directors 

(KAH1–KAH4). 

B. Division of Policy and Budget 

(KAH1): The Division of Policy and 

Budget is responsible for: (1) Advising 

the Deputy Assistant Secretary and the 

Directors of OCC and OHS on matters 

relating to policy, regulation 

development, legislative issues, and 

budget formulation to better align early 

childhood programs; (2) coordination 

and oversight of policies, regulations, 

program instructions, information 

memoranda, and other policy 

documents governing early childhood 

programs; (3) coordination of strategic 

plans and long-term goals to more 

effectively and efficiently protect and 

promote early childhood development; 

(4) overall budget coordination, 

development, presentation, and 

activities consistent with ACF and HHS 

vision and goals; (5) development of 

cross-cutting policy and strategic 

problem solving in early childhood 

settings; (6) reviewing, analyzing, and 

providing recommendations on 

budgetary and policy impacts of 

congressional or administrative 

proposals. 

C. Division of Comprehensive 

Services and Training and Technical 

Assistance (KAH2): The Division of 

Comprehensive Services and Training 

and Technical Assistance is responsible 

for: (1) Supporting local, state, territory, 

and tribal grantees, and Regional Offices 

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in providing or promoting the 

coordination of high-quality, 

comprehensive, early childhood 

programs that are responsive to and 

supportive of early childhood 

development; and promoting family 

engagement and facilitating linkages to 

health, nutrition, dental, and mental 

health services, as well as promoting 

strong program management and fiscal 

systems, to build a diversified system 

across all early childhood settings that 

promotes school readiness and schoolage success; (2) providing technical 

assistance to local agencies (in 

particular Head Start and Early Head 

Start grantees), states, territories, tribes, 

and Regional Offices concerning the 

administration of early childhood 

programs and school-age care programs 

(in conformance with applicable 

requirements); (3) supporting the 

implementation of training and 

technical assistance strategies to build 

capacity for program leaders, teachers, 

and other staff to implement evidencebased practices designed to increase the 

knowledge, skills, and competencies of 

the early childhood workforce, as well 

as their professional recognition and 

compensation; (4) providing leadership, 

coordination, and oversight of technical 

assistance grants, cooperative 

agreements and contracts, and 

publications to identify and promote 

replication of effective practices with 

children and families; (5) working with 

local, state, territorial, and tribal 

agencies, and Regional Offices to assess 

technical assistance needs and forging 

partnerships with public and private 

organizations to develop tailored 

approaches to address needs; (6) 

providing content expertise and 

leadership to the field in all 

comprehensive service areas, including, 

but not limited to, early childhood 

education; disability services; dual 

language learners; school age services; 

family and community engagement; 

management and fiscal operations; and 

health, wellness, safety and licensing; 

(7) supporting all content areas with a 

focus on relevant and necessary 

professional development; and (8) 

coordinating with the other divisions in 

ECD, OHS, and OCC on content related 

to monitoring, interagency agreements, 

policy, the Web site, and departmental 

responses to departmental inquiries. 

D. Division of Research, Analysis, and 

Communications (KAH3): The Division 

of Research, Analysis, and 

Communications is responsible for: (1) 

Identifying and developing areas for 

research, demonstration, or 

developmental activities designed to 

improve the quality and level of services 

provided to and by early childhood in 

conjunction with the Offices of Child 

Care and Head Start and the Office of 

Planning, Research and Evaluation; (2) 

conducting analyses and special studies 

of early childhood reports and 

documentation, and identifying future 

implications; (3) developing, directing, 

and coordinating communication and 

engagement with internal and external 

stakeholders; and (4) coordinating 

efforts to plan, evaluate, and improve 

external and internal communication 

and messaging in response to or 

anticipation of programmatic, policy, or 

research developments with 

implications affecting the early 

childhood landscape. 

E. Division of Interagency and Special 

Initiatives (KAH4): The Division of 

Interagency and Special Initiatives is 

responsible for: (1) Fostering 

coordination at the federal, regional, 

state, and local levels to develop a 

continuum of comprehensive early 

childhood services, promoting family 

engagement and facilitating linkages to 

health, nutrition, dental, and mental 

health services from birth to age 8, and 

promoting connections and transitions 

with services for expectant families and 

school-age care programs serving 

children up to age 13; (2) formulating 

strategic plans and long-term goals to 

encourage development of this 

continuum of services and innovative 

programming; (3) ensuring coordination 

of policy and budget activities between 

federal agencies and within ACF as 

appropriate; (4) designing, developing, 

and planning with internal and external 

organizations regarding early childhood 

programs; (5) serving as the focal point 

to provide direction, coordination, and 

oversight of special initiatives; (6) 

developing and managing projects, and 

tracking internal and external agency 

initiatives; (7) serving as the liaison 

with other government agencies for 

policy and procedure development, 

coordination, and execution of jointly 

administered programs and initiatives 

involving early childhood, afterschool, 

and summer programs. 

III. Delete Chapter KU, Office of Head 

Start, in its entirety and replace with the 

following: 

KU.00 Mission. The Office of Head 

Start (OHS) has primary responsibility 

for the overall direction, policy and 

budget development and management, 

and oversight of Head Start operations 

authorized under the Head Start Act. 

OHS advises the Deputy Assistant 

Secretary for Early Childhood 

Development on issues regarding the 

Head Start program (including Early 

Head Start). OHS identifies legislative 

and budgetary requirements; identifies 

areas for research, demonstration, and 

developmental activities; presents 

operational planning objectives and 

initiatives relating to Head Start and 

Early Head Start to the Deputy Assistant 

Secretary for Early Childhood 

Development; and oversees the progress 

of approved activities. OHS provides 

leadership and coordination for the 

activities of the Head Start program in 

the ACF Central Office, including the 

Head Start Regional Program Units. 

OHS represents Head Start in interagency activities with other federal and 

non-federal organizations. 

KU.10 Organization. OHS is headed 

by a Director who reports directly to the 

Deputy Assistant Secretary for Early 

Childhood Development. OHS is 

organized as follows: 

Office of the Director (KUA) 

Division of Program Operations (KUB) 

Head Start Regional Program Units 

(KUBDI–XII) 

Division of Planning, Oversight, and 

Policy (KUE) 

Division of Grants (KUF) 

Division of Contracts (KUG) 

Division of Budget Execution (KUH) 

KU.20 Functions. A. Office of the 

Director (KUA): The Office of the 

Director (OD) serves as the principal 

advisor to the Deputy Assistant 

Secretary for Early Childhood 

Development on the administration of 

discretionary grant programs providing 

Head Start and Early Head Start 

services. The OD has overall 

responsibility for policy and budget 

development specific to Head Start, as 

well as for the management and 

oversight of the Head Start program and 

supervision of OHS Division Directors. 

The OD is responsible for: (1) Providing 

public information services by 

responding to inquiries from the public 

and private sectors; (2) serving as the 

central point for operational and longrange planning needs for OHS; (3) 

conducting outreach and maintaining 

relationships with Department officials; 

other federal departments; state, tribal, 

and local officials; and private 

organizations and individuals; (4) 

coordinating and planning Head Start 

and Early Head Start activities to 

maximize program effectiveness; and (5) 

managing large-scale or high-profile 

activities involving multiple OHS areas 

of responsibility. The Deputy Director 

reports to and assists the Director in 

carrying out the responsibilities of OHS 

and performs the duties of the Director 

when absent. 

The Administration Team is 

responsible for providing administrative 

and human resource support to OHS in: 

(1) Planning and coordinating the 

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provision of new employee orientation, 

staff development, and training; (2) 

personnel administration, including 

position descriptions, job analysis, 

recruitment and selection, employee 

and labor relations, work force analysis, 

and PMAP coordination; (3) 

timekeeping, oversight of travel, 

transhare, and credit card accounts/

profiles; (4) managing controlled space, 

facilities, and equipment; and (5) liaison 

for work/life balance, staff wellness, and 

employee recognition. 

B. Division of Program Operations 

(KUB): The Division of Program 

Operations is responsible for: (1) 

Advising the Director on all strategic 

and operational activities related to the 

design and implementation of Head 

Start and Early Head Start programs in 

the 12 regions; (2) providing oversight, 

direction, and guidance to the Head 

Start Regional Program Units; (3) 

providing ongoing management of 

national Head Start program operations 

inclusive of grantee-level Designation 

Renewal System determinations, 

funding, ongoing oversight and 

monitoring, and training and technical 

assistance; (4) managing Head Start 

program-level data systems; and (5) 

serving as OHS liaison to the Offices of 

Grants Management and Information 

Systems. 

C. Division of Planning, Oversight, 

and Policy (KUE): The Division of 

Planning, Oversight, and Policy is 

responsible for: (1) Overseeing the 

development and issuance of policy, 

regulations, program instructions, 

information memoranda, and other 

policy documents governing Head Start 

and Early Head Start; and legislative 

issues and budget formulation in 

coordination with ODAS–ECD and 

consistent with ACF early childhood 

priorities; (2) overseeing all major 

planning and implementation activities 

to determine Head Start and Early Head 

Start programs’ compliance, quality, and 

performance with all applicable 

requirements and regulations; (3) 

conducting data analyses on monitoring 

outcomes to inform training and 

technical assistance efforts, and policy 

guidance and development; (4) serving 

as the liaison to the Office of Inspector 

General (OIG) for targeted OIG audits; 

(5) managing the OHS Complaint Line; 

and (6) assisting in the preparation of 

Congressional reports and briefing 

materials for hearings and testimony. 

D. Division of Grants (KUF): The 

Division of Grants is responsible for: (1) 

Overseeing matters related to 

competitive discretionary and 

cooperative agreement funding 

opportunities; (2) managing 

discretionary grant competition, 

including Designation Renewal, 

paneling, and awarding; (3) serving as 

the liaison to the Office of 

Administration, Divisions of Grants 

Management, and Division of Grants 

Policy for all matters related to 

competitive funding; and (4) oversight 

and management of interim grantees. 

E. Division of Contracts (KUG): The 

Division of Contracts is responsible for: 

(1) Providing ongoing oversight of 

national Head Start and Early Head Start 

contracts; (2) providing expert technical 

assistance and guidance to OHS contract 

officer representatives on all matters 

related to procurement and acquisition; 

(3) providing ongoing monitoring of all 

OHS contracts ensuring internal 

controls are adequate; and (4) serving as 

liaison to the Contracts Offices. 

F. Division of Budget Execution 

(KUH): The Division of Budget 

Execution is responsible for: (1) 

Identifying budgetary needs and 

working with divisions within ECD to 

ensure adequate funding; (2) providing 

oversight, execution, and ongoing 

management of all federal Head Start 

program and administrative funds; (3) 

providing guidance and advice on the 

execution of the Head Start and Early 

Head Start budgets; (4) establishing and 

implementing procedures for all phases 

of budget execution; (5) completing 

detailed reviews and analyses of 

grantees financial operating plans 

ensuring budgetary resources are used 

in a manner consistent with the OHS 

mission and are not over spent or 

obligated beyond appropriate limits; (6) 

apportioning funds appropriated by 

Congress; (7) preparing all required 

financial reports necessary and entry of 

all past-year data requirements; and (8) 

preparation of historical budget-related 

data, congressional inquiries, and data 

for budget formulation and hearings. 

G. Head Start Regional Program Units 

(KUBDI–XII): The Head Start Regional 

Program Units are each headed by a 

Regional Program Manager (RPM) who 

report to the Director of the Division of 

Program Operations. Head Start 

Regional Program Units are responsible 

for: (1) Administering funding, ongoing 

oversight and monitoring, and training 

and technical assistance to the grantee 

agencies that provide services to Head 

Start and Early Head Start children and 

families; (2) providing ongoing 

management of Regional Head Start 

program operations, including State 

Collaboration grants; (3) serving as OHS 

Liaison within the Region to the 

Regional Office of Child Care and the 

Office of Grants Management; and (4) 

advising the Director on Regional issues 

impacting the Head Start program. 

Regions I through X are located in the 

ACF geographical regions. Region XI, 

American Indian/Alaska Native Head 

Start, located at the OHS central office, 

administers grants for Indian Head Start 

grantees. Region XII, Migrant and 

Seasonal Head Start, located at the OHS 

central office, administers grants for 

agencies that serve the children and 

families of migrant and seasonal farm 

workers. 

IV. Delete Chapter KV, Office of Child 

Care, in its entirety and replace with the 

following: 

KV.00 Mission. The Office of Child 

Care (OCC) advises the Deputy Assistant 

Secretary for Early Childhood 

Development on matters relating to 

services provided in child care centers, 

homes, and school-age care programs, 

focusing on the twin goals of supporting 

family success and child development 

by improving access to high-quality 

child care to promote healthy 

development, school readiness, and 

school success for children. OCC 

identifies legislative and budgetary 

requirements; identifies areas for 

research, demonstration, and 

developmental activities; presents 

operational planning objectives and 

initiatives relating to child care to the 

Deputy Assistant Secretary for Early 

Childhood Development; and oversees 

the progress of approved activities. OCC 

has primary responsibility for the 

overall direction, policy and budget 

development and management, and 

oversight of Child Care program 

operations authorized under the Child 

Care and Development Block Grant 

(CCDBG) and section 418 of the Social 

Security Act. OCC supports state, tribal, 

and territorial grantees’ efforts to 

provide financial assistance to lowincome families so children can have 

access to high-quality child care so 

parents can engage in work, education, 

and other activities to support their 

families and be successful. OCC 

develops comprehensive, cross-sector 

systems of quality improvement so 

Child Care programs can achieve higher 

levels of quality training and education 

for the child care work force and 

programs. OCC provides leadership and 

coordination for child care issues within 

ACF, HHS, and with relevant federal, 

state, local, and tribal governmental and 

non-governmental organizations. 

KV.10 Organization. OCC is headed 

by a Director who reports to the Deputy 

Assistant Secretary for Early Childhood 

Development. OCC is organized as 

follows: 

Office of the Director (KVA) 

Division of Program Operations (KVA2) 

Division of Oversight and 

Accountability (KVA3) 

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Division of Planning, Data, and Policy 

(KVA4) 

Child Care Regional Program Units 

(KVADI–X) 

KV.20 Functions. A. Office of the 

Director (KVA): The Office of the 

Director (OD) serves as the principal 

advisor to the Deputy Assistant 

Secretary for Early Childhood 

Development on the administration of 

Child Care programs. The OD is 

responsible for the overall management, 

oversight, and policy and budget 

development specific to the Child Care 

program, and for supervision of the OCC 

Division Directors. The OD is also 

responsible for: (1) Providing public 

information services by responding to 

inquiries from the public and private 

sectors; (2) serving as the central point 

for operational and long-range planning 

needs for OCC; (3) conducting outreach 

and maintaining relationships with 

Department officials; other federal 

departments; state, tribal, and local 

officials; and private organizations and 

individuals; (4) coordinating and 

planning Child Care activities to 

maximize program effectiveness; and (5) 

managing large-scale or high-profile 

activities involving multiple OCC areas 

of responsibility. The Deputy Director 

assists the Director in carrying out the 

duties of the Office of the Director (OD) 

and performs the duties of the Director 

when absent. 

Within the Office of the Director, 

Management Operation Staff is 

responsible for: (1) Managing the 

execution of the budgets for OCCoperated programs and for federal 

administration of the OCC program; (2) 

serving as the central control point for 

operational and long-range planning of 

the needs of OCC; (3) planning for and 

coordinating the provision of staff 

development and training; (4) providing 

support for OCC’s personnel 

administration, including staffing, 

employee and labor relations, 

performance management, and 

employee recognition; (5) managing 

procurement planning and providing 

technical assistance regarding 

procurement; (6) managing OCCcontrolled space, facilities, and 

equipment, including providing for 

health and safety; (7) planning for, 

acquiring, distributing, and controlling 

OCC supplies; (8) functioning as 

Executive Secretariat for OCC, including 

managing correspondence, 

correspondence systems, electronic mail 

requests, and mail and messenger 

services; (9) overseeing processes 

related to approval and payment of 

travel; and (10) maintaining fax, 

computer, and computer peripheral 

equipment. 

B. Division of Program Operations 

(KVA2): The Division of Program 

Operations is responsible for: (1) 

Developing and managing the process to 

solicit, collect, and document Child 

Care Development Fund (CCDF) plans 

of states, territories, and tribes to 

comply with federal CCDBG law and 

regulation on a triennial basis; (2) 

regional liaison activities, including 

communicating on a regular basis with 

regional Program Unit staff; oversight of 

the review and approval process for the 

Triennial CCDF Plans of state, 

territories, and tribes; and responding to 

questions on policy and other issues by 

consulting or referring to other staff; (3) 

collecting and maintaining information 

related to grantee program plans and 

benchmarks for achieving full 

implementation and compliance with 

federal law and regulation; (4) 

anticipating, identifying, and providing 

technical assistance for grantees to 

support the CCDF Program; (5) 

analyzing and describing grantee CCDF 

Plans, trends, policy and program 

challenges, and opportunities of major 

significance to inform the Director, 

other ACF and HHS officials, grantees, 

and the general public; (6) tracking and 

supporting special initiatives; (7) 

establishing partnerships with public 

and private entities to improve access to 

quality child care; (8) coordinating 

program activities with other 

government and non-governmental 

agencies; and (9) managing and 

overseeing cooperative ventures with 

other entities. 

C. Division of Oversight and 

Accountability (KVA3): The Division of 

Oversight and Accountability is 

responsible for: (1) Monitoring grantees 

for compliance in the implementation of 

CCDF plans, and for programmatic and 

fiscal compliance with policies, 

regulations, and other guidance 

authorized under the CCDBG and 

section 418 of the Social Security Act; 

(2) planning, directing, and coordinating 

a comprehensive fiscal monitoring 

program encompassing budget planning 

and execution, automated financial 

systems, fiscal accounting, internal and 

external audit reporting requirements, 

improper payment reporting 

methodology, and corrective actions; (3) 

coordinating and targeting on-site visits 

to grantees to provide performance 

oversight and promote continuous 

program improvement; (4) overseeing 

and processing grantee reports to ensure 

grantee accountability; (5) serving as the 

liaison to the Office of Inspector General 

for OIG audits and Government 

Accountability Office (GAO) studies; 

and (6) identifying and developing 

ongoing quality improvement strategies 

to address challenges grantees have in 

the successful implementation of their 

programs, which includes coordinating 

with the Regional Program Units and 

the Division of Training and Technical 

Assistance within ODAS–ECD. 

D. Division of Planning, Data, and 

Policy (KVA4): The Division of 

Planning, Data, and Policy is 

responsible for: (1) Advising the Office 

of the Director and overseeing 

development and issuance of policies, 

regulations, program instructions, 

information memoranda, and other 

policy documents; legislative issues; 

and budget formulation governing the 

CCDF program in coordination with 

ODAS–ECD and consistent with ACF 

early childhood priorities; (2) analyzing 

and describing grantee data trends to 

inform policy guidance and 

development, the Director, other ACF 

and HHS officials, grantees, and the 

general public; (3) overseeing 

procedures for and collection of state, 

territory, and tribal grantee 

administrative and expenditure data 

and reports as required by the CCDBG; 

(4) reviewing data to determine 

accuracy in reporting and to work with 

grantees to identify challenges to 

accurate and timely data reporting; (5) 

developing and tracking performance 

measures to ensure the program meets 

established goals; (6) conducting data 

analysis to inform training and technical 

assistance efforts and policy guidance 

and development; and (7) assisting in 

the preparation of Congressional reports 

and briefing materials for hearings and 

testimony. 

E. Child Care Regional Program Units 

(KVADI–X): The OCC Regional Program 

Units are headed by an OCC Regional 

Program Manager who reports to the 

Deputy Director, OCC. The Regional 

Program Manager, through subordinate 

regional staff and in collaboration with 

program components, is responsible for: 

(1) Providing program and technical 

administration of OCC block and 

discretionary programs; (2) collaborating 

with the OCC Central Office, states, and 

other grantees on all significant policy 

matters; (3) providing technical 

assistance to entities responsible for 

administering OCC programs to resolve 

identified problems; (4) ensuring that 

appropriate procedures and practices 

are adopted; (5) working with 

appropriate state, tribal, and local 

officials to develop and implement 

outcome-based performance goals that 

further the OCC mission of supporting 

children and families by increasing 

access to affordable, high-quality child 

care; and (6) monitoring the programs to 

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Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 7351 

ensure their efficiency and 

effectiveness, and ensuring that these 

entities conform to federal laws, 

regulations, policies, and procedures 

governing the programs. 

V. Continuation of Policy. Except as 

inconsistent with this reorganization, all 

statements of policy and interpretations 

with respect to organizational 

components affected by this notice 

within ACF, heretofore issued and in 

effect on this date of this reorganization 

are continued in full force and effect. 

VI. Delegation of Authority. All 

delegations and re-delegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them, or 

their successors, pending further redelegations, provided they are 

consistent with this reorganization. 

VII. Funds, Personnel, and 

Equipment. Transfer of organizations 

and functions affected by this 

reorganization shall be accompanied in 

each instance by direct and support 

funds, positions, personnel, records, 

equipment, supplies, and other 

resources. 

FOR FURTHER INFORMATION CONTACT: 

Linda K. Smith, Office of the Deputy 

Assistant Secretary for Early Childhood 

Development, 901 D Street SW., 

Washington, DC 20447, (202) 401–9200. 

This reorganization will be effective 

upon date of signature. 

Dated: February 5, 2016. 

Sylvia M. Burwell, 

Secretary. 

[FR Doc. 2016–02784 Filed 2–10–16; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0001] 

Pharmacy Compounding Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

forthcoming meeting of a public 

advisory committee of the Food and 

Drug Administration (FDA). The 

meeting will be open to the public. 

Name of Committee: Pharmacy 

Compounding Advisory Committee 

(PCAC). 

General Function of the Committee: 

To provide advice on scientific, 

technical, and medical issues 

concerning drug compounding under 

sections 503A and 503B (21 U.S.C. 353A 

and 353B) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), and, as 

required, any other product for which 

FDA has regulatory responsibility, and 

make appropriate recommendations to 

the Commissioner of Food and Drugs. 

Date and Time: The meeting will be 

held on March 8, 2016, from 8:30 a.m. 

to 4:30 p.m., and on March 9, 2016, 

from 8:30 a.m. to 1 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Hong, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: PCAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://www.fda.

gov/AdvisoryCommittees/default.htm 

and scroll down to the appropriate 

advisory committee meeting link, or call 

the advisory committee information line 

to learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Background: Section 503A of the 

FD&C Act describes the conditions that 

must be satisfied for human drug 

products compounded by a licensed 

pharmacist or licensed physician to be 

exempt from the following three 

sections of the FD&C Act: (1) Section 

501(a)(2)(B) (concerning current good 

manufacturing practice (CGMP)); (2) 

section 502(f)(1) (concerning the 

labeling of drugs with adequate 

directions for use); and (3) section 505 

(21 U.S.C. 355) (concerning the approval 

of human drug products under new 

drug applications (NDAs) or abbreviated 

new drug applications (ANDAs)). 

The Drug Quality and Security Act 

adds a new section, 503B, to the FD&C 

Act that creates a new category of 

‘‘outsourcing facilities.’’ Outsourcing 

facilities, as defined in section 503B of 

the FD&C Act, are facilities that meet 

certain conditions described in section 

503B, including registration with FDA 

as an outsourcing facility. If these 

conditions are satisfied, a drug product 

compounded for human use by or under 

the direct supervision of a licensed 

pharmacist in an outsourcing facility is 

exempt from three sections of the FD&C 

Act: (1) Section 502(f)(1), concerning the 

labeling of drugs with adequate 

directions for use; (2) section 505, 

concerning the approval of human drug 

products under NDAs or ANDAs; and 

(3) section 582, concerning the track and 

trace requirements in the Drug Supply 

Chain Security Act (Pub. L. 113–53). 

Outsourcing facilities are not exempt 

from CGMP requirements in section 

501(a)(2)(B) of the FD&C Act. 

One of the conditions that must be 

satisfied to qualify for the exemptions 

under section 503A of the FD&C Act is 

that a bulk drug substance (active 

pharmaceutical ingredient) used in a 

compounded drug product must meet 

one of the following criteria: (1) 

Complies with the standards of an 

applicable United States Pharmacopoeia 

(USP) or National Formulary 

monograph, if a monograph exists, and 

the USP chapter on pharmacy 

compounding; (2) if an applicable 

monograph does not exist, is a 

component of a drug approved by the 

Secretary of Health and Human Services 

(the Secretary); or (3) if such a 

monograph does not exist and the drug 

substance is not a component of a drug 

approved by the Secretary, appears on a 

list (the ‘‘section 503A bulk drug 

substances list’’) developed by the 

Secretary through regulations issued by 

the Secretary (see section 

503A(b)(1)(A)(i) of the FD&C Act). 

Another condition that must be 

satisfied to qualify for the exemptions 

under section 503A of the FD&C Act is 

that the compounded drug product is 

not a drug product identified by the 

Secretary by regulation as a drug 

product that presents demonstrable 

difficulties for compounding that 

reasonably demonstrate an adverse 

effect on the safety or effectiveness of 

that drug product (see section 

503A(b)(3)(A) of the FD&C Act). 

A condition that must be satisfied to 

qualify for the exemptions in section 

503B of the FD&C Act is that the 

compounded drug is not identified 

(directly or as part of a category of 

drugs) on a list published by the 

Secretary, by regulation after consulting 

with the Pharmacy Compounding 

Advisory Committee, of drugs or 

categories of drugs that present 

demonstrable difficulties for 

compounding that are reasonably likely 

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