81280 Federal Register / Vol. 75, No. 247 / Monday, December 27, 2010 / Notices 

contingency fee basis and overpayments 

the MAO recoups as a result of the RAC 

activities would be retained by the 

MAO. In approaching this work, the 

RAC contractor would consider the use 

of complex and automated review of 

claims. 

• Approaches to implementing the 

following special rules provisions of 

section 6411(b) of ACA: 

++ We want to utilize RACs to ensure 

that each Part C and Part D plan has 

anti-fraud plans in place and to review 

the effectiveness of those anti-fraud 

plans. In accordance with section 

1893(h) of the ACA, the RACs for the 

Part C and Part D programs would be 

paid on a contingency basis, as in the 

Medicare FFS program. We are 

interested in the industry’s views on 

how to pay RACs on a contingency basis 

for reviewing anti-fraud plans in the 

Part C and Part D programs given there 

are no recoveries or overpayments 

resulting from a review of such plans. 

Should this contingency basis differ 

from how RACs are paid for reviewing 

Medicare FFS claims? If so, how? 

++ The statute requires that we use 

RACs to examine claims for reinsurance 

payments to determine whether Part D 

plans submitting such claims incurred 

costs in excess of the allowable 

reinsurance costs permitted under the 

statute. Under the Part D statute, Part D 

plans legitimately incur costs in excess 

of allowable reinsurance costs during 

the catastrophic phase of the benefit. In 

the catastrophic phase of the defined 

standard benefit, 80 percent of the 

negotiated price is paid by Federal 

reinsurance, 15 percent is the 

responsibility of the sponsor (and is 

incorporated into their bid for the direct 

subsidy) and 5 percent is the 

responsibility of the beneficiary. 

Prospective reinsurance payments to 

plans are based on plans’ estimates of 

reinsurance costs and, as required by 

statute, we reconcile these prospective 

reinsurance payments for sponsors with 

actual reinsurance costs. Given this 

annual reconciliation process, requiring 

RACs to review the accuracy of the 

prospective reinsurance payments is 

less likely to result in recovery of 

overpayments. 

However, we are considering having 

RACs examine the accuracy and 

completeness of sponsors’ reporting of 

Direct and Indirect Remuneration (DIR). 

The DIR information reported by plans 

includes rebates paid by pharmaceutical 

manufacturers, as well as other 

remuneration received by the plan that 

has the effect of reducing their drug 

costs, and is used as a factor in our 

payment calculations to Part D plans. 

Under-reporting of DIR by plans would 

overstate plans’ drug costs, including in 

the catastrophic phase of the benefit, 

and would result in an overpayment to 

the plan. We are interested in receiving 

comments on how RACs could be used 

to review the accuracy and 

completeness of DIR information 

provided to us by plans. 

++ The statute also requires that we 

use RACs to review estimates submitted 

by Part D plans with respect to 

enrollment of high cost beneficiaries. A 

Part D sponsor’s estimates for the 

enrollment of high cost beneficiaries 

may impact the reinsurance estimates in 

their Part D bids and thus, the 

prospective reinsurance subsidy 

payments they receive from us. 

However, given the structure of the Part 

D program that requires us to reconcile 

reinsurance subsidy payments against a 

Part D sponsor’s actual costs, requiring 

RACs to undertake this activity is less 

likely to result in recovery of any 

reinsurance overpayments. However, as 

noted previously, we are interested in 

receiving comments on how RACs 

might be used to identify overpayments 

and underpayments associated with DIR 

reporting. 

++ We are interested in learning about 

successful overpayment recoupment 

models in managed care that may 

already exist in the commercial sector 

and to what extent these models are 

applicable to Part C. Successfully 

integrating RACs into Part C presents a 

particular challenge because of how Part 

C payments are paid. Under the 

statutory payment formula, plans are 

paid on a capitated basis. Therefore, the 

plan, not the government, is at direct 

risk for any overpayments and 

underpayments made to its providers. 

We are interested in learning whether 

and how other purchasers have 

identified overpayments and 

underpayments made by capitated plans 

and to what extent savings were shared 

between the plan and the purchaser. 

• Any additional information 

concerning the development of a RAC 

program in Medicare Part C and Part D 

and how we can establish the required 

program elements to protect the 

Medicare Parts C and D programs from 

fraud, waste, and abuse. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: December 8, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–32498 Filed 12–23–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Head Start; Statement of 

Organization, Functions, and 

Delegations of Authority 

AGENCY: Administration for Children 

and Families, HHS. 

ACTION: Notice. 

SUMMARY: Statement of Organizations, 

Functions, and Delegations of 

Authority. The Administration for 

Children and Families (ACF) has 

reorganized the Office of Head Start 

(OHS). This reorganization creates the 

Grants and Contracts Division and the 

State Initiatives Division. It renames the 

Educational Development and 

Partnership Division, titling it the 

Education and Comprehensive Services 

Division. It also renames the Immediate 

Office of Head Start, the Office of the 

Director. Additionally, it renames the 

Policy and Budget Division, the Policy 

and Planning Division. 

FOR FURTHER INFORMATION CONTACT: 

Yvette Sanchez-Fuentes, Office of the 

Director, Office of Head Start, 1250 

Maryland Avenue, SW., Washington, 

DC 20024, 202–205–8573. 

This notice amends Part K of the 

Statement of Organization, Functions, 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Administration for 

Children and Families (ACF) as follows: 

Chapter KU, Office of Head Start (OHS), 

as last amended 71 FR 59117–59123, 

October 6, 2006. 

I. Under Chapter, KU, Office of Head 

Start, delete KU in its entirety and 

replace with the following: 

KU.00 MISSION. The Office of Head 

Start (OHS) advises the Assistant 

Secretary for Children and Families on 

issues regarding the Head Start program 

(including Early Head Start). OHS 

develops legislative and budgetary 

proposals; identifies areas for research, 

demonstration and developmental 

activities; presents operational planning 

objectives and initiatives relating to 

Head Start and Early Head Start to the 

Assistant Secretary; and oversees the 

progress of approved activities. It 

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 inter-agency activities with 

other Federal and non-Federal 

organizations. 

KU.10 ORGANIZATION. OHS is 

headed by a director who reports 


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Federal Register / Vol. 75, No. 247 / Monday, December 27, 2010 / Notices 81281 

directly to the Assistant Secretary for 

Children and Families. OHS is 

organized as follows: 

Office of the Director (KUA) 

Program Operations Division (KUB) 

Head Start Regional Program Units 

(KUBDI–XII) 

Education and Comprehensive Services 

Division (KUC) 

Quality Assurance Division (KUE) 

Policy and Planning Division (KUF) 

Grants and Contracts Division (KUG) 

State Initiatives Division (KUH) 

KU.20 FUNCTIONS. A. Office of the 

Director (KUA): The Office of the 

Director (OD) serves as the principal 

advisor to the Assistant Secretary for 

Children and Families, the Secretary, 

and other officials of the Department on 

the administration of discretionary grant 

programs providing Head Start Services. 

The Director provides the direction for 

OHS based on ACF’s and HHS’ goals 

and objectives. 

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 Deputy Director supervises all six 

Division Directors in addition to the 

Budget, Administrative, and 

Information Systems Teams. The 

divisions are as follows: Program 

Operations Division, Education and 

Comprehensive Services Division, 

Quality Assurance Division, Policy and 

Planning Division, Grants and Contracts 

Division, and State Initiatives Division. 

The Administrative Team provides 

support to OHS, including: (a) Serving 

as the focal point for operational and 

long-range planning; (b) functioning as 

Executive Secretariat for OHS, including 

managing correspondence, 

correspondence systems, and electronic 

mail requests; (c) providing 

management and administrative 

services and advice, by coordinating 

human resources activities, and (d) as 

appropriate, developing policy and 

procedures relating to these activities. 

The Budget Team (a) Provides 

leadership in the development of the 

budget while ensuring consistency with 

ACF’s and the Department’s vision and 

goals, (b) is responsible for budget 

development and execution, and (c) 

serves as the primary contact for ACF on 

all budget development and execution 

activities related to Head Start. The 

Information Systems Team (IST) 

provides support to OHS in providing 

centralized information systems policy, 

procedures, standards, and guidelines. 

IST also provides support through: (a) 

The oversight of information resources 

management (IRM) systems, including 

the Early Childhood Learning and 

Knowledge Center and Head Start 

Enterprise System; (b) directing and 

coordinating OHS’ Privacy Act 

responsibilities; (c) directing and 

maintaining OHS electronic records and 

forms management programs; (d) 

developing long-range IRM plans; (e) 

developing policies, procurement plans, 

and budgets for OHS information 

systems; and (f) serving as the 

information services liaison to ACF and 

other agencies to coordinate 

e-government strategies and policies. 

B. Program Operations Division 

(KUB): The Program Operations 

Division (POD) advises the OHS 

Director on all strategic and operational 

activities related to implementation of 

the agency’s programs in the 12 regions. 

POD is responsible for the Head Start 

regional programs administered by the 

Head Start Regional Program Units 

which include Region XI, the American 

Indian and Alaska Native Head Start, 

and Region XII, the Migrant and 

Seasonal Head Start. 

—Head Start Regional Program Units 

(KUBDI–XII): The Head Start Regional 

Program Units are each headed by a 

Regional Program Manager (RPM) who 

reports to the Director of the Program 

Operations Division. The RPM, through 

subordinate regional staff, in 

collaboration with program 

components, is responsible for: (1) 

Providing program and technical 

administration of ACF discretionary 

programs related OHS; (2) collaborating 

with OHS States Collaboration Projects 

on all significant policy matters; (3) 

providing technical assistance to 

entities responsible for administering 

OHS programs to resolve identified 

problems; (4) ensuring that appropriate 

procedures and practices are adopted; 

(5) working with appropriate State, 

local, and tribal officials to develop and 

implement outcome-based performance 

measures; and (6) monitoring the 

programs to ensure their efficiency and 

effectiveness, and ensuring that these 

entities conform to Federal laws, 

regulations, policies, and procedures 

governing the programs. The Head Start 

Regional Program Unit serves agencies 

that provide services to the children and 

families throughout the United States. 

The Regional Program Unit (a) guides 

the day-to-day management of Head 

Start programs in its jurisdictions; (b) 

provides technical assistance, resources, 

and information to the various entities 

responsible for administering these 

programs; (c) designates and provides 

oversight for interim grantees; and (d) 

represents Head Start to state, county, 

city, and Tribal governments; grantees; 

and public and private organizations. 

Regions I through X are located in the 

ACF geographical regions. Region XI, 

American Indian and Alaskan Native 

Head Start, serves agencies that provide 

services to the children and families of 

American Indian and Alaskan Natives. 

Migrant and Seasonal Head Start is 

represented by Region XII and serves 

agencies that provide services to the 

children and families of migrant and 

seasonal workers. Regions XI and XII are 

located in the OHS central office. 

C. Education and Comprehensive 

Services Division (KUC): The Education 

and Comprehensive Services Division 

(ECSD) develops and coordinates the 

content and direction of Head Start 

program components and provides 

leadership to improve classroom 

practice, family engagement and 

involvement, health and disabilities 

services and cultural and linguistic 

responsiveness. The ECSD (1) 

recommends and establishes policy in 

the content areas; (2) recommends 

strategies for achieving quality services; 

(3) develops regulation, guidance, and 

other policy materials aimed at 

improving grantee performance in the 

content areas; (4) develops areas for 

research and demonstration activities to 

improve the quality and levels of 

services provided to Head Start 

children; (5) manages discretionary 

projects; and (6) develops training and 

technical assistance strategies to 

improve Head Start programs’ 

performance in specific component 

areas which include integrated content; 

health, nutrition, dental, and mental 

health; parent, family, and community 

engagement; and quality teaching and 

learning. 

D. Quality Assurance Division (KUE): 

The Quality Assurance Division (QAD) 

(1) oversees all major planning and 

implementation activities to determine 

Head Start and Early Head Start 

programs’ compliance with all 

applicable requirements and 

regulations; (2) conducts data analyses 

on monitoring outcomes to inform 

training and technical assistance efforts 

and policy and guidance development; 

(3) serves as the liaison to the Office of 

Inspector General (OIG) for targeted 

OIG’s audits; (4) oversees special agency 

initiatives such as the erroneous 

payment study; and (5) manages the 

OHS Complaint Line. 

E. Policy and Planning Division 

(KUF): The Policy and Planning 

Division (PPD) provides support and 

guidance in all matters related to 

defining and setting policy for the OHS 

that will affect local Head Start 

programs and the early childhood 

community at-large. The Division will 

strengthen guidance and vision to the 


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81282 Federal Register / Vol. 75, No. 247 / Monday, December 27, 2010 / Notices 

early childhood community, formulate 

the OHS strategic plans and long-term 

goals, provide guidance and support 

with budget planning, oversee 

development of regulations and other 

policy issuances, and serve as liaison 

with ACF and HHS legislative offices on 

all Congressional matters relating to 

Head Start. 

F. Grants and Contracts Division 

(KUG): The Grants and Contracts 

Division (GCD) (1) Oversees matters 

related to competitive funding 

opportunities; (2) manages competition, 

paneling, and selection of national 

contracts and Head Start and Early Head 

Start replacement grantees; (3) provides 

ongoing fiscal oversight of national 

contracts; (4) serves as the lead for the 

OHS Program Management and Fiscal 

Operations Center; and (5) serves as the 

liaison to the Office of Administration, 

Divisions of Grants Management and 

Division of Grants Policy. 

G. State Initiatives Division (KUH): 

The State Initiatives Division (SID) leads 

and consolidates collaboration efforts to 

new and expanding Head Start 

programs. The Division will promote 

collaborations with state pre-k 

programs, local child care providers and 

other national and state early childhood 

efforts to ensure the sustainability of 

strong collaborations. The Division 

serves as the locus for ensuring that 

mandates in the Head Start Act 

regarding collaboration are 

implemented as well as coordination 

with the U.S. Department of Education 

and state early childhood entities. The 

Division will focus on State Advisory 

Councils, Centers of Excellence, State 

Collaboration Offices, and the Training 

and Technical Assistance System. 

II. 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. 

III. Delegation of Authority. All 

delegations and redelegations 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. 

IV. 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. 

This reorganization will be effective 

upon date of signature. 

Dated: December 16, 2010. 

David A. Hansell, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2010–32462 Filed 12–23–10; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Circulatory System Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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: Circulatory 

System Devices Panel of the Medical 

Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on January 25 and 26, 2011, from 

8 a.m. to 6 p.m. 

Location: Holiday Inn, Main 

Ballroom, Two Montgomery Village 

Ave., Gaithersburg, MD. Information 

regarding special accommodations due 

to a disability, visitor parking and 

transportation may be accessed at: 

http://www.fda.gov/Advisory

Committees/default.htm; under the 

heading ‘‘Resources for You,’’ click on 

‘‘White Oak Conference Center Parking 

and Transportation Information for FDA 

Advisory Committee Meetings.’’ Please 

note that visitors to the White Oak 

Campus must enter through Building 1. 

Contact Person: James Swink, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512625. Please call the 

Information Line for up-to-date 

information on this meeting. 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 and call the 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On January 25, 2011, the 

committee will discuss and make 

recommendations regarding regulatory 

classification of Automated External 

Defibrillators to either reconfirm to class 

III (subject to premarket approval 

application (PMA)) or reclassify to class 

II (subject to premarket notification 

(510(k))), as directed by section 515(i) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C 360e(i)). 

On January 26, 2011, the committee 

will discuss, make recommendations 

and vote on information related to the 

PMA supplement for the RX Acculink 

Carotid Stent System, sponsored by 

Abbott Vascular. The RX Acculink is 

indicated for treatment of patients at 

high and standard risk for adverse 

events from carotid endarterectomy who 

require carotid revascularization and 

meet the criteria outlined as follows: 

1. Patients with neurological 

symptoms and >50 percent stenosis of 

the common or internal carotid artery or 

patients without neurological symptoms 

and >80 percent (high risk) or >70 

percent (standard risk) stenosis of the 

common or internal carotid artery and 

2. Patients must have a reference 

vessel diameter within the range of 4.0 

and 9.0 mm at the target lesion. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/default.

htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before January 18, 2011. 

Oral presentations from the public will 

be scheduled for 1 hour at 

approximately 1 p.m., immediately 

following lunch on both days. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 


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