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Federal Register / Vol. 70, No.

249 / Thursday, December 29, 2005 / Notices 77159

Miami, FL 33126, Officers: Rossin Washington, DC 20503, and a copy to • Section F.10. (Organization) reads
V. Garcia, Vice President the Regulatory Secretariat (VIR), General as follows:
(Qualifying Individual), Manuel Services Administration, Room 4035, 1. Office of External Affairs (FAC)
Garcia, President. 1800 F Street, NW., Washington, DC 2. Center for Beneficiary Choices (FAE)
Dated: December 23, 2005. 20405. Please cite OMB Control No. 3. Office of Legislation (FAF)
Bryant L. VanBrakle,
3090–XXXX, General Services 4. Center for Medicare Management
Administration (GSA) Child Care (FAH)
Secretary.
Specialist Feedback Form, in all 5. Office of Equal Opportunity and Civil
[FR Doc. E5–8009 Filed 12–28–05; 8:45 am] correspondence. Rights (FAJ)
BILLING CODE 6730–01–P
SUPPLEMENTARY INFORMATION: 6. Office of Research, Development, and
Information (FAK)
A. Purpose 7. Office of Clinical Standards and
GENERAL SERVICES Quality (FAM)
This information will be used to
ADMINISTRATION 8. Office of the Actuary (FAN)
assess consumer satisfaction with
[OMB Control No. 3090–XXXX] services delivered by staff from the 9. Center for Medicaid and State
Office of Child Care services. Operations (FAS)
National Capital Region (NCR), Office 10. Office of the Boston Regional
of Childcare Services; Information B. Annual Reporting Burden Administrator (FAU1)
Collection; General Services Respondents: 144. 11. Office of the New York Regional
Administration (GSA) Child Care Responses Per Respondent: 1. Administrator (FAU2)
Specialist Feedback Form Hours Per Response: .083 (5 minutes). 12. Office of the Philadelphia Regional
Total Burden Hours: 12. Administrator (FAU3)
AGENCY: NCR Office of Childcare 13. Office of the Atlanta Regional
Obtaining Copies of Proposals:
Services, Public Buildings Service Administrator (FAV4)
Requesters may obtain a copy of the
(PBS), GSA. 14. Office of the Chicago Regional
information collection documents from
ACTION: Notice of request for comments the General Services Administration, Administrator (FAW5)
regarding a request for a new OMB Regulatory Secretariat (VIR), 1800 F 15. Office of the Dallas Regional
clearance. Street, NW., Room 4035, Washington, Administrator (FAV6)
DC 20405, telephone (202) 208–7312. 16. Office of the Kansas City Regional
SUMMARY: Under the provisions of the
Please cite OMB Control No. 3090– Administrator (FAW7)
Paperwork Reduction Act of 1995 (44
XXXX, General Services Administration 17. Office of the Denver Regional
U.S.C. Chapter 35), the General Services
(GSA) Child Care Specialist Feedback Administrator (FAX8)
Administration has submitted to the
Form, in all correspondence. 18. Office of the San Francisco Regional
Office of Management and Budget
Dated: November 30, 2005
Administrator (FAX9)
(OMB) a request to review and approve
19. Office of the Seattle Regional
a new information collection Michael W. Carleton,
Administrator (FAXX)
requirement. This information will be Chief Information Officer. 20. Office of Operations Management
used to assess satisfaction with services [FR Doc. E5–8001 Filed 12–28–05; 8:45 am] (FAY)
delivered by staff from the Office of BILLING CODE 6820–A4–S 21. Office of Information Services (FBB)
Child Care Services. The respondents
22. Office of Financial Management
are current users of the Office of Child
(FBC)
Care Services. A request for public DEPARTMENT OF HEALTH AND 23. Office of Strategic Operations and
comments was published at 70 FR HUMAN SERVICES Regulatory Affairs (FGA)
56167, September 26, 2005. No
24. Office of E-Health Standards and
comments were received. Centers for Medicare & Medicaid Services (FHA)
Public comments are particularly Services 25. Office of Acquisition and Grants
invited on: Whether this collection of
Management (FKA)
information is necessary and whether it Statement of Organization, Functions,
26. Office of Policy (FLA)
will have practical utility; whether our and Delegations of Authority
estimate of the public burden of this • Section F. 20. (Functions) reads as
collection of information is accurate and Part F of the Statement of follows:
based on valid assumptions and Organization, Functions, and
Delegations of Authority for the 1. Office of External Affairs (FAC)
methodology; and ways to enhance the
quality, utility, and clarity of the Department of Health and Human • Serves as the focal point for the
information to be collected. Services, Centers for Medicare & Agency to the news media and provides
Medicaid Services (CMS), (Federal leadership for the Agency in the area of
DATES: Submit comments on or before:
Register, Vol. 62, No. 85, pp. 24120– intergovernmental affairs. Advises the
January 30, 2006. 24126, dated Friday, May 2, 1997, as Administrator and other Agency
FOR FURTHER INFORMATION CONTACT: Leo amended thereafter) is being components in all activities related to
G. Bonner, Regional Child Care republished to reflect the current the media and on matters that affect
Coordinator, Office of Child Care organizational structure of CMS in other units and levels of government.
Services, at telephone (202) 401–7403 or relation to meeting the Department’s • Coordinates CMS activities with the
via e-mail to leo.bonner@gsa.gov. goal of having no more than four Office of the Assistant Secretary for
ADDRESSES: Submit comments regarding management levels in the Agency and to Public Affairs and the Secretary’s
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this burden estimate or any other aspect also exercise leadership in intergovernmental affairs officials.
of this collection of information, implementing the Medicare Prescription • Serves as senior counsel to the
including suggestions for reducing this Drug, Improvement, and Modernization Administrator in all activities related to
burden to Ms. Jeanette Thornton, GSA Act of 2003 (MMA). the media. Provides consultation,
Desk Officer, OMB, Room 10236, NEOB, Part F is described below: advice, and training to the Agency’s

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77160 Federal Register / Vol. 70, No. 249 / Thursday, December 29, 2005 / Notices

senior staff with respect to relations information concerning populations • Develops national policies and
with the news media. affected by Agency programs; procedures related to the development,
• Develops and executes strategies to development of performance measures qualification and compliance of health
further the Agency’s relationship and and assessment programs; design and maintenance organizations, competitive
dealings with the media. Maintains a implementation of beneficiary services medical plans and other health care
broad based knowledge of the Agency’s initiatives; development of delivery systems and purchasing
structure, responsibilities, mission, communications channels and feedback arrangements (such as prospective pay,
goals, programs, and initiatives in order mechanisms within the Agency and case management, differential payment,
to provide or arrange for rapid and between the Agency and its selective contracting, etc.) necessary to
accurate response to news media needs. beneficiaries and their representatives; assure the effective administration of
• Prepares and edits appropriate and close collaboration with other the Agency’s programs, including the
materials about the Agency, its policies, Federal and State agencies and other development of statutory proposals.
actions and findings, and provides them stakeholders with a shared interest in • Handles all phases of contracts with
to the public through the print and better serving our beneficiaries. managed health care organizations
broadcast media. Develops and directs • Develops national policy for all eligible to provide care to Medicare
media relations strategies for the Medicare Parts A, B, C and D beneficiaries.
Agency. beneficiary eligibility, enrollment, • Coordinates the administration of
• Responds to inquiries from a broad entitlement; premium billing and individual benefits to assure appropriate
variety of news media, including major collection; coordination of benefits; focus on long term care, where
newspapers, national television and rights and protections; dispute applicable, and assumes responsibility
radio networks, national news resolution process; as well as policy for for the operational efforts related to the
magazines, local newspapers and radio managed care enrollment and payment aspects of long term care and
and television stations, publications disenrollment to assure the effective post-acute care services.
directed toward the Agency’s administration of the Medicare program, • Serves as the focal point for all
beneficiary populations, and newsletters including the development of related Agency interactions with employers,
serving the health care industry. legislative proposals. employees, retirees and others operating
• Manages press inquiries, • Oversees the development of on their behalf pertaining to issues
coordinates sensitive press issues, and privacy and confidentiality policies related to Agency policies and
develops policies and procedures for pertaining to the collection, use, and operations concerning employer
how press and media inquiries are release of individually identifiable data. sponsored prescription drug coverage
handled. • Coordinates beneficiary-centered for retirees.
• Arranges formal interviews for • Develops national policies and
information, education, and service
journalists with the Agency’s procedures to support and assure
initiatives.
Administrator or other appropriate appropriate State implementation of the
• Develops and tests new and
senior Agency staff; identifies for rules and processes governing group
innovative methods to improve
interviewees the issues to be addressed, and individual health insurance markets
beneficiary aspects of health care
and prepares or obtains background and the sale of health insurance policies
delivery systems through Title XVIII,
materials as needed. that supplement Medicare coverage.
• For significant Agency initiatives, XIX, and XXI demonstrations and other
• Primarily responsible for all
issues media advisories and arranges creative approaches to meeting the
operations related to Medicare
press conferences as appropriate; needs of Agency beneficiaries.
Prescription Drug Plans and Medicare
coordinates material and personnel as • Assures, in coordination with other
Advantage Prescription Drug (Part D)
necessary. Centers and Offices, the activities of
plans.
• Serves as liaison with the Medicare contractors, including • Performs activities related to the
Department of Health and Human managed care plans, agents, and State Medicare Parts A & B processes (42 CFR
Services and White House press offices. Agencies, meet the Agency’s part 405, subparts G and H), Part C (42
requirements on matters concerning CFR part 422, subpart M), Part D (42
2. Center for Beneficiary Choices (FAE) beneficiaries and other consumers. CFR part 423, subpart M) and the PACE
• Serves as Medicare Beneficiary • Plans and administers the contracts program for claims-related hearings,
Ombudsman, as well as the focal point and grants related to beneficiary and appeals, grievances and other dispute
for all Agency interactions with customer service, including the State resolution processes that are
beneficiaries, their families, care givers, Health Insurance Assistance Program beneficiary-centered.
health care providers, and others grants. • Develops, evaluates, and reviews
operating on their behalf concerning • Formulates strategies to advance regulations, guidelines, and instructions
improving beneficiary’s ability to make overall beneficiary communications required for the dissemination of
informed decisions about their health goals and coordinates the design and appeals policies to Medicare
and about program benefits publication process for all beneficiary- beneficiaries, Medicare contractors,
administered by the Agency. These centered information, education, and Medicare Advantage plans, Prescription
activities include strategic and service initiatives. Drug Plans, CMS regional offices,
implementation planning, execution, • Builds a range of partnerships with beneficiary advocacy groups and other
assessment and communications. other national organizations for effective interested parties.
• Assesses beneficiary and other consumer outreach, awareness, and
consumer needs, develops and oversees education efforts in support of Agency 3. Office of Legislation (FAF)
activities targeted to meet these needs, programs. • Provides leadership and executive
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and documents and disseminates results • Serves as the focal point for all direction within the Agency for
of these activities. These activities focus Agency interactions with managed legislative planning to address the
on Agency beneficiary service goals and health care organizations for issues Administration’s agenda.
objectives and include: Development of relating to Agency programs, policy and • Tracks, evaluates and develops
baseline and ongoing monitoring operations. provisions of annual legislative

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Federal Register / Vol. 70, No. 249 / Thursday, December 29, 2005 / Notices 77161

proposals for Medicare, Medicaid, standards (other than those directly • Serves as lead on current/proposed
Clinical Laboratory Improvement Act, related to survey and certification); legislation in order to determine impact
Health Insurance Portability and policies related to scope of benefits; and on provider and contractor operations.
Accountability Act and related statutes other statutory, regulatory, and • Develops national policy and
affecting health care financing quality contractual provisions. implementation of all Medicare Part A,
and access in concert with HCFA • Based on program data, develops Part B, and Part C premium billing and
components, the Department and the payment mechanisms, administrative collection activities and coordination of
Office of Management and Budget. mechanisms, and regulations to ensure benefits to assure effective
• Advances the legislative policy that CMS is purchasing medically administration of fee-for-service aspects
process through analysis, review and necessary services under fee-for-service. of the Medicare program.
development of health care initiatives • Writes payment and benefit-related
and issues. instructions for Medicare contractors. 5. Office of Equal Opportunity & Civil
• Develops the long-range legislative • Defines the scope of Medicare Rights (FAJ)
plans for the Agency in collaboration benefits and develops national fee-for- • Provides agency-wide leadership
with the CMS Centers and Offices. service payment policies, as necessary, and advice on issues of diversity, civil
• Participates with other CMS to assure the effective administration of rights, and promotion of a supportive
components in the development of the Agency’s programs, including the work environment for Agency
Agency policy, including implementing development of related statutory employees.
regulations and administrative actions. proposals. • Develops, implements and manages
• Manages pro-actively the Agency’s • Develops Agency medical coding affirmative employment programs.
response in times of heightened policies related to fee-for-service Provides principal advisory, advocacy,
congressional oversight of CMS in payments. and liaison services for the
collaboration with the Centers and • Provides administrative support to Administrator to Agency leadership and
Offices. Manages, coordinates and the Practicing Physician Advisory employees concerning equality in
develops policies for responding to Council. employment related issues to ensure a
congressional inquiries. • Coordinates provider, physician diverse workforce.
• Coordinates activities with the and contractor centered information,
• Develops Equal Employment
Office of the Assistant Secretary for education, and service initiatives.
Opportunity (EEO) and civil rights
Legislation (ASL) and serves as the • Serves as the CMS lead for
compliance policy for the Agency.
ASLs principal contact point on Medicare carrier and fiscal intermediary
Assesses the Agency’s compliance with
legislative and congressional relations. management, oversight, budget, and
applicable civil rights statutes,
• In collaboration with CMS Centers performance issues.
• Functions as CMS liaison for all executive orders, regulations, policies,
and Offices, provides technical
Medicare carrier and fiscal intermediary and programs.
assistance, consultation and information
program issues and, in close • Identifies policy and operational
services to congressional committees
collaboration with the regional offices issues and proposes solutions for
and individual members of Congress on
and other CMS components, coordinates resolving these issues in partnership
the Medicare and Medicaid programs,
the agency-wide contractor activities. with management, Office of the General
new CMS initiatives and pertinent
• Manages contractor instructions, Counsel, and other organizational
legislation.
• In collaboration with the CMS workload, and change management entities.
Centers and Offices, provides technical, process. • Receives and evaluates complaints
analytical, advisory and information • Collaborates with other CMS for procedural sufficiency; investigates,
services to the Agency’s components, components to establish ongoing adjudicates and resolves such
the Department, the White House, OMB, performance expectations for Medicare complaints.
other government agencies, private contractors (carriers and fiscal • Promotes the representation of
organizations and the general public on intermediaries) consistent with the minority groups, women, and
Agency legislation. agency’s goals; interprets, evaluates, and individuals with disabilities through
• Tracks and reports on legislation provides information on Medicare community outreach and other
relating to CMS programs and maintains contractors in terms of ongoing activities.
legislative reference library. compliance with performance • Resolves informal discrimination
• Coordinates the Agency’s requirements and expectations; complaints by means of EEO counseling
participation in congressional hearings, evaluates compliance with issued and/or Alternative Dispute Resolution.
including preparation of testimony and instructions; evaluates contractor- • Develops and analyzes data for
briefing materials, and covers all other specific performance and/or integrity internal and external reports reflecting
congressional hearings on matters of issues; and evaluates/monitors the diversity of the Agency workforce
interest to the Agency except corrective action, if necessary. and fairness in employment related
Appropriations Committee hearings • Manages, monitors, and provides actions. Makes recommendations to
specifically on the appropriation oversight of contractor (carriers and management on changes needed to
budget. fiscal intermediaries) transition ensure equal employment opportunity
activities including replacement of in every respect.
4. Center for Medicare Management departing contractors and the resulting • Serves as the internal advocate for
(FAH) transfer of workload, functional civil rights and related principles.
• Serves as the focal point for all realignments, and geographic workload Provides training, seminars, and
Agency interactions with health care carveouts. technical guidance to Agency staff.
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providers, intermediaries and carriers • Maintains and provides accurate


contractor specific information. 6. Office of Research, Development &
for issues relating to Agency fee-for-
Develops and implements long-term fee- Information (FAK)
service policies and operations.
• Monitors providers’ and other for-service contractor strategy, tactical • Provides analytic support and
entities’ conformance with quality plans, and other planning documents. information to the Administrator and

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the Executive Council needed to • Assures that the Agency’s quality- • Studies questions concerned with
establish Agency goals and directions. related activities (survey and financing present and future health
• Performs environmental scanning, certification, technical assistance, programs, evaluates operations of the
identifying, evaluating, and reporting beneficiary information, payment Federal Hospital Insurance Trust Fund
emerging trends in health care delivery policies and provider/plan incentives) and Supplementary Medical Insurance
and financing and their interactions are fully and effectively integrated. Trust Fund and performs microanalyses
with Agency programs. Carries out the Health Care Quality for the purpose of assessing the impact
• Manages strategic, crosscutting Improvement Program (HCQIP) for the of various health care financing factors
initiatives. Medicare, Medicaid, and CLIA upon the costs of Federal programs.
• Designs and conducts research and programs. • Estimates the financial effects of
evaluations of health care programs, • Leads in the specification and proposals to create national health
studying their impacts on beneficiaries, operational refinement of an integrated insurance systems or other national or
providers, plans, States and other CMS quality information system, which incremental health insurance reform.
partners and customers, designing and includes tools for measuring the • Develops and conducts studies to
assessing potential improvements, and coordination of care between health care estimate and project national and area
developing new measurement tools. settings; analyzes data supplied by that health expenditures.
• Coordinates all Agency system to identify opportunities to • Develops, maintains, and updates
demonstration activities, including improve care and assess success of provider market basket input price
development of the research and improvement interventions. indexes and the Medicare Economic
demonstration annual plan, evaluation • Develops requirements of Index.
of all Agency demonstrations, and participation for providers and plans in • Analyzes data on physicians’ costs
assistance to other components in the the Medicare, Medicaid, and CLIA and charges to develop payment indices
design of demonstrations and studies. programs. Revises requirements based and monitors expansion of service and
• Manages assigned demonstrations, on statutory change and input from inflation of costs in the health care
including Federal review, approval, and other components. sector.
• Operates the Medicare Peer Review • Performs actuarial reviews and
oversight; coordinates and participates
Organization and End Stage Renal audits of employee benefit expenses
with departmental components in
Disease Network program in charged to Medicare by fiscal
experimental health care delivery
conjunction with regional offices, intermediaries and carriers.
projects. • Publishes cost projections and
providing policies and procedures,
• Develops research, demonstration, economic analyses, and provides
contract design, program coordination,
and other publications and papers actuarial, technical advice and
and leadership in selected projects.
related to health care issues.
• Identifies, prioritizes and develops consultation to CMS components,
• Designs and conducts payment, content for clinical and health related governmental components, Congress,
purchasing, and benefits aspects of CMS’ Consumer Information and outside organizations.
demonstrations. Strategy; collaborates with other 9. Center for Medicaid and State
7. Office of Clinical Standards & components to develop comparative Operations (FAS)
Quality (FAM) provider and plan performance
information for consumer choices. • Serves as the focal point for all
• Serves as the focal point for all • Prepares the scientific, clinical, and Centers for Medicare & Medicaid
quality, clinical and medical science procedural basis for and recommends to Services activities relating to Medicaid,
issues and policies for the Agency’s the Administrator decisions regarding the State Children’s Health Insurance
programs. Provides leadership and coverage of new and established Program, the Clinical Laboratory
coordination for the development and technologies and services. Coordinates Improvement Act, the survey and
implementation of a cohesive, agency- activities of the Agency’s Technology certification of health facilities and all
wide approach to measuring and Advisory Committee and maintains interactions with States and local
promoting quality and leads the liaison with other departmental governments (including the Territories).
Agency’s priority-setting process for components regarding the safety and • Develops national Medicaid
clinical quality improvement. effectiveness of technologies and policies and procedures which support
Coordinates quality-related activities services; prepares the scientific and and assure effective State program
with outside organizations. Monitors clinical basis for, and recommends administration and beneficiary
quality of Medicare, Medicaid, and approaches to, quality-related medical protection. In partnership with States,
CLIA. Evaluates the success of review activities of carriers and evaluates the success of State agencies
interventions. payment policies. in carrying out their responsibilities
• Identifies and develops best and, as necessary, assists States in
practices and techniques in quality 8. Office of the Actuary (FAN) correcting problems and improving the
improvement; implementation of these • Conducts and directs the actuarial quality of their operations.
techniques will be overseen by program for CMS and directs the • Develops, interprets, and applies
appropriate components. Develops and development of and methodologies for specific laws, regulations, and policies
collaborates on demonstration projects macroeconomic analysis of health care that directly govern the financial
to test and promote quality financing issues. operation and management of the
measurement and improvement. • Performs actuarial, economic and Medicaid program and the related
• Develops, tests and evaluates, demographic studies to estimate CMS interactions with States and regional
adopts and supports performance program expenditures under current law offices.
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measurement systems (quality and under proposed modifications to • In coordination with other
indicators) to evaluate care provided to current law. components, develops, implements,
CMS beneficiaries except for • Provides program estimates for use evaluates and refines standardized
demonstration projects residing in other in the President’s budget and for reports provider performance measures used
components. required by Congress. within provider certification programs.

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Supports States in their use of oversight of the regional travel funding • Develops new policies and
standardized measures for provider allocation. recommends changes in existing
feedback and quality improvement • Manages procurement and national policies for CMS programs.
activities. Develops, implements and contracting activities, and personnel • Monitors the regional
supports the data collection and administration for the region. administrative budget, including
analysis systems needed by States to • Serves as principal CMS contact for oversight of the regional travel funding
administer the certification program. professional and provider/supplier allocation.
• Reviews, approves and conducts organizations in the region’s service • Manages procurement and
oversight of Medicaid managed care area. contracting activities and personnel
waiver programs. Provides assistance to • Oversees workplanning, facilities administration for the region.
States and external customers on all and property management, labor- • Serves as principal CMS contact for
Medicaid managed care issues. management relations, and staff training professional and provider/supplier
• Develops national policies and for the region. organizations in the region’s service
procedures on Medicaid automated • Initiates and directs the area.
claims/encounter processing and implementation of special regional and • Oversees work planning, facilities
information retrieval systems such as national projects. and property management, labor-
the Medicaid Management Information • Assures effective relationships management relations, and staff training
System (MMIS) and integrated within the region with State and local for the region.
eligibility determination systems. governments, beneficiaries and their • Initiates and directs the
• In coordination with the Office of representatives, and the media. implementation of special regional and
Financial Management (OFM), directs, • Coordinates with the DHHS national projects. Assures effective
coordinates, and monitors program Regional Director to assure effective relationships within the region with
integrity efforts and activities by States relationships with Congressional State and local governments,
and regions. Works with OFM to representatives and State and local beneficiaries and their representatives,
provide input in the development of governments. and the media.
program integrity policy. 11. Office of the New York Regional • Coordinates with the Department of
• Through administration of the Administrator (FAU2) Health and Human Services’ Regional
home and community-based services Director to ensure effective relationships
• Assures the effective administration
program and policy collaboration with with elected officials as well as State
of CMS programs and implements
other Agency components and the and local governments.
national policy at the regional level.
States, promotes the appropriate choice • Develops policy, participates in the 13. Office of the Atlanta Regional
and continuity of quality services formulation of new policy and Administrator (FAV4)
available to frail elderly, disabled and recommends changes in existing
chronically ill beneficiaries. • Directs the planning, coordination,
national policy for CMS programs.
• Develops and tests new and • Monitors the regional
and implementation of the programs
innovative methods to improve the under Titles XI, XVIII, and XIX of the
administrative budget, including
Medicaid program through Social Security Act and related statutes
oversight of the regional travel funding
demonstrations and best practices within the Agency’s regional/field
allocation.
including managing review, approval, • Manages procurement and offices that comprise the Atlanta and
and oversight of the Section 1115 contracting activities, automated data Dallas Regional Offices.
demonstrations. processing/local area network systems, • Provides executive leadership and
• Directs the planning, coordination, and personnel administration for the direction to the Agency’s Regional
and implementation of the survey, region. Administrator(s) in the Atlanta and
certification, and enforcement programs • Serves as principal CMS contact for Dallas Regional Offices.
for all Medicare and Medicaid providers professional and provider/supplier • Assures that the Agency’s programs
and suppliers, and for laboratories organizations in the region’s service are carried out in the most effective and
under the auspices of the Clinical area. efficient manner within the Atlanta and
Laboratory Improvement Act (CLIA). • Oversees workplanning, facilities Dallas Regional Offices, and that they
Reviews and approves applications by and property management, labor- are coordinated both at the Atlanta and
States for ‘‘exemption’’ from CLIA and management relations, and staff training Dallas level and with the Agency’s
applications from private accreditation for the region. headquarters’ offices.
organizations for deeming authority. • Initiates and directs the • Provides an Atlanta and Dallas
Develops assessment techniques and implementation of special regional and perspective to the Agency’s
protocols for periodically evaluating the national projects. Administrator and other members of the
performance of these entities. Monitors • Assures effective relationships Executive Council in such activities as
the performance of proficiency testing within the region with State and local strategic planning, determining the
programs under the auspices of CLIA. governments, beneficiaries and their effectiveness of the Agency’s programs
representatives, and the media. and policies, budget formulation and
10. Office of the Boston Regional • Coordinates with the Department of execution, legislation, and
Administrator (FAU1) Health and Human Services’ Regional administrative management.
• Assures the effective administration Director to assure effective relationships • Assures that the Agency’s national
of CMS programs and implements with Congressional representatives and policies, programs and special
national policy at the regional level. State and local governments. initiatives are implemented effectively
• Develops policy, participates in the throughout the Atlanta and Dallas
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formulation of new policy and 12. Office of the Philadelphia Regional Regional Offices. Conducts local
recommends changes in existing Administrator (FAU3) projects to improve the quality of
national policy for CMS programs. • Assures the effective administration medical care provided to beneficiaries
• Monitors the regional of CMS programs and implements and to control fraud, abuse and waste in
administrative budget, including national policy at the regional level. the Agency’s programs.

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• Evaluates progress in the existing national policy for CMS initiatives and broad cross-cutting
administration of the Agency’s programs programs. issues.
in the Atlanta and Dallas Regional • Develops and implements a
15. Office of the Dallas Regional
Offices, ensuring that required actions professional relations program within
Administrator (FAV6)
are taken to direct or redirect efforts the Region for all CMS programs and
and/or resources to achieve program serves as the principal CMS contact for • Provides executive leadership and
objectives. all professional organizations such as guidance on behalf of the Atlanta and
• Working with the Regional hospital and medical associations. Dallas Regional Administrators to CMS
Administrator(s) in the Atlanta and • Fully coordinates the Agency’s components at the regional level.
Dallas Regional Offices and the programs with other Health and Human • Serves on the Atlanta and Dallas
Agency’s headquarters’ leadership, Services’ components including the Leadership Council, which sets the
assures that the information needs of the Department’s Regional Director, other overall direction for the Regions, and
Medicare and Medicaid beneficiaries are Federal agencies, the Agency’s implements the Council’s directions
fully understood and met, to the contractors, State and local within the Region’s service area.
maximum degree possible. In governments, professional associations, • Effectively implements national
association with other Agency other interested groups, and the policy, programs, and special initiatives
components, maintains an Agency’s beneficiaries and/or at the regional level. Conducts local
understanding of the health care market representatives in the Region. projects to improve the quality of
that is operating in the Atlanta and • Manages procurement and medical care provided to beneficiaries
Dallas Regional Offices in order to allow contracting activities, ADP/LAN and to control fraud, abuse, and waste
the Agency to adapt to changes in that systems, and personnel actions for the in the Agency’s programs.
market when appropriate. Region. • Assures that the information needs
• Assures that the Regional • Provides regional perspective to the of the Medicare and Medicaid
Administrator(s) in the Atlanta and Administrator and the Executive beneficiaries are fully understood and
Dallas Regional Offices fully coordinate Council. met, to the maximum degree possible. In
the Agency’s programs with other association with other Agency
• Monitors the regional
Health and Human Services’ components, maintains an
administrative budget, including
components, other Federal agencies, the understanding of the health care market
oversight of the regional travel funding
Agency’s contractors, State and local that is operating in the Region in order
allocation.
governments, professional associations, to allow the Agency to adapt to changes
other interested groups, and the 14. Office of the Chicago Regional in that market when appropriate.
Agency’s beneficiaries and/or Administrator (FAW5) • Participates in the formulation of
representatives in their respective • Serves as the principal office for new policy and recommends changes in
region. Regional operations of CMS. existing national policy for CMS
• Working with the Agency’s programs.
• Directs the administration of all
headquarters, manages the Atlanta and • Develops and implements a
CMS programs within the region.
Dallas’ administrative budget, to include professional relations program within
• Sets the overall direction for the
the planning and allocation of resources the Region for all CMS programs and
Chicago and Kansas City Regional
to the regional offices comprising the serves as the principal CMS contact for
Offices through the Midwest
Atlanta and Dallas Regional Offices. all professional organizations such as
• Provides executive leadership and Consortium Advisory Board, and
hospital and medical associations.
guidance on behalf of the Atlanta and implements Board directions within the • Fully coordinates the Agency’s
Dallas Regional Administrator to CMS Region’s service area. programs with other Health and Human
components at the regional level. • Monitors the Regional Services’ components including the
• Serves on the Atlanta and Dallas administrative budget, including Department’s Regional Director, other
Leadership Council, which sets the oversight of the Regional travel funding Federal agencies, the Agency’s
overall direction for the Atlanta and allocation. contractors, State and local
Dallas Regional Offices, and implements • Manages procurement and governments, professional associations,
the Council’s directions within the contracting activities, ADP/LAN other interested groups, and the
Region’s service area. systems, and personnel actions for the Agency’s beneficiaries and/or
• Effectively implements national Region. representatives in the Region.
policy, programs, and special initiatives • Serves as principal CMS contact for • Manages procurement and
at the regional level. Conducts local professional and provider/supplier contracting activities, ADP/LAN
projects to improve the quality of organizations in the Region’s service systems, and personnel actions for the
medical care provided to beneficiaries area. Region.
and to control fraud, abuse, and waste • Oversees work planning, facilities • Provides regional perspective to the
in the Agency’s programs. and property management, labor- Administrator and the Executive
• Assures that the information needs management relations, merit promotion Council.
of the Medicare and Medicaid principles, EEO, and staff training for • Monitors the regional
beneficiaries are fully understood and the Region. administrative budget, including
met, to the maximum degree possible. In • Coordinates environmental oversight of the regional travel funding
association with other Agency scanning and strategic planning for the allocation.
components, maintains an Region. Pursues activities which enable
understanding of the health care market the Regional staff to become 16. Office of the Kansas City Regional
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that is operating in the Region in order knowledgeable regarding developments Administrator (FAW7)
to allow the Agency to adapt to changes and trends in health care delivery • Serves as the principal official for
in that market when appropriate. within the States they serve. regional operations of CMS and directs
• Participates in the formulation of • Serves as focal point among the administration of all CMS programs
new policy and recommends changes in Regional Office components for special within the region.

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• Directs the Consortium Survey and • Evaluates diverse needs of • Manages the human and dollar
Certification and Consortium Contractor constituents in the region and advises resources of the regional office in an
Management organizations. policy makers so that such needs are efficient and effective manner including
• Monitors the regional considered by CMS in national policy work planning, facilities and property
administrative budget, including development. management, human resource
oversight of the regional travel funding • Develops expert opinion to advise management (recruitment, retention,
allocation. national policy makers on concerns of training, development and performance
• Develops and implements a media American Indians and Alaska Natives as management), and labor-management
relations plan to market CMS programs they relate to programs administered by relations.
to the diverse populations of the region. HHS. • Coordinates with the Department’s
• Manages procurement and Regional Director to assure effective
contracting activities, ADP/LAN 18. Office of the San Francisco Regional
Administrator (FAX9) relations with State and local
systems, and personnel actions for the governments and with other
Region. • The Office of the Regional Departmental programs and offices.
• Oversees work planning, facilities Administrator directs the operations of • Evaluates diverse needs of
and property management, labor- programs administered by the CMS, constituents in the region and advises
management relations, merit promotion including Medicare, Medicaid, Clinical policy makers so that such needs are
principles, EEO and staff training for the Laboratory Improvement Act, and considered by CMS in national policy
region. Health Insurance Portability and development.
• Coordinates environmental Accountability Act, in a distinct • Designs and implements health care
scanning and strategic planning for the geographic area and provides executive quality improvement projects and
region. Pursues activities which enable leadership to regional office staff on manages contracts of peer review
the Chicago and Kansas City regional behalf of the CMS Administrator. organizations to improve health care
staff to become knowledgeable regarding • Develops and implements an
quality in 13 Western States.
developments and trends in health care outreach plan which includes media
delivery within the states they serve. relations, community participation, 20. Office of Operations Management
• Serves as the focal point among speeches and presentations, and local (FAY)
regional office components for special Congressional office liaison, to market • Prepares and presents
initiatives and broad cross-cutting CMS programs to the diverse recommendations to the Administrator,
issues. populations of the region. Deputy Administrator, Chief Operating
• Manages and executes the Health • Manages the human and dollar
Officer and other high-level CMS and
Insurance Portability and resources of the regional office in an
Department officials on planning,
Accountability Act’s insurance efficient and effective manner including
leadership, implementation and policy
portability enforcement process for the work planning, facilities and property
issues concerning modifications to
nation. management, human resource
existing and proposed operating policies
management (recruitment, retention,
17. Office of the Denver Regional that will improve the administration
training, development and performance
Administrator (FAX8) and operations of programs and the
management), and labor-management
• The Office of the Regional Agency as a whole.
relations.
Administrator directs the operations of • Coordinates with the Department’s • Provides consulting services
programs administered by the CMS, Regional Director to assure effective internally to Agency management and
including Medicare, Medicaid, Clinical relations with State and local staff to identify processes that need
Laboratory Improvement Act, and governments and with other improvement, to develop improvement
Health Insurance Portability and Departmental programs and offices. strategies, and to monitor processes and
Accountability Act, in a distinct • Evaluates diverse needs of improvements over time. Participates in
geographic area and provides executive constituents in the region and advises agency-wide initiatives to streamline
leadership to regional office staff on policy makers so that such needs are operations, improve accountability and
behalf of the CMS Administrator. considered by CMS in national policy performance, and implement
• Develops and implements an development. management best practices.
outreach plan which includes media • Promotes project planning
relations, community participation, 19. Office of the Seattle Regional principles throughout the Agency and
speeches and presentations, and local Administrator (FAXX) provides technical guidance to the
Congressional office liaison, to market • The Office of the Regional Agency on project planning and
CMS programs to the diverse Administrator directs the operations of management techniques. Prepares and
populations of the region. programs administered by the CMS, presents recommendations to senior
• Manages the human and dollar including Medicare, Medicaid, Clinical officials regarding major projects.
resources of the regional office in an Laboratory Improvement Act, and • Promotes and teaches risk
efficient and effective manner including Health Insurance Portability and assessment methods to business owners
work planning, facilities and property Accountability Act, in a distinct throughout CMS. Promotes awareness of
management, human resource geographic area and provides executive the importance of risk analysis as a
management (recruitment, retention, leadership to regional office staff on component of business planning and
training, development and performance behalf of the CMS Administrator. trains CMS staff in specific techniques
management), and labor-management • Develops and implements an and their applicability in particular
relations. outreach plan which includes media situations.
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• Coordinates with the Department’s relations, community participation, • Identifies operational


Regional Director to assure effective speeches and presentations, and local vulnerabilities within CMS and
relations with State and local Congressional office liaison, to market develops and executes an operational
governments and with other CMS programs to the diverse review plan for each fiscal year, subject
Departmental programs and offices. populations of the region. to approval by the Deputy

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77166 Federal Register / Vol. 70, No. 249 / Thursday, December 29, 2005 / Notices

Administrator, Chief Operating Officer practices in all areas of information the funding of the State survey/
and other senior leadership of CMS. technology. certification and the CLIA programs. Is
• Plans and conducts targeted • Develops and maintains enterprise- responsible for all Agency
internal audits and makes wide central databases, statistical files, disbursements.
recommendations to strengthen internal and general access paths, ensuring the • Performs cash management
audits and improve the operations of the quality of information maintained in activities and establishes and maintains
Agency. these data sources. systems to control the obligation of
• Serves as the Agency focal point for • Directs Medicare claims payment funds and ensure that the Anti-
emergency preparedness. systems activities, including CWF Deficiency Act is not violated.
• Provides the Agency’s internal operation, as well as systems conversion • Performs the Agency’s debt
customers (employees) with support in activities. management activities (e.g., accounts
human resource management, • Develops ADP standards and receivable, user fees, penalties,
procurement management, and logistics. policies for use by internal CMS staff disallowances).
Includes planning, organizing, and contractor agents in such areas as • Reconciles all Agency financial data
coordinating, and evaluating needed applications development and use of the and prepares external reports to other
activities in each area. infrastructure resources. agencies such as HHS, Treasury, OMB,
• Manages and directs the Agency’s • Manages and directs the operation Internal Revenue Service, General
ethics and management programs; of CMS hardware infrastructure, Services Administration, related to the
provides policy direction, coordination including the Agency’s Data Center, Agency’s obligations, expenditures,
and support for administrative services data communications networks, prompt payment activities, debt and
including space, property, records, enterprise infrastructure, voice/data cash management, and other
printing and facilities management, switch, audio conferencing and other administrative functions.
safety and security, and a centralized data centers supporting CMS programs. • Has overall responsibility for the
customer service desk. • Leads the coordination, fiscal integrity of all Agency programs.
development, implementation and Develops and performs all benefit
• Provides administrative support
maintenance of health care information integrity policy and operations in
functions for the Commissioned Corps.
standards in the health care industry. coordination with other Agency
• Develops and maintains
• Provides Medicare and Medicaid components. Manages the Medicare
administrative systems for ethics,
information to the public, within the program integrity contractors authorized
awards, procurement, and property
parameters imposed by the Privacy Act. by the HIPAA and managed care
management. • Performs information collection financial audit and enforcement
• Provides staff support to the analyses as necessary to satisfy the functions. In coordination with the
Provider Reimbursement Review Board requirements of the Paperwork Center for Medicaid and State
(PRRB) and the Medicare Geographic Reduction Act. Operations, develops Medicaid program
Review Board (MGCRB). • Directs CMS’ ADP systems security integrity policy; and monitors Medicaid
• Conducts Medicare and Medicaid program with respect to data, hardware, program integrity activities.
Hearings on behalf of the Secretary or and software. • Working with other CMS
the Administrator that are not within • Directs and advises the components, develops Agency policies
the jurisdiction of the Department Administrator, senior staff, and governing both Medicare Secondary
Appeals Board, the Social Security components on the requirements, Payer and Medicaid Third Party
Administration’s Office of Hearings and policies, and administration of the Liability.
Appeals, the PRRB, the MGCRB, or the Privacy Act. • Develops and implements all civil
States. money penalty policies in all programs.
22. Office of Financial Management
21. Office of Information Services (FBB) • Prepares financial statements for
(FBC)
Federal Managers Financial Integrity
• Serves as the focal point for the • Serves as the Chief Financial Act and GPRA.
responsibilities of the Agency’s Chief Officer and Comptroller for the Agency.
Information Officer in planning, • Formulates, presents and executes 23. Office of Strategic Operations &
organizing, and coordinating the all Agency budget accounts; develops Regulatory Affairs (FGA)
activities required to maintain an outlay plans and tracks contract and • Manages the Agency’s decision-
agency-wide Information Resources grant award amounts; acts as liaison making and regulatory process.
Management (IRM) program. with the Congressional Budget Office • Serves in a neutral broker
• Ensures the effective management (CBO) on budget estimates; reviews coordination role which includes:
of the Agency’s information technology, demonstration waivers (except 1115) for Scheduling meetings and briefings for
and information systems and resources revenue neutrality. Is responsible for the Administrator and coordinating
(e.g., implementation and ensuring that the budget is formulated communications between and among
administration of a change management in accordance with the Agency’s central and regional offices to ensure
process). strategic plan and the GPRA goals and that emerging issues are identified early,
• Provides workstation, server, and performance measures. all concerned components are directly
local area network support for CMS- • Acts as liaison with ASMB, OMB, and fully involved in policy
wide activities. Works with customer and the Congressional appropriations development/decision making, and that
components to develop requirements, committees for all matters concerning all points of view are presented.
needs and cost benefit analysis in the Agency’s operating budget. • Provides leadership, direction, and
support of the LAN infrastructure • Manages the Medicare financial advocacy, on behalf of top CMS officials
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including hardware, software and office management system, the Medicare in connection with official policy
automation services. contractors’ budgets, Peer Review matters for presentation to the
• Serves as the lead for developing Organizations’ budgets, research Administrator and Deputy
and enforcing the Agency’s information budgets, managed care payments, the Administrator/ Chief Operating Officer
architecture, policies, standards, and issuance of State Medicaid grants, and to insure that all points of view and

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program interests of concern to the • Acts as audit liaison with the • Promotes and leverages innovative
Administrator and Deputy General Accounting Office (GAO) and component initiatives. Facilitates cross-
Administrator/Chief Operating Officer the HHS Office of Inspector General component awareness of various e-
are developed and properly presented (OIG). health projects.
for consideration. Reviews policy • Monitors and coordinates major • Develops regulations and guidance
statements by component Directors and CMS legislative initiatives such as materials, and provides technical
others to anticipate potential problems tracking the status of the Agency’s assistance on the Administrative
or inconsistencies with views of the implementation of Balance Budget Act, Simplification provisions of the Health
Administrator, Deputy Administrator/ Balanced Budget Refinement Act, and Insurance Portability and
Chief Operating Officer, and the the Benefits Improvement and Accountability Act of 1996 (HIPAA),
Administration. Assists in resolving Protection Act provisions. including transactions, code sets,
these matters to the satisfaction of the • Coordinates and prepares the identifiers, and security.
Agency and top management. advance planning reports for the • Develops and implements the
• Manages meeting requests for or on Secretary and the Administrator enforcement program for HIPAA
behalf of the Administrator, and Deputy (Secretary’s Forecast Report). Administrative Simplification
Administrator/Chief Operating Officer. • Acts as the liaison with the Office provisions.
Coordinates the preparation of briefing of the Secretary for Reports to the • Develops and implements an
materials for the Administrator, Deputy Congress and maintains a tracking outreach program for HIPAA
Administrator/Chief Operating Officer, system to monitor status. Also serves as Administrative Simplification
and the Department in advance of the the CMS liaison with the Small provisions. Formulates and coordinates
Administrator and Deputy Business Administration’s Office of the a public relations campaign, prepares
Administrator/Chief Operating Officer’s National Ombudsman. and delivers presentations and
participation in meetings, appointments • Develops standard processes for all speeches, responds to inquiries on
with major groups, etc. Works with CMS CMS FACA committees and provides HIPAA issues, and maintains liaison
components to assure that appropriate operational and logistical support to with industry representatives.
briefing materials are presented to CMS components for conferences and • Adopts and maintains messaging
Senior Leadership. Senior officials in on all matters relating to Federal and vocabulary standards supporting
CMS and the Department, as well as Advisory Committees. electronic prescribing under Medicare
officials of other Federal agencies, State • Conducts activities necessary to the Part D.
and local governments, and outside receipt, management, response, and • Serves as agency point of reference
interest groups attend these meetings. reporting requirements of the on Federal and private sector e-Health
Department under the Freedom of initiatives. Works with Federal
• Coordinates the preparation of
Information Act (FOIA) regarding all departments and agencies to identify
manuals and other policy instructions to
requests received by CMS. and adopt universal messaging and
ensure accurate and consistent
• Maintains a log of all FOIA requests clinical health data standards, and
implementation of the Agency’s
received by the central office, refers represents CMS and HHS in national
programs.
requests to the appropriate components projects supporting the national health
• Manages the Agency’s system for within headquarters, the regions or
developing, clearing and tracking enterprise architecture and the national
among carriers and intermediaries for health information infrastructure.
regulations, setting regulation priorities the collection of the documents • Coordinates and provides guidance
and corresponding work agendas; requested. Makes recommendations and on legislative and regulatory issues
coordinates the review of regulations prepares replies to requesters, including related to e-health standards and
received for concurrence from denials of information as permitted services.
departmental and other government under FOIA, and drafts briefing • Collaborates with HHS on policy
agencies, and develops routine and materials and responses in connection issues related to e-health standards, and
special reports on the Agency’s with appeals of denial decisions. serves as the central point of contact for
regulatory activities. • Directs the maintaining and the Office of the National Coordinator
• Manages the regulations amending of CMS-wide records for for Health Information Technology.
development process to ensure timely confidentiality and disclosure to the
decision making by the Administrator Privacy Act to include: Planning, 25. Office of Acquisition & Grants
and Deputy Administrator/Chief organizing, initiating and controlling Management (FKA)
Operating Officer on CMS regulations. privacy matching assignments. • Serves as the Agency’s Head of the
• Provides leadership and • Provides direct services and Contracting Activity. Plans, organizes,
management of the Agency’s Executive develops policy, standards, and coordinates and manages the activities
Correspondence system. Operates the procedures for CMS’ records, required to maintain an agency-wide
agency-wide correspondence tracking management and vital records program acquisition program.
and control system and provides for all CMS Central and Regional • Serves as the Agency’s Chief Grants
guidance and technical assistance on Offices. Management Official, with
standards for content of correspondence responsibility for all CMS discretionary
and memoranda. 24. Office of E-Health Standards and
grants.
• Manages the agency-wide clearance Services (FHA) • Ensures the effective management
system to ensure appropriate • Develops and coordinates of the Agency’s acquisition and grant
involvement from Agency components implementation of a comprehensive e- resources.
and serves as a primary focal point for health strategy for CMS. Coordinates • Serves as the lead for developing
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liaison with the Executive Secretariat in and supports internal and external and overseeing the Agency’s acquisition
the Office of the Secretary. technical activities related to e-health planning efforts.
• Provides management and services and ensures that individual • Develops policy and procedures for
administrative support to the Office of initiatives tie to the overall agency and use by acquisition staff and internal
the Attorney Advisor and staff. Federal e-health goals strategies. CMS staff necessary to maintain

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77168 Federal Register / Vol. 70, No. 249 / Thursday, December 29, 2005 / Notices

efficient and effective acquisition and • Performs environmental scanning, Program (the Site Tours Program). The
grant programs. identifying, evaluating, and reporting purpose of this notice is to invite
• Advises and assists the emerging trends to health care delivery pharmaceutical companies interested in
Administrator, senior staff, and Agency and financing. Works with Agency participating in this program to contact
components on acquisition and grant components and outside organizations CDER.
related issues. to obtain relevant information on DATES: Pharmaceutical companies may
• Plans, develops, and interprets emerging trends. Analyzes trends for submit proposed agendas to the agency
comprehensive policies, procedures, their interactions with Agency programs by February 27, 2006.
regulations, and directives for CMS and implications for future policy FOR FURTHER INFORMATION CONTACT: Beth
acquisition functions. development and planning. Identifies Duvall-Miller, Office of New Drugs
• Represents CMS at departmental emerging trends and policy issues that (HFD–020), Center for Drug Evaluation
acquisition and grant forums and would benefit the Office of Research, and Research, Food and Drug
functions, such as the Executive Council Development, and Information’s Administration, 10903 New Hampshire
on Acquisition and the Executive research, evaluation, and survey Ave., Bldg 22, rm. 6466, Silver Spring,
Council for Grants Administration enterprises. MD 20903, 301–796–0700, FAX: 301–
Policy. • Conducts management and 796–9858.
• Serves as the CMS contact point development of the long-term strategic
with HHS and other Federal agencies SUPPLEMENTARY INFORMATION:
plan for the Agency. Provides analytic
relative to grant and cooperative support and information to the I. Background
agreement policy matters. Administrator and Senior Leadership
• Coordinates and/or conducts An important part of CDER’s
needed to establish the Agency’s goals commitment to make safe and effective
training for contracts and grant and directions. Conducts special studies
personnel, as well as project officers in drugs available to all Americans is
and analyses concerning Agency-wide optimizing the efficiency and quality of
CMS components. planning issues.
• Develops agency-specific the drug review process. To support this
• Provides data analyses, graphics primary goal, the Center has initiated
procurement guidelines for the presentations, briefing materials, and
utilization of small and disadvantaged various training and development
analyses on short notice to support the programs to promote high performance
business concerns in achieving an immediate needs of the Administrator
equitable percentage of CMS’ in its regulatory project management
and Senior Leadership. staff. CDER seeks to significantly
contracting requirements. • Manages strategic, cross-cutting
• Provides cost/price analyses and enhance review efficiency and review
initiatives as assigned by the Office of
evaluations required for the review, quality by providing the staff with a
the Administrator.
negotiation, award, administration, and better understanding of the
• Facilitates policy development by
closeout of grants and contracts. pharmaceutical industry and its
providing analytic liaison with other
Provides support for field audit operations. To this end, CDER is
components in HHS and elsewhere in
capability during the pre-award and continuing its training program to give
the Administration.
closeout phases of contract and grant • Serves as CMS’ contact for regulatory project managers the
activities. international visitors. Responds to opportunity to tour pharmaceutical
• Develops and maintains the OAGM requests from intergovernmental facilities. The goals are to provide the
automated procurement management agencies and the international following: (1) First hand exposure to
system. Manages procurement community for information related to industry’s drug development processes
information activities (i.e., collecting, the United States health care system. and (2) a venue for sharing information
reporting, and analyzing procurement about project management procedures
Dated: December 20, 2005. (but not drug-specific information) with
data).
Karen Pelham O’Steen, industry representatives.
26. Office of Policy (FLA) Director, Office of Operations Management,
II. Regulatory Project Management Site
• Assists the Policy Council with Centers for Medicare & Medicaid Services.
[FR Doc. E5–8073 Filed 12–28–05; 8:45 am]
Tours and Regulatory Interaction
immediate/rapid response on timely
Program
issues and transform concepts into BILLING CODE 4120–01–P
institutionalized processes. In this program, over a 2- to 3-day
• Assists the MMA Council as period, small groups (five or less) of
requested to develop, implement, and DEPARTMENT OF HEALTH AND regulatory project managers, including a
coordinate a policy process for the HUMAN SERVICES senior level regulatory project manager,
agency for key major cross-cutting and can observe operations of
policy issues resulting from MMA Food and Drug Administration pharmaceutical manufacturing and/or
legislation and subsequent issues. packaging facilities, pathology/
Training Program for Regulatory
• Advises the Administrator on toxicology laboratories, and regulatory
Project Managers; Information affairs operations. Neither this tour nor
medical technical innovation and health
Available to Industry any part of the program is intended as
information technology matters.
• Plans and develops future CMS AGENCY: Food and Drug Administration, a mechanism to inspect, assess, judge,
program policy. Assists OL in the HHS. or perform a regulatory function, but is
development of legislative strategies by ACTION: Notice. meant rather to improve mutual
providing analytic support for understanding and to provide an avenue
legislative options and proposals. SUMMARY: The Food and Drug for open dialogue. During the Site Tours
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Conducts legislative, economic, and Administration (FDA) Center for Drug Program, regulatory project managers
policy analyses related to the overall Evaluation and Research (CDER) is will also participate in daily workshops
structure of health care financing. announcing the continuation of the with their industry counterparts,
Translates research findings into policy Regulatory Project Management Site focusing on selective regulatory issues
applications. Tours and Regulatory Interaction important to both CDER staff and

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