69570 Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food Labeling; Notification Procedures 

for Statements on Dietary 

Supplements—(OMB Control Number 

0910–0331)—Extension 

Section 403(r)(6) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C 343(r)(6)) requires that FDA be 

notified by manufacturers, packers, and 

distributors of dietary supplements that 

they are marketing a dietary supplement 

product that bears on its label or in its 

labeling a statement provided for in 

section 403(r)(6) of the act. Section 

403(r)(6) of the act requires that FDA be 

notified, with a submission about such 

statements, no later than 30 days after 

the first marketing of the dietary 

supplement. Information that is 

required in the submission includes the 

following: (1) The name and address of 

the manufacturer, packer, or distributor 

of the dietary supplement product; (2) 

the text of the statement that is being 

made; (3) the name of the dietary 

ingredient or supplement that is the 

subject of the statement; (4) the name of 

the dietary supplement (including the 

brand name); and (5) a signature of a 

responsible individual who can certify 

the accuracy of the information 

presented, and who must certify that the 

information contained in the notice is 

complete and accurate, and that the 

notifying firm has substantiation that 

the statement is truthful and not 

misleading. 

FDA established § 101.93 (21 CFR 

101.93) as the procedural regulation for 

this program. Section 101.93 provides 

details of the procedures associated 

with the submission and identifies the 

information that must be included in 

order to meet the requirements of 

section 403 of the act. 

Description of Respondents: 

Businesses or other for-profit 

organizations. 

In the Federal Register of July 24, 

2006 (71 FR 41818), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received 

before the comment period closed. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

respondents 

Annual frequency 

per response Total annual responses Hours per response Total hours 

101.93 2,500 1 2,500 .75 1,875 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA believes that there will be 

minimal burden on the industry to 

generate information to meet the 

requirements of section 403 of the act in 

submitting information regarding 

section 403(r)(6) of the act statements on 

labels or in labeling of dietary 

supplements. FDA is requesting only 

information that is immediately 

available to the manufacturer, packer, or 

distributor of the dietary supplement 

that bears such a statement on its label 

or in its labeling. This estimate is based 

on the average number of notification 

submissions received by FDA in the 

preceding 12 months. 

Dated: November 21, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–20307 Filed 12–01–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Navajo Area Indian Health Service 

(GFJ); Organization, Functions, and 

Delegations of Authority 

Office of the Area Director (GFJ1) 

(1) Plans, develops and directs the 

Area Program within the framework of 

Indian Health Service (IHS) policy in 

pursuit of the IHS mission; (2) delivers 

and ensures the delivery of high quality 

comprehensive health services; (3) 

coordinates the IHS activities and 

resources internally and externally with 

those of other governmental and 

nongovernmental programs; (4) 

promotes optimum utilization of health 

care services through management and 

delivery of services to American Indians 

and Alaska Natives; (5) encourages the 

full application of the principles of 

Indian preference and Equal 

Employment Opportunity (EEO); and (6) 

provides Indian Tribes and other Indian 

community groups with optional ways 

of participating in the Indian Health 

programs including an opportunity to 

participate in developing the mission, 

values and goals for the Navajo Area 

Indian Health Service (NAIHS). 

Equal Employment Opportunity Staff 

(GFJ1) 

(1) Advises the Area Director and 

other key management officials in the 

execution of their IHS responsibilities; 

(2) provides program direction and 

leadership for the Area EEO program 

and procedures; and (3) ensures the 

elimination of discrimination practices 

in employment, promotion, training, 

treatment of applicants, and employees, 

because of race, color, religion, national 

origin, sex, age, and handicapping 

conditions. 

Office of Administration and 

Management (GFJ2) 

(1) Plans, directs, and coordinates 

NAIHS activities in the areas of policy, 

internal controls reviews, financial 

management, personnel management, 

third-party reimbursements; contract 

health services (CHS) funds; contracts 

management, procurement, personal 

property accountability/management, 

and administrative services; (2) serves 

as the Navajo Area principal advisor on 

all Area organization and management 

policy activities; and (3) provides 

guidance and assistance to service units 

in the overall development, planning 

and implementation of administrative 

functions. 


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Third-Party Resources Staff (GFJ2) 

(1) Establishes liaison and coordinates 

Medicare/Medicaid activities with 

States agencies; (2) plans and 

coordinates the third-party activities of 

NAIHS facilities, develops policy 

pertaining to third-party activities, and 

coordinates and develops overall policy 

and plans for the implementation of 

Title IV, Public Law (Pub. L.) 94–437, 

Indian Health Care Improvement Act; 

and (3) provides technical assistance 

and guidance to service unit third-party 

staff. 

Contract Health Services Branch (GFJ21) 

(1) Establishes and provides 

organization, coordination, and 

implementation of policies and 

procedures for CHS operations, utilizing 

managed care concepts; (2) coordinates 

the development of an annual budget, 

with advice of allowance, for CHS fund 

control activities; (4) coordinates and 

evaluates medical, preventive, and 

hospital services provided through 

formal contractual procedures; (5) 

implements and administers a CHS 

quality assurance program that is data 

based and verifiable, for monitoring the 

quality of CHS; (6) establishes strategic 

CHS plans that are developed to support 

organizations, issues, or work processes; 

(7) coordinates and implements 

information resource related processes 

that integrates selected techniques/ 

methods with CHS systems to solve 

processes/problems; and (8) coordinates 

and analyzes appeal cases, high cost 

care cases, and deferred CHS services. 

Division of Financial Management 

(GFJ22) 

(1) Provides direction for the 

organization, coordination, and 

execution of all budget and financial 

operations of the Area; (2) monitors 

fund control operations of service units, 

and program offices; (3) develops and 

implements budget, fiscal, and 

accounting procedures; (4) conducts 

reviews and analyses to ensure 

compliance with Area policy; (5) 

interprets policies, guidelines, manual 

issuances, Office of Management and 

Budget (OMB) circulars, directives and 

other instructions issued by IHS, Health 

Resources Services Administration 

(HRSA), Public Health Service (PHS), 

Department of Health Human Services 

(HHS), OMB, and Congress as it related 

to the formulation of Area and service 

units budgets and budget execution; (6) 

develops and makes recommendations 

of Area budget execution by service 

unit; (7) establishes and maintains 

memorandum accounts of obligations 

for allowances through use of 

commitment registers; and (8) monitors 

and ensure proper obligation of prior 

year funds. 

Travel and Debt Management (GFJ22) 

(1) Provides interpretation and ensure 

compliance with operating policies, 

procedures, guidelines via Federal 

Travel Regulations, Federal Property 

Management Regulations, Joint Travel 

Regulations, HHS Travel Manual, Indian 

Health Manual—Travel Management, 

etc.; and (2) develops and implements 

Area-wide internal controls and ensures 

compliance with established policies, 

procedures and regulations. 

Budget Branch (GFJ221) 

(1) Ensures that accurate and current 

information is available at all times for 

the Navajo Area Executive Staff, 

Division Chiefs, and service unit 

management teams; and (2) ensures that 

funds are allotted properly and 

accounted for in line with acceptable 

Federal accounting practices. Analyzes 

obligation trends and prepares periodic 

reports. 

Accounting Branch (GFJ222) 

(1) Provides advice and guidance to 

Area and service unit staff in the areas 

of collection, imprest funds, accounts 

receivable, and internal audit. Advises 

Area and service unit staff on the 

interpretation of accounting data and 

reports received from IHS Headquarters 

(HQ); and (2) assures that accounting 

transactions are entered properly and 

prepares periodic or special purpose 

reports and financial statements for 

Area Divisions and service units. 

Division of Administrative Services 

(GFJ23) 

(1) Plans, develops, coordinates, and 

provides internal audit activities, office 

services, records management and 

delegation/directives control, personal 

property management, and other 

administrative services in support of 

Area programs; (2) provides guidance to 

service units in the operation and 

evaluation of procurement and 

acquisition of equipment, office 

services, telecommunications (voice), 

and transportation; (3) develops and 

executes administrative management 

systems, methods, and techniques 

designed to organize, maintain, monitor, 

evaluate, and report on the 

administrative aspects of the Area-wide 

supply management program in support 

of requirements and authorities of IHS, 

PHS, and HHS; (4) serves as the 

administrative authority on Federal 

personal property management laws, 

rules, regulations, policies, procedures, 

and practices; and (5) organizes, 

maintains, monitors, evaluates, and 

reports on the acquisition, control, 

utilization, and disposition of personal 

property. 

Directives Controls—Delegations & 

Records Management 

Directives and Delegations Control 

(1) Advises staff on the procedures for 

the development, revision, or 

cancellation of Area-issued directives 

and delegations; (2) ensures that Area 

and service unit personnel are afforded 

the opportunity to comment on draft 

IHS and NAIHS directives; (3) provides 

policy interpretation of Area-issued 

directives and delegations; and (4) 

maintains complete sets of IHS and 

NAIHS directives and delegations. 

Records Management 

(1) Must ensure comprehensive 

knowledge of regulatory and statutory 

requirements associated with the three 

records management processes of 

creation, maintenance, and disposition 

of records; (2) plans, develops, and 

implements uniform records 

management practices, training, and 

compliance reviews; (3) provides 

technical assistance as requested at 

individual file stations; (4) assists in the 

transfer and retrieval of Area and 

service unit records with the National 

Archives and Records Administration 

and other Federal agencies; and (5) 

ensures that the maintenance and 

disposition of records is in accordance 

with records schedules approved by the 

Archivist of the United States. 

Office Services 

(1) Provides leadership, direction, and 

supervision in the planning, 

development, and operation of printing/ 

duplicating management, security 

management, vehicle management, mail 

systems management, 

telecommunications management 

(voice); (2) ensures transportation 

management for household goods (HHG) 

protocols are followed specific to 

regulatory requirements for both 

commissioned corps and civil service 

employees by providing guidance on 

HHG practices, training, and reviews; 

(3) maintains inventories of office 

supplies at the Gallup Regional Supply 

Service Center (GRSSC); and (4) 

provides forms/correspondence 

management and monitors form 

accountability in conjunction with the 

GRSSC. 

Internal Audit Branch 

(1) Plans, implements, coordinates 

and monitors all audit functions 

applicable to programs and operations; 

(2) provides annually an assessment on 


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the adequacy and effectiveness of 

processes for controlling activities and 

managing risks in program areas; (3) 

reports significant issues related to the 

processes for controlling the activities of 

the Area and its affiliates, including 

potential improvements to those 

processes, and provides information 

concerning such issues through 

resolution; (4) periodically provides 

information on the status and results of 

an annual audit plan and the sufficiency 

of department resources; (5) coordinates 

with other control and monitoring 

functions (risk management, 

compliance, security, legal, ethics, 

environmental, external audit); and (6) 

performs evaluations, development, 

implementation, technical assistance 

and consultation in accordance with 

audit standards established by 

Comptroller and Office of Inspector 

General for audits of Federal 

organizations, program activities, and 

functions. 

Property Management Branch (GFJ232) 

(1) Provides leadership, direction and 

overall management of all personal 

property in key areas of accountability, 

utilization, control, and disposal; (2) 

provides guidance on Area property 

management procedures including 

property accounting and reporting 

instructions; (3) executes physical 

inventories including the reconciliation 

of inventory reports and standard 

general ledger accounts; (4) documents 

all transactions affecting personal 

property; and (5) provides technical 

assistance Area-wide on property 

software packages, e.g. Sunflower 

Assets, FoxPro. 

Supply Management Branch (GRSSC) 

(GFJ234) 

(1) Provides overall management of 

expendable supplies to include 

reliability, timeliness, quality, service 

and cost effectiveness; (2) directs and 

supplies pharmaceutical, laboratory, 

dental, medical, administrative, 

subsistence, and general supply items; 

(3) plans, develops, and manages the 

supply budget; (operational stores and 

prime vendor); and (4) provides 

technical and staff assistance to Area 

and service units on matters related to 

the acquisition, utilization, disposition, 

and accountability of supplies. 

Division of Acquisition Management 

and Contracts (GFJ24) 

(1) Plans, develops, and coordinates 

the execution of administrative systems, 

methods, and techniques for Area 

procurement activities; (2) provides 

guidance to service units on the 

administrative aspects of Federal 

contracting, procurement, and grant 

requirements; (3) participates with 

Tribes in developing administrative 

structures, procedures, and skills related 

to contract, procurement, and grants 

management; (4) serves as the principle 

focus for liaison activities regarding the 

administrative aspects of procurements; 

intra and inter-agency agreements, 

collaborative agreements, memorandum 

of agreements (MOA) and memorandum 

of understanding (MOU), etc.; (5) 

determines and delegates procurement 

authority; and (6) administers the 

International Merchant Purchase 

Authorization Card (IMP AC) program. 

Business Policy Staff 

(1) Plans, develops, and coordinates 

the execution of administrative systems, 

methods, and techniques for both Area 

Office and service unit procurement 

activities; (2) audits in-progress and 

completed work of Area Office and 

service units; (3) prepares and issues 

internal and field policies and guidance; 

(4) provides acquisition support through 

cost/price analysis and proposal and bid 

evaluation; (5) serves as staff advisor/ 

auditor for Area Office on all service 

related acquisitions and other; (6) serves 

as NAIHS Ombudsman for development 

and fostering of contractual 

relationships; (7) reviews and processes 

other agreements, including intra and 

inter-agency agreements, collaborative 

agreements, MOA and MOU, etc.; (8) 

reviews and processes justifications for 

other than full and open competition; 

(9) reviews and processes ratifications; 

(10) assists in administration of the 

IMPAC program; and (11) reviews and 

processes protests. 

Small Purchase Staff 

(1) Awards and monitors procurement 

actions for supplies and services below 

the simplified acquisition threshold; (2) 

provides technical assistance to nonacquisition personnel in the 

Government and private sector; (3) 

ensures compliance with applicable 

Federal regulations and statutes; (4) 

prepares closeout documentation, 

reviews and processes claims, disputes, 

and termination actions; and (5) 

coordinates and prepares necessary 

acquisition reports. 

Contract Performance and Evaluation 

(GFJ24) 

Pre-Award: (1) Establishes quality 

assurance provisions and surveillance 

systems for supply and service 

contracts; (2) coordinates site visits for 

developing future contracts; (3) assists 

Project Officers in developing 

statements of work; (4) serves as a 

technical expert for performance-based 

service acquisitions; and (5) ensures 

independent Government cost estimates 

are supported by historical data or other 

factual information. 

Post Award: (1) Oversees contractual 

terms pertaining to quality assurance 

and quality control; (2) performs field 

inspections to ensure compliance with 

contractual terms; (3) evaluates 

contractor performance on a wide 

variety of contractual issues and 

obligations; (4) maintains contractor 

past performance databases; and (5) 

assists with administration of 

performance-based contracts (PBC) to 

ensure proper application of PBC 

deductions or incentives. 

General Acquisition Branch (GFJ242) 

(1) Awards and monitors formally 

advertised and negotiated contracts for 

supplies and services; (2) provides 

technical assistance to non-acquisition 

personnel in the Government and 

private sector; (3) ensures compliance 

with applicable Federal regulations and 

statutes; (4) prepares closeout 

documentation on all contracts, reviews 

and processes claims, disputes, and 

termination actions; (5) coordinates and 

prepares necessary acquisition reports; 

and (6) conducts on-site acquisition 

program reviews in accordance with 

current HHS standards. 

Medical Contracts and Other 

Agreements Branch (GFJ243) 

(1) Coordinates the award and 

administration of all formally advertised 

and negotiated medical contracts; (2) 

provides planning, direction, 

monitoring, and evaluation assistance to 

service units on procurement functions; 

(3) ensures compliance with applicable 

Federal regulations and statutes; (4) 

prepares closeout documentation on all 

contracts, review and process claims, 

disputes, and termination actions; and 

(5) evaluates and administers 

compliance and closeout of contracts. 

Division of Human Resources (GFJ25) 

(1) Provides the full range of 

personnel management and personnel 

administrative services including 

manpower planning and utilization, 

staffing, recruitment, compensation and 

classification, training, career 

development, labor and employee 

relations; (2) provides advice, 

consultation, and assistance to Navajo 

Area Office and service unit managers, 

and Tribal officials on personnel policy 

issues associated with the 

implementation of Pub. L. 93–638; (3) 

develops Area/Service Unit level 

training programs; and (4) represents 

NAIHS in personnel management 


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matters within and outside the Navajo 

Area. 

Public Law 93–638 Staff Support 

(1) Implements personnel servicing 

responsibilities for the Pub. L. 93–638 

human resources programs covered by 

the Area’s appointing authority; (2) 

processes personnel actions and 

appointing of all civil service and 

commissioned corps employees; (3) 

implements the application of the 

principles, practices and techniques of 

personnel recruitment, examination, 

selection and/or placement; and (4) 

advises management regarding merit 

promotion principles and various 

Federal personnel regulations, as well as 

Indian preference law/policies, basic 

personnel management concepts in 

determining career patterns, identifying 

promotional and reassignment 

opportunities. 

Staffing Branch (GFJ252) 

(1) Implements personnel servicing 

responsibilities for the NAIHS human 

resources programs covered by the 

Area’s appointing authority; (2) 

processes personnel actions and 

appointing of all civil service and 

commissioned corps employees; (3) 

implements the application of the 

principles, practices and techniques of 

personnel recruitment, examination, 

selection and/or placement; and (4) 

advises management regarding merit 

promotion principles and various 

Federal personnel regulations, as well as 

Indian preference law/policies, basic 

personnel management concepts in 

determining career patterns, identifying 

promotional and reassignment 

opportunities. 

Classification and Training Branch 

(GFJ253). 

Classification 

(1) Establishes and maintains the Area 

Position Classification Program assuring 

positions are classified according to 

Office of Personnel Management 

classification standards, techniques, and 

guides; (2) conducts regulatory 

classification reviews and provides 

technical guidance and assistance on 

special position reviews for service unit 

managers; and (3) provides advice to 

managers on position management 

techniques and practices. 

Training 

(1) Assesses organizational training 

needs; (2) conducts or coordinates 

training of Area/Service Unit staff; (3) 

manages clearances of training requests 

for the NAIHS and manages 

nominations for long-term training; (4) 

coordinates applications for Pub. L. 93–

437 scholarships and monitors student 

progress after scholarship award; and (5) 

evaluates training and career 

development activities throughout the 

Navajo Area. 

Employee, Labor Relations and Benefits 

Branch (GFJ254) 

(1) Provides guidance, consultation, 

and assistance to management and 

employees on employee relations 

matters (i.e., life insurance, health 

insurance, retirement, leave), on 

grievances and appeals, adverse actions, 

employee discipline, and related 

matters; (2) provides advice on 

employee performance plans, incentive 

awards; and (3) represents management 

in meetings with labor organizations, 

and before third-party officials. 

Division of Management Information 

Systems (GFJ26) 

(1) Provides direction, supervision 

and management of all activities related 

to data processing, word processing, 

networking, video-conferencing, digital 

imaging transmission, computer 

security, telecommunications and 

archiving; (2) provides direct services 

through operation and management of 

associated automated data processing 

(ADP) hardware and software; (3) 

provides technical assistance in related 

activities involving systems design, 

development, implementation, testing 

and training throughout the NAIHS, 

including staff assistance to Area and 

service unit staff; (4) provides data 

processing services, including computer 

operations, and information retrieval 

and analysis for operational data 

systems within the NAIHS; and (5) 

performs systems analysis, computer 

programming, computer systems 

security, system implementation and 

user training for the Area’s data systems. 

Systems Administration Branch 

(GFJ261) 

(1) Provides overall system 

administration support functions for the 

Navajo Area Office and service unit 

Resource and Patient Management 

System, NT, Win 2k, Unix and 

Commercial Off The Shelf operating 

systems; (2) plans, develops, and 

manages the NAIHS Web site; (3) 

monitors and ensures all Security 

requirements are met or exceeded; (4) 

develops applications for 

administrative, financial and clinical 

reporting requirements; and (5) 

evaluates new technologies and internet 

services. 

Policy Planning and Management 

Branch (GFJ262) 

(1) Coordinates and promotes the 

NAIHS information technology (IT) 

strategic planning initiatives; (2) 

monitors, develops and manages the 

NAIHS information systems policies 

and procedures; (3) consults with 

administrative services and 

management regarding information 

systems initiatives and provides IT 

support; (4) maintains, monitors and 

coordinates the RPMS system-wide data 

elements requirements; and (5) 

assembles performance improvement 

measurements required by the Joint 

Commission on Accreditation of 

Healthcare Organizations (JCAHO) or 

Centers for Medicare and Medicaid 

Services (CMS). 

Information Systems Security Branch 

(GFJ263) 

(1) Develops and monitors 

information systems security 

requirements for NAIHS; (2) plans, 

develops, and monitors security 

policies, procedures and requirements 

for the Area Office and service units; (3) 

installs, manages and monitors security 

systems to protect patient privacy and 

confidentiality; (4) plans, designs and 

implements network and 

telecommunications systems to provide 

optimum voice, video and data 

transmission; and (5) manages and 

monitors wide area network and local 

area networks for optimum digital 

imaging/telehealth utilization and 

availability. 

Office of Environmental Health and 

Engineering (GFJ3) 

(1) Establishes policies related to 

NAIHS health care and sanitation 

facilities planning, construction, 

operations, and maintenance; (2) 

provides leadership, guidance and 

coordination to the overall Navajo 

facilities management programs; (3) 

develops and coordinates program 

requirements for planning, design and 

evaluation of health care and sanitation 

facilities; (4) develops, coordinates, and 

evaluates technical standards, guides, 

plans and requirements for health care 

and sanitation facilities constructing 

requirements within the Navajo Area; 

(5) provides leadership, guidance, and 

coordination to the overall Area 

Biomedical Engineering Program, and 

the Occupational Health and Safety 

Management Programs; and (6) allocates 

appropriation funds to all Office of 

Environmental Health and Engineering 

programs and projects. 


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Division of Environmental Health 

Services (GFJ32) 

(1) Plans, develops and appraises 

Area-wide environmental health 

services programs; (2) provides 

technical assistance to the service units 

and the Tribes on the implementation of 

comprehensive environmental health 

programs and services among Indian 

families and communities; (3) provides 

technical assistance on environmental 

health including institutional 

environmental health and plan reviews, 

vector control, epidemiology, sanitary 

facilities, and food sanitation to the IHS, 

Tribes and other State and Federal 

agencies; (4) plans and implements an 

integrated Area-wide injury prevention 

and control program designed to reduce 

injury deaths and hospitalizations: (5) 

coordinates environmental responses to 

emerging diseases with Tribes, States, 

and other Federal agencies; and (6) 

manages and administers a Web-based 

environmental health database that 

helps determine resource requirement 

allocations. 

Division of Sanitation Facilities 

Construction Services (GFJ33) 

(1) Administers the Indian Sanitation 

Facilities Construction Program through 

Pub. L. 86–121; (2) plans, develops, 

coordinates, appraises and evaluates 

Area-wide sanitation facilities 

construction activities conducted in 

cooperation with Tribal groups and 

other agencies; (3) provides engineering 

consultation regarding environmentally 

related public health programs; and (4) 

provides technical liaison with other 

Governmental agencies, foundations 

and groups relative to public health 

engineering and environmental health. 

As part of the Pub. L. 86–121 program, 

the Division provides the following: 

• Personnel staffing, training, 

orientation, and development. 

• Professional/technical/ 

environmental standards compliance 

and support. 

• National Environmental Policy Act 

(NEP A) compliance documentation, 

approval, and support. 

• Right-of-way easement documents, 

approval, and support. 

• Specialty use/construction permits, 

approval, and support. 

• Project funding document 

preparation, production, approval, and 

support. 

• Multi-agency funded projects 

coordination, procurement, and task 

tracking. 

• Procurement/warehousing/ 

inventory of office and special order 

project materials/ equipment/services. 

• Project services, materials, 

equipment, and construction via 

MOA638 contracts with Navajo 

Engineering Consulting Association and 

Navajo Tribal Utility Association. 

• Vehicle fleet maintenance, 

management, and support. 

• Project electrical design, services, 

and support. 

• Project accounting and payment 

services and/or support. 

• Project final inspection/transfer 

process documentation, tracking, 

approval, and support. 

• Technical support for writing, 

completion, and distribution of project 

final reports. 

• Coordination of feasibility studies 

related to Tribal, chapter, and outside 

agency requests. 

Division of Facilities Management and 

Engineering (GFJ34) 

(1) Develops and coordinates program 

requirements for planning, design and 

evaluation of health care facilities in the 

Navajo Area; (2) develops, coordinates, 

and evaluates technical standards, 

guidelines, plans, and requirements for 

health care facilities construction 

requirements within IHS, HRSA and 

PHS; (3) develops and coordinates 

facility construction programs; (4) 

provides technical assistance and 

monitors Navajo Area and Tribal 

facilities planning and construction 

programs; (5) coordinates interagency 

requirements for shared or cooperative 

projects with agencies such as 

Department of Defense, Department of 

Veterans Affairs, State, Tribal, and 

regional planning bodies; (6) provides 

technical assistance and consultation to 

the Tribal government to assist and brief 

those organizations on the progress of 

planning, design and construction 

projects; (7) ensures compliance with 

NEP A and other environmental 

regulations in planning, design and 

construction of health care facilities, 

support buildings, major renovations/ 

expansion to existing facilities and staff 

quarters; (8) responsible for real 

property asset accountability of all IHS 

government property; and (9) 

responsible for budget accounting for all 

construction projects for all funding 

sources. 

Division of Biomedical Engineering 

(GFJ35) 

(1) Plans, develops, coordinates, 

appraises and evaluates Area-wide 

biomedical engineering programs; (2) 

assesses service unit biomedical 

engineering needs and develops 

appropriate action programs and 

modification to existing program 

functions; (3) coordinates staff 

assignments, designs medical 

equipment training and education 

programs for hospital and clinical staff 

and career development activities for 

the NAIHS; (4) provides engineering 

and technical assistance and 

consultation on biomedical engineering 

and telemedicine equipment, purchases, 

modifications, installation and hospital 

renovation and construction projects; (5) 

coordinates safety and emergency 

response planning activities; (6) ensures 

compliance with regulatory 

requirements and agencies imposed on 

IHS such as National Fire Protection 

Agency, Association for the 

Advancement of Medical 

Instrumentation, JCAHO, Food and Drug 

Administration, etc.; (7) coordinates the 

modification, installation and design of 

medical, dental, and radiology 

equipment; (8) assesses and minimizes 

the clinical and physical risk of 

equipment use on patients and clinical 

staff through equipment maintenance, 

inspection, testing and quality 

assurance and risk management 

programs; (9) supports direct patient 

care programs by maintaining and 

certifying the operation and safety of all 

medical equipment; (10) provides 

specialized biomedical engineering 

equipment repair for all dental, medical, 

and radiology equipment; (11) 

coordinates and monitors complex 

medical and laboratory contracts Areawide; (12) provides design and 

engineering of Picture Archiving and 

Communications System for radiology 

functions and recommends 

telemedicine applications for the 

applications for the clinical need and 

mission of IHS; and (13) specifies and 

designs telecommunications 

requirements for telemedicine to ensure 

sufficient bandwidth is available for the 

telemedicine programs. 

Division of Occupational Health and 

Safety Management (GFJ36) 

(1) Performs industrial hygiene 

activities including: Compliance 

surveys of radiographic equipment; 

assessment of radiation exposure to 

patients; quality assurance assessment 

of medical imaging processing; surveys 

of occupational exposure to nitrous 

oxide, ethylene oxide, anesthetic gases, 

mercury and other chemical hazards; 

evaluation of ventilation systems in 

negative pressure isolation rooms, 

operating rooms and dental operations; 

ergonomic analyses of workstations and 

high risk occupations; (2) coordinates 

safety and infection control program 

development and evaluation to include 

training and consultative assistance for 

safety officers and infection control 

practitioners; compliance reviews of 

existing policies and procedures; 

development of model policies and 


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procedures; safety and infection control 

program accreditation compliance 

reviews; occupational safety and 

infection control training for service 

unit staff; (3) coordinates environmental 

sampling to include sample collection 

and analysis of suspected asbestoscontaining materials; sample collection 

and analysis of suspected lead-based 

paint; quantification of indoor air 

contaminants; (4) conducts 

environmental assessments which 

include surveys to determine service 

unit compliance with Federal, State and 

local environmental regulations; and (5) 

develops and coordinates facilities 

management to conduct life safety code 

(building fire safety component) 

surveys; conduct construction plan 

reviews for new construction and 

renovation and consult with and 

advocate for facility managers on life 

safety code compliance issues. 

Office of Program Planning and 

Evaluation (GFJ4) 

Serves as the Area’s primary staff 

element and principal source of advice 

on program planning and evaluation 

activities to include: (1) Strategic 

planning coordination at the Area level, 

including planning, implementing, and 

monitoring progress on the achievement 

of the Area Strategic Plan; (2) facilities 

planning, including the development of 

program justification documents, 

program of requirements, quarters 

justifications, and other required 

facilities planning and construction 

documents; (3) staffing requirements 

and projections for service units, 

facilities projects, and other needs; (4) 

statistical and epidemiological 

reporting, analysis, and monitoring, and 

design/development to compile, 

analyze, report, and monitor health 

status, morbidity, mortality, patient 

care, health services, health systems, 

population, demographic, and other 

health related data for the Area, service 

units, Tribes, States, health programs, 

universities, researchers, and the 

general public and develop and 

implement data quality improvements 

and strategies; (5) resource allocation 

methodologies—updating and providing 

technical support for resource allocation 

to the OAD and the Navajo Area 

Management Council; (6) other program 

planning and health systems planning 

activities and technical support to the 

OAD—prepares briefings, issue papers, 

and other analyses for the OAD and 

assists local entities in health systems 

program development, implantation, 

and evaluation activities; (7) public 

affairs—coordinates media affairs and 

IRS clearance on media and 

publications; (8) urban coordination—

coordinates and serves as liaison 

between the local urban health program 

and the IRS HQ office and complying 

with requirements of the Indian Health 

Care Improvement Act provisions; (9) 

GPRA coordination—coordinates the 

implementation and reporting of 

Government Performance Results Act 

performance measurements in the Area; 

and (10) coordination of research and 

evaluation activities—including 

Institutional Review Board (IRB). 

Office of Health Programs (GFJ5) 

(1) Provides consultation and 

technical assistance to all operating and 

management levels of the NAIHS and 

Indian Tribes in the design and 

implementation of health management 

delivery system; (2) provides guidance 

and support to all field activities related 

to the day to day delivery of health care; 

(3) provides Area-wide leadership in 

health programs in relation to the IHS 

goals, objectives, policies, and priorities; 

(4) directs the development and 

implementation of health care 

administration and direct and contract 

health services, standards, quality 

control and quality assurance, 

operational planning activities and 

program reviews of health programs; 

and (5) provides leadership, guidance, 

and coordination of the health 

manpower and training programs. 

Division of Clinical Services and Health 

Promotion (GFJ52) 

(1) Provides direction for the 

operation of the health delivery 

activities of the NAIHS; (2) handles all 

logistics associated with the conduct of 

program reviews of service units; (3) 

advises on assessment findings for 

potential implications for NAIHS 

policy, plans, programs and operations; 

(4) develops quality of care evaluation 

criteria, standards of care, and guidance 

for the maintenance of the quality 

assurance programs of the NAIHS; and 

(5) conducts monitoring activities to 

assess the quality of care provided by 

the NAIHS. 

Behavioral Health 

(1) Plans, develops, and coordinates a 

comprehensive behavioral health 

program for the NAIHS in relation to 

stated goals and objectives and changing 

needs; (2) provides liaison with 

medical, alcohol, social services and 

other IHS disciplines regarding 

behavioral health issues; (3) provides 

technical consultation to Tribal and 

Urban groups and NAIHS staff; (4) 

coordinates and plans with service 

units, State, Federal, Tribal, 

professional, private and community 

organizations in identification, 

development and use of alternate 

resources for services; and (5) is a 

central source of information and 

communication on behavioral health 

needs and services within the NAIHS; 

(6) plans, directs, and evaluates the 

effective implementation of Service Unit 

Alcohol and Substance Abuse Services; 

(7) assures service unit and all contracts 

or grants for alcohoVsubstance abuse 

services are responsive to and based on 

an assessment of Indian community 

needs (that meet the physical, 

emotional, and spiritual needs of the 

service population with optimal use of 

available resources); and (8) coordinates 

services with other IHS and Federal 

agencies, State, Tribal and community 

programs. 

Dental Health and Performance 

Improvement 

(1) Develops, coordinates, and 

evaluates oral health programs; (2) 

establishes standards for staffing, 

technical procedures, use of facilities, 

and dental contracts; (3) coordinates 

professional recruitment, assignment 

and development for the Area; and (4) 

improves quality and efficiency of the 

Dental Program. 

Performance Improvement 

(1) Plans, develops and coordinates 

the Navajo Area Performance 

Improvement Program; 

(2) assists in the promotion and 

maintenance of the quality of patient 

care and staff training to assure the 

application of appropriate standards for 

health care provided; and 

(3) advises service units on matters 

pertaining to accreditation, quality 

assurance and performance 

improvement programs. 

Health Promotion Disease Prevention 

(1) Plans, coordinates, and integrates 

Health Promotion and Disease 

Prevention Services with other NAIHS 

programs and services; (2) promotes 

community and preventive health 

services to improve the health and well 

being of beneficiaries with optimal use 

of available resources; (3) provides 

Area-wide leadership in preventive 

health services in relation to IHS goals, 

objectives, policies, and priorities; and 

(4) coordinates the development and 

implementation of preventive health 

services, standards, quality control and 

quality assurance; operational planning 

activities and program reviews of 

preventive health programs. 

Health Informatics 

(1) Plans, coordinates and assists in 

implementation of new software/ 

hardware packages to support clinical 


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care. Assists in deployment of electronic 

health records and associated IT 

programs and systems will be an 

essential function; (2) provides a liaison 

function to promote communication and 

coordination between clinical staff, IT 

staff and administration; (3) analyzes 

and evaluates processes related to 

patient data flow, patient data quality 

and promotes changes for improved 

patient care; and (4) provides or 

acquires appropriate knowledge and 

training for both end users of clinical 

applications as well as IT and 

administrative staff. 

Diabetes and Other Chronic Diseases 

Branch (GFJ521) . 

(1) Provides medical staff and other 

health professional/paraprofessionals 

state-of-the-art clinical care and 

treatment disease management 

guidelines emphasizing a team 

approach and comprehensive care; (2) 

provides materials and information on 

patient and family diabetes education 

and nutritional counseling; (3) provides 

technical assistance to Tribal and 

community based programs; (4) 

provides cultural and literacy 

appropriate diabetes education 

materials to community members and to 

staff; (5) conducts annual diabetes 

medical chart audit at ITV facilities; (6) 

networks with other Area and National 

Diabetes Program staff; (7) serves as 

project officer for IHS HQ awarded 

diabetes grant programs; (8) responsible 

for success of and reports on GPRA 

elements regarding outcomes of care 

relating to diabetes; and (9) responsible 

for taking best practice models for 

prevention and treatment of chronic 

diseases other than diabetes and 

fostering their application in health care 

settings where care is provided by the 

NAIHS. 

Division of Nursing Services (GFJ54) 

(1) Works with service unit Directors 

of Nurses to determine standards, 

develop, monitor, and evaluate nursing 

care services for the NAIHS; (2) 

provides professional guidance to 

service units and formulates guides, 

policies, and procedures; (3) coordinates 

nursing recruitment, assignments, and 

career development for the Navajo Area; 

and (4) assesses NAIHS professional 

staffing needs and provides consultation 

and technical assistance in the initiation 

of Area training programs for ancillary 

personnel and continuing education of 

paraprofessional and professional 

nursing staff members. 

Hospital and Ambulatory Nursing 

(GFJ5) 

(1) Coordinates the development and 

evaluation of ambulatory care activities; 

(2) coordinates professional staff 

recruitment, assignments, and 

development opportunities; (3) develops 

and disseminates appropriate standards 

for quality assurance; (4) collaborates 

with national health organizations, 

other IHS Areas, and service unit staff 

to promote and improve ambulatory 

care services; (5) coordinates the 

development and evaluation of 

inpatient care activities; (6) coordinates 

professional staff recruitment, 

assignments, and development 

opportunities; and (7) develops and 

disseminates appropriate standards for 

quality assurance. 

Nurse Recruitment 

(1) Collaborates with NAIHS 

managers to assess nursing manpower 

needs; (2) assesses the professional 

staffing needs; and (3) coordinates 

activities with NAIHS and HQ staff to 

recruit, assign and retain nursing care 

professionals. 

Division of Professional Staff and 

Recruitment (GFJ55) 

(1) Develops the NAIHS program to 

recruit, assign and retain health care 

professionals; (2) assesse the 

professional staffing needs and 

coordinates the development of 

strategies to satisfy these needs, and to 

increase the morale and retention of all 

professionals; (3) provides liaison with 

commissioned corps activities; and (4) 

maintains contact with related 

professional societies, educational 

institutions, and other Federal, State 

and local agencies. 

Office of Indian Self-Determination 

(GFJ6) 

(1) Plans, coordinates and implements 

all tasks relative to contracting activities 

pursuant to the Indian SelfDetermination and Education 

Assistance Act, Pub. L. 93–638; (2) 

coordinates and effectuates respectful 

and positive relations with Tribal, State 

and Federal Governments and agencies, 

and intra-agency departments at local 

and national offices; (3) develops 

supportive relationships with local 

Tribal Governments and Tribal 

Organizations (contractors); (4) provides 

advice on the effect and impact of IHS 

policies, plans, programs and operations 

on Tribal operations and relationships; 

(5) advises on new methods and 

techniques for Indian community 

participation in, and management of 

their health programs; (6) provides 

technical assistance in such areas as 

financial resource management (inter/ 

intra-agency), health board and staff 

training; (7) organizes, collaborates, 

promotes and maintains effective Tribal 

consultation with NAIHS Health 

Boards, Tribal Government Programs, 

Tribal Organizations and Tribal Leaders; 

(8) coordinates activities with IHS HQ 

and NAIHS on relevant Tribal activities 

(9) coordinates, assists and monitors 

intergovernmental and legislative 

activity and functions; (10) monitors 

and provides liaison for the 

maintenance of an effective financial 

management system on all aspects of 

contract funding; (11) responsible for 

Contracting Officer’s functions as it 

relates to Pub. L. 93–638 contract 

functions for NAIHS including contract 

development, execution, administration, 

and maintenance of contract files; (12) 

assists, establishes and maintains 

effective contract administration service 

policies and procedures, regulations for 

all Tribal contracts and grants under 

Pub. L. 93–638; (13) advises and reports 

pertinent data/information to the Area 

Director, Executive Committee, Pub. L. 

93–638 Negotiation Team, service unit 

Chief Executive Officers, Tribal 

Governments, and Tribal Organizations 

relative to contracting activities; (14) 

compiles Area Director Report to Navajo 

Nation legislature on a quarterly basis; 

(15) collaborates with Area Program 

Offices, Pub. L. 93–638 contractors and 

IHS HQ on budget and program issues; 

(16) provides technical support to the 

Office of the General Counsel on Pub. L. 

93–638 issues; (17) provides technical 

assistance and conducts monthly 

meeting on reconciliation and related 

tasks; and (18) assists with all 

administrative tasks in the operation of 

all Office of Indian Self-Determination 

programs, functions, services and 

activities. 

Contracting Staff 

(1) Assists, establishes and maintains 

effective contract administration service 

policies and procedures, regulations for 

all Tribal contracts and grants under 

Pub. L. 93–638; and (2) advises service 

units and the Tribe on matters 

pertaining to contracting under Pub. L. 

93–638. 

Project Management Staff 

(1) Collaborates with Tribes and 

promotes effective Tribal consultation 

through liaison with NAIHS Health 

Boards, Tribal Government Programs, 

and Tribal Leaders; and (2) coordinates 

activities with NAIHS on all Tribal 

activities. 


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Finance and Budget Branch (GFJ61) 

(1) Provides liaison for the 

maintenance of an effective financial 

management system on all aspects of 

Title I contract funding; and (2) 

provides technical assistance and 

consultation to Tribal programs on 

financial matters. 

Navajo Area Office Service Units 

Navajo Area Indian Health Service is 

the primary health care provider on the 

Navajo Indian reservation. The goal of 

the NAIHS health program is to provide 

for, and improve upon, the efficient 

delivery of high quality, comprehensive 

health care to the Navajo people. 

Comprehensive health care is provided 

through inpatient, outpatient and 

community health (preventive) 

programs centered around 6 hospitals, 7 

health centers and 12 health stations 

and school clinics. The goal is to 

provide high quality, comprehensive 

preventive health care to the Navajo 

people, including prenatal care, 

immunizations, well-baby clinics, 

family planning, health education, and 

chronic disease follow-up. Service units 

in the NAIHS are as follows: 

Chinle Service Unit (GFJA); 

Crownpoint Service Unit (GFJB); Fort 

Defiance Service Unit (GFJC); Gallup 

Indian Medical Center (GFJD); Kayenta 

Service Unit (GFJE); Shiprock Service 

Unit (GFJJ). 

Dated: November 15, 2006. 

Robert G. McSwain, 

Deputy Director, Indian Health Service. 

[FR Doc. 06–9476 Filed 11–30–06; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB review; comment 

request; National Institute of Diabetes 

and Digestive and Kidney Diseases 

Information Clearinghouses Customer 

Satisfaction Survey 

SUMMARY: Under the provisions of 

section 3507(a) (1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute of Diabetes and Digestive and 

Kidney Diseases (NIDDK), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on August 14, 

2006, page 46486 and allowed 60-days 

for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Institutes of Health may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Proposed Collection 

Title: NIDDK Information 

Clearinghouses Customer Satisfaction 

Survey. 

Type of Information Requested: 

Revision of a previously approved 

collection for which approval has 

expired. The OMB control number 

0925–0480 will expire on November 30, 

2006. 

Need and Use of Information 

Collection: NIDDK is conducting a 

survey to assess the efficiency and 

effectiveness of services provided by 

NIDDK’s three clearinghouses: the 

National Diabetes Information 

Clearinghouse (NIDC); the National 

Digestive Diseases Information 

Clearinghouse (NDDIC); and the 

National Kidney and Urologic Diseases 

Information Clearinghouse (NKUDIC). 

The survey responds to Executive Order 

12821, ‘‘Setting Customer Service 

Standards,’’ which requires agencies 

and departments to identify and survey 

their ‘‘customers to determine the kind 

and quality of service they want and 

their level of satisfaction with existing 

services.’’

Frequency of Response: On occasion. 

Affected Public: Individuals or 

households; business and for profit 

organizations; not-for-profit agencies. 

Type of Respondents: Physicians, 

health care professionals, patients, 

family and friends of patients. 

The annual reporting burden is as 

follows: 

Estimated Number of Respondents: 

5,112. 

Estimated Number of Responses per 

Respondent: 1. 

Average Burden Hours per Response: 

0.025. 

Estimated Total Annual Burden 

Hours Requested: 128. 

The annualized costs to respondents 

is estimated at $6,400.00. There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

BURDEN TABLE

Number of 

respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

Average 

hourly 

wage rate 

Respondent 

cost 

5,112 .................................................................................... 1.00 0.025 128 $50.00 $6,400.00 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of the information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

reports and instrument, contact Kathy 

Kranzfelder, Project Officer, NIDDK 

Information Clearinghouses, NID, 

Building 31, Room 9A04, MSC2560, 

Bethesda, MD 20852, or e-mail your 

request, including your address to: 

kranzfeldk@hq.niddk.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 


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