45430 Federal Register / Vol. 72, No. 156 / Tuesday, August 14, 2007 / Notices 

screenings overall. Of particular interest 

are adults aged 40–70 years of various 

races and ethnicities who are at high 

risk for lung cancer (i.e., long-term 

heavy smokers). 

The proposed project will use focus 

groups to gather information about the 

target audiences’ experiences and 

practices related to lung cancer 

screening and testing. If warranted from 

focus group data with adult consumers, 

follow-up personal interviews will be 

conducted with selected focus group 

participants, especially those reporting 

experience with screening tests, such as 

spiral computed tomography (CT). 

A total of 16 focus groups will be 

conducted at professional focus group 

facilities with long term heavy smokers 

aged 40–70. The data will be collected 

from a convenience sample of adults 

who will be screened and recruited 

using lists maintained by the focus 

group facilities. Each focus group will 

include approximately nine participants 

and last two hours. If warranted, onehour telephone follow-up interviews 

will be conducted with up to 16 

participants within one month of the 

focus groups. 

Four telephone focus groups will be 

conducted with primary care 

physicians. The American Medical 

Association Physician Masterfile list 

will be used to recruit a random sample 

of physicians for participation in the 

focus groups. Potential participants 

(physicians) will be mailed a screening 

packet to complete and return. Each of 

the four focus groups will include 

approximately eight participants and 

last 75 minutes. 

There are no costs to respondents 

except their time to participate in the 

survey. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses/ 

respondent 

Average burden/response 

(in hours) 

Total burden 

(in hours) 

Patient Participants Screener .......................................................................... 288 1 2/60 10 

Patient Focus Group Participants .................................................................... 144 1 2 288 

Patient Follow-up Interview In Depth Participants ........................................... 16 1 1 16 

Physician Participants Screener ...................................................................... 96 1 5/60 8 

Physician Focus Group Participants ................................................................ 32 1 1.15 40 

Total .......................................................................................................... 362 ........................ ........................ 362 

Dated: August 8, 2007. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E7–15896 Filed 8–13–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Interagency Committee on Smoking 

and Health, National Center for 

Chronic Disease Prevention and Health 

Promotion 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting for the 

aforementioned committee: 

Time and Date: 11:30 a.m.–4:30 p.m., 

September 18, 2007. 

Place: Grand Hyatt Washington, 1000 

H. Street, NW., Burnham Room, 

Washington, DC 20001, Telephone: 

(202) 582–1234. 

Status: Open to the public, limited 

only by the space available. Those who 

wish to attend are encouraged to register 

with the contact person listed below. If 

you will require a sign language 

interpreter, or have other special needs, 

please notify the contact person by 4:30 

p.m., E.S.T. on September 7, 2007. 

Purpose: The Committee advises the 

Secretary, Department of Health and 

Human Services, and the Assistant 

Secretary for Health in the (a) 

coordination of all research and 

education programs and other activities 

within the Department and with other 

federal, state, local and private agencies 

and (b) establishment and maintenance 

of liaison with appropriate private 

entities, federal agencies, and state and 

local public health agencies with 

respect to smoking and health activities. 

Matters To Be Discussed: The agenda 

will focus on ‘‘Reducing Children’s 

Exposure to Second Hand Smoke.’’

Agenda items are subject to change as 

priorities dictate. 

Substantive program information as 

well as summaries of the meeting and 

roster of committee members may be 

obtained from the Internet at http:// 

www.cdc.gov/tobacco. 

Contact Person for More Information: 

Ms. Monica L. Swann, Management and 

Program Analyst, Office on Smoking 

and Health, CDC, 4770 Buford Highway, 

M/S K50, Atlanta, GA 30341, 

Telephone: (770) 488–5278. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Diane C. Allen, 

Acting Director, Management Analysis and 

Service Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–15873 Filed 8–13–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease control and 

Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 72 FR 38600—38601, 

dated July 13, 2007) is amended to 

reflect the reorganization of the 

Coordinating Office for Global Health, 

Centers for Disease Control and 

Prevention. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: Delete in their entirety the titles 

and functional statements for the 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 72, No. 156 / Tuesday, August 14, 2007 / Notices 45431 

Coordinating Office for Global Health 

(CW), and insert the following: 

Coordinating Office for Global Health 

(CW). The mission of the Coordinating 

Office for Global Health (COGH) is to 

work with partners in CDC and around 

the glove through technical assistance 

and health system development to 

promote improved health and health 

diplomacy, and protect citizens of the 

U.S. and the world. 

To carry out its mission, working with 

and through global programs, COGH: (1) 

Serves as the principal Centers for 

Disease Control and Prevention (CDC) 

organization to develop and foster 

collaborations, partnerships, program 

integration, and resource leveraging 

among public and private organizations 

and to increase the CDC’s global health 

impact in order to achieve global health 

goals; (2) coordinates review of current 

global health status and evolving issues; 

(3) provides strategic direction for CDC’s 

global health policies and programs; (4) 

identifies and develops activities to 

ensure CDC’s technical expertise is used 

to maximize global health impact; (5) 

stimulates global health research and 

program development based on 

assessments of current global health 

needs and available resources; (6) 

conducts and stimulates activities to 

strengthen global health capacity and 

systems through public health 

workforce, systems, and process 

development and improvements; (7) 

coordinates cross-cutting CDC global 

health activities and global health 

emergency response efforts; and (8) 

manages CDC global field operations 

through a system of regional and 

country directors. 

Office of the Director (CWA). (1) 

Manages, directs, and evaluates the 

activities of COGH; (2) provides 

leadership in the formulation and 

implementation of CDC’s global health 

strategies, policies, and goals; (3) 

advises the Director, CDC, on global 

health issues; (4) ensures coordination 

of the CDC response to global health 

emergencies; (5) leads the development 

of, and fosters strategic and working 

partnerships, in support of the global 

health goals; (6) coordinates CDC’s 

legislative agenda and activities related 

to global health; (7) provides leadership 

in determining requirements for CDC’s 

funding and staffing needs for global 

health programs; (8) manages the 

distribution of, and provides oversight 

for, CDC categorical global health 

program funding; (9) coordinates, in 

cooperation with the Office of Strategy 

and Innovation, the development, 

measurement, and assessment of 

progress toward CDC’s global health 

goals, efforts to improve global health 

equity, fostering of excellence and 

innovation, and executive decision 

support; (10) coordinates, in 

cooperation with Office of the Chief of 

Public Health Practice and the Office of 

the Chief Science Officer, CDC’s global 

health practice and science activities; 

(11) coordinates, in cooperation with 

the Office of Enterprise 

Communications, internal and external 

global health communications, media 

relations, issues management across 

CDC global programs, and develops and 

maintains the COGH intra-, extra-, and 

internet and web sites; (12) coordinates, 

in cooperation with the Office of 

Workforce and Career Development, 

efforts to ensure a competent and 

sustainable CDC and global health 

workforce through workforce and career 

development for CDC internationally 

assigned staff, both direct hires and 

locally employed staff, and assisting 

partner countries in their workforce and 

career development efforts; (13) 

convenes and supports the Global 

Health Leadership Board; (14) provides 

business services support for COGH and 

program services for global health 

programs; (15) develops and 

implements supplemental 

administrative policies and procedures 

that govern business administration, 

procurement practices, facilities 

management, time and attendance 

reporting, travel, records management, 

personnel and a wide scope of other 

business services; (16) plans, 

coordinates, tracks, and provides 

management advice and direction of 

fiscal management for the organization’s 

annual budgets and spend plans; (17) 

provides consultation on human capital 

needs and facilitates hiring and training 

practices as described in the Office of 

Personnel Management and agency 

guidelines; (18) coordinates and 

manages all business services related to 

management, administration, and 

training for COGH; (19) working with 

and through global programs, 

coordinates issues related to 

telecommunications, office space and 

design, physical security, procurement 

of equipment, furniture, IT services, and 

facilities management; (20) provides 

assistance in formulating, developing, 

negotiating, managing, and 

administering various COGH contracts; 

and (21) maintains liaison with the 

other offices within COGH and other 

business services offices within CDC. 

Global Program Services Office 

(CWA2). The mission of the Global 

Program Services Office (GPSO) is to 

support CDC-wide programs and staff 

through the efficient, professional and 

timely delivery of critical global health 

mission-support services. To carry out 

its mission, GPSO performs the 

following functions: (1) Provides 

agency-wide support for global travel 

services; (2) provides agency-wide 

leadership and support in ensuring 

consistency for global assignments, 

systems, and operations; (3) provides a 

point of contact for overseas staff for 

deployment support, services, and 

entitlements; (4) administers the CDC 

Exchange Visitors Program and is 

responsible for agency-wide 

immigration-related activities; (5) 

provides leadership, expertise and 

technical assistance to CDC programs 

regarding extramural and procurement 

transactional functions; (6) provides a 

liaison with the Department of State for 

embassy related issues; (7) provides a 

liaison with the information technology 

office, global program offices, and 

overseas offices to advocate and 

coordinate global technology and 

systems; and (8) consults regularly with 

CDC Programs on strategic and 

operational issues regarding missionsupport services provided by COGH–

GPSO through a Governance Council 

and Customer Feedback Forum. 

Global Operations Management Office 

(CWA23). (1) Advises the COGH 

Director and Chief Management Official 

on important issues related to 

assignments, systems, and operations 

for international activities impacting 

programmatic implementation; (2) 

services as the focal point for CDC 

services for international assignees; (3) 

coordinates the operational support 

services for CDC global programs; (4) 

coordinates development of policies for 

overseas services management, locally 

employed staff, and overseas travel; (5) 

coordinates and documents 

international services management 

policy agency-wide with the 

Department of Health and Human 

Services (DHHS) and with the 

Department of State (DOS), ascertaining 

the need for, and proposing 

administrative improvements and 

legislative requirements to improve 

operations and avoid management 

problems; (6) participates as a member 

of the government-wide working group 

for the interagency system for 

management of shared administrative 

support services (ICASS), overseas 

building operations and rightsizing 

liaison, capital security cost-sharing 

reconciliation, and property 

management (inventory, governmentowned vehicles, furniture, furnishings, 

appliances, equipment); (7) in carrying 

out the above responsibilities, 

coordinates activities with coordinating 

center/offices/implementing programs, 

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45432 Federal Register / Vol. 72, No. 156 / Tuesday, August 14, 2007 / Notices 

DHHS, Office of Global Health Affairs, 

other governmental and nongovernmental organizations, and other 

partners, as appropriate; (8) administers 

CDC Exchange Visitors Program and is 

responsible for agency-wide 

immigration-related activities; (9) 

coordinates processes for all overseas 

staff assignments including family 

support; (10) provided agency-wide 

passport, visa, and clearance services; 

(11) services as the CDC office 

responsible for obtaining DHHS and 

DOS clearances/approvals for all 

international TDY travel by CDC 

employees; (12) provides travel services 

to CDC employees traveling overseas 

including order issuance, country and 

DHHS clearances, as well as voucher 

preparation in support of the CDC global 

mission; (13) provides services to CDC 

employees stationed overseas who 

commence entitlement travel; (14) 

provides support and services to 

overseas assignees who are removed 

from their post for medical or security 

reasons; (15) provides reports to CDC 

programs regarding work volume, 

process timeliness, travel costs and 

customer satisfaction results; and (16) 

provides policy expertise to all 

employees performing international, 

entitlement or emergency travel. 

Extramural and Procurement Services 

Office (CWA24). (1) Working with and 

through global programs, provides 

support in the development and 

implementation of Funding Opportunity 

Announcements and Request for 

Financial Assistance; (2) as an extension 

of program, provides leadership in 

establishing and implementing the 

Objective Review Panel Process leading 

to funding determinations; (3) monitors 

and evaluate the business services 

components of recipient organizations 

achievement of goals and objectives; (4) 

manages the credit card processes for 

CDC programs with an overseas 

presence; (5) coordinates and approves 

individual international credit card 

transactions for CDC programs with an 

overseas presence; (6) manages the 

procurement processes from request to 

implementation; (7) participates in 

strategic planning development and 

implementation of CDC program 

support goals; and (8) provides routine 

and continuous feedback to recipients of 

Extramural and Program Support 

services and their managers regarding 

services provided. 

Division of Global Preparedness and 

Program Coordination (CWE). The 

Division of Global Preparedness and 

Program Coordination supports CDC 

global programs for global health 

preparedness and global health 

protection and promotion through 

leadership and coordination for global 

health programs. This includes agencylevel oversight for CDC’s system of 

international offices, and cross-cutting 

situational awareness for health status, 

program status, and partnership issues 

in all geographic regions of the world. 

To carry out its mission, the division 

performs the following functions: (1) 

Fosters collaborations, partnerships, 

integration, and resource leveraging to 

increase CDC’s impact and achieve 

global health goals; (2) manages and 

supports all CDC global health field 

operations using CDC Country Director 

or Country Representative structures 

where there are multiple CDC programs 

in a country; (3) provides, in 

cooperation and coordination with 

GPSO, support for all CDC global health 

field operations; (4) coordinates 

management and oversight of critical 

global health preparedness and 

emergency response activities across 

CDC, including situational awareness 

and partnership management at the 

global and regional level; (5) coordinates 

with and responds to requests from a 

wide array of internal CDC and external 

partners and stakeholders; and (6) 

provides stewardship and leadership 

support to global health preparedness 

programs housed in the division. 

Office of the Director (CWE1). (1) 

Provides leadership, oversight and 

overall direction for the activities of the 

division; (2) provides leadership and 

guidance on policy, program planning 

and evaluation, program management, 

and operations; (3) plans, allocates, and 

monitors resources; (4) provides 

leadership and management oversight in 

carrying out CDC global field programs; 

(5) provides liaison with other CDC 

organizations, other Federal agencies, 

national ministries of health, 

international organizations, nongovernmental organizations, private 

sector, and others with whom CDC 

cooperates in global health programs 

and activities; (6) in collaboration with 

the COGH Science Officer, and the 

Associate Directors of Science from the 

CDC global programs, promotes high 

standards in science and ethics among 

CDC’s international activities; and (7) in 

collaboration with the COGH Strategy 

and Innovation Officer, translates 

strategy and innovation concepts and 

initiatives out to the network of CDC 

international offices. 

Global Disease Detection and 

Emergency Response Branch (CWEB). 

The Global Disease Detection and 

Emergency Response Branch provides 

leadership and works with partners 

around the globe to increase 

preparedness to prevent and control 

naturally-occuring and man-made 

threats to health. Specifically, it: (1) 

Administers CDC’s Global Disease 

Detection program through coordination 

with relevant implementing programs; 

(2) coordinates global aspects of CDC’s 

terrorism preparedness and emergency 

response activities in collaboration with 

CDC’s Coordinating Office for Terrorism 

Preparedness and Emergency Response; 

(3) plans, supports, and coordinates 

international influenza pandemic 

preparedness in collaboration with 

relevant partners in CDC and DHHS; (4) 

provides leadership and support for the 

CDC global emergency preparedness 

and response program designed to 

prevent, if possible, and to prepare for, 

detect and respond to biological, 

chemical, radiological incidents, 

naturally occurring or man-made, of 

international interest; (5) works 

cooperatively with all CDC and U.S. 

government organizations involved in 

global emergency preparedness and 

response as well as with World Health 

Organization and other international 

organizations and partner countries; (6) 

assists in developing country-level 

epidemiologic, laboratory, and other 

capacity to ensure country emergency 

preparedness and response to outbreaks 

and incidents of local importance and of 

international interest; and (7) maintains 

staff in the Director’s Emergency 

Operations Center to serve as a central 

focus for CDC’s global outbreak/incident 

response activities. 

Geographic and Program 

Coordination Branch (CWEC). (1) 

Directs and manages human and 

financial resources in consolidated CDC 

country offices; (2) provides leadership, 

support and coordination for the 

agency-wide responsibilities of CDC 

country offices; (3) provides core 

support and coordination to CDC 

country offices through regional liaison 

teams, in cooperation with the GPSO; 

(4) facilitates new opportunities for 

international activities of the national 

centers’ programs, and provides 

technical and management support for 

existing activities; (5) promotes 

partnerships and coordination in 

strategic areas with key country, 

regional, international and U.S. 

Government institutions; (6) provides 

leadership on cross-cutting global health 

issues; and (7) coordinates countrybased assessments, planning and 

performance monitoring and evaluation. 

Division of Global Public Health 

Capacity Development (CWF). The 

Division of Global Public Health 

Capacity Development contributes to 

improving the health of the people of 

the United States and other nations by 

partnering with ministries of health, 

educational institutions, Federal 

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Federal Register / Vol. 72, No. 156 / Tuesday, August 14, 2007 / Notices 45433 

agencies, and international 

organizations to strengthen capacity of 

countries around the world to improve 

public health. To carry out its mission, 

the division performs the following 

functions: (1) Works with partners to 

build strong, transparent, and sustained 

public health systems through training, 

consultation, capacity building, and 

technical assistance in applied 

epidemiology, public health 

surveillance, evaluation, and laboratory 

systems; and promotes organizational 

excellence in public health through 

strengthening leadership and 

management capacity; (2) assists in 

developing and implementing COGH 

policy on public health system 

strengthening and sustainability; and (3) 

collaborates with other ODC 

organizations, Federal agencies, 

international agencies, partner 

countries, and non-governmental 

organizations assisting ministries of 

health to build public health capacity in 

other areas of public health. 

Office of the Director (CWF1). (1) 

Provides leadership, overall direction, 

and evaluation for the division; (2) 

formulates and implements CDC’s 

strategy for developing global public 

health capacity in applied 

epidemiology, public health systems, 

laboratory operations and management, 

and leadership; (3) provides leadership 

and guidance on policy, program 

planning, program management, and 

operations; (4) plans, allocates, and 

monitors resources; (5) provides 

leadership in assisting national 

ministries of health, international 

agencies, and non-governmental 

organizations in the delivery of 

epidemiologic services and the 

development of international 

epidemiologic networks; (6) provides 

liaison with other CDC organizations, 

other Federal agencies, national 

ministries of health, and international 

organizations; and (7) provides 

consultations with partners and 

stakeholders including 

nongovernmental organizations and the 

private sector on program development 

and overall public health systems and 

sub-systems. 

Sustainable Management 

Development Program (CWF12). (1) 

Partners with ministries of health, 

educational institutions, and nongovernmental organizations in 

developing countries, to promote 

organizational excellence in public 

health through strengthening leadership 

and management capacity; (2) works 

with partners to build capacity for 

public health leadership and 

management development through a 

multi-phased approach including 

situational analysis, capacity 

development, technical assistance, and 

sustainability; (3) develops strategic 

institutional partnerships for public 

health leadership and management 

capacity-building efforts; (4) develops 

faculty to enhance in-country leadership 

and management training capacity 

through the Management for 

International Public Health course and 

in-country training-of-trainers; (5) 

provides support to training faculty in 

partner institutions to conduct 

performance needs assessments; 

develops locally appropriate curricula; 

and designs in-country leadership and 

management workshops that provide 

participants with practical skills needed 

to manage public health teams, 

programs, and organizations; and (6) 

works with partner institutions to 

ensure the long-term sustainability of 

global public health leadership and 

management development programs. 

Capacity Development Branch 

(CWFB). (1) With partners, designs and 

conducts evidence-based instruction in 

public health disciplines needed to 

strengthen their public health systems, 

including instructional design, 

epidemiology, surveillance, laboratory 

operations and management, 

communications, and economic 

evaluation; (2) working with the 

technical program components, 

provides consultation to ministries of 

health in development of surveillance 

systems (e.g. Integrated Disease 

Surveillance, injury, chronic diseases, 

infectious diseases, etc.); (3) creates and 

maintains computer-based and distancebased learning methods, and develops 

the capacity of partners to create, 

evaluate, and share their own; (4) 

develops and evaluates competencybased training materials; (5) maintains a 

divisional training material library and 

Web site; and (6) collaborates within 

CDC and with national or international 

organizations in development of 

competency-based training materials, 

evaluation of training, and design of 

surveillance systems needed to 

accomplish the mission. 

Program Development Branch 

(CWFC). (1) Assists partners in assessing 

their needs for health systems 

strengthening; (2) plans, directs, 

supports, and coordinates field 

epidemiology and laboratory training 

programs, Data for Decision Making 

Projects, and other partnerships with 

ministries of health; (3) provides 

leadership and management oversight in 

assisting ministries of health in capacity 

building by training epidemiologists 

and other health professionals through 

the development of competency-based, 

residency-style, applied training 

programs; (4) provides leadership and 

expertise in assisting national ministries 

of health to utilize trained public health 

workers for developing health policy, 

and implementing and evaluating health 

programs; (5) assigns and manages 

expert consultants as long-term, incountry advisors to ministry of health 

programs; and (6) collaborates within 

CDC, with other Federal agencies, and 

with national and international 

organizations in support of partner 

programs. 

Dated: August 3, 2007. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 07–3953 Filed 8–13–07; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 1998D–0077 (formerly 98D–

0077)] 

Clinical Development Programs for 

Human Drugs, Biological Products, 

and Medical Devices for the Treatment 

and Prevention of Osteoarthritis; 

Request for Assistance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) seeks additional 

information on issues related to clinical 

development programs for human 

drugs, biological products, and medical 

devices for the treatment and prevention 

of osteoarthritis (OA). We will take such 

information into account as we work to 

finalize our draft guidance issued in 

July 1999. Once finalized, the guidance 

will aid sponsors and other interested 

parties in developing new products to 

treat OA. 

Before the agency can issue such 

guidance, a critical appraisal of certain 

fundamentals of the science related to 

OA is needed. FDA is inviting any 

interested party, or parties, to conduct 

and manage the coordination of this 

critical appraisal. FDA believes that the 

party, or parties’, first step in 

conducting the critical appraisal would 

be to hold a public meeting to discuss 

issues related to OA assessment and 

trial design. FDA intends to submit to 

the docket all the information received 

in response to this notice so that 

interested parties may be fully informed 

and to facilitate participation in and 

coordination of these activities. 

mstockstill on PROD1PC66 with NOTICES