51474 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices

sites to elicit interest by community

members in serving on the Community/

Tribal Subcommittee. From responses to

these efforts and to this Federal Register

notice, a pool of applicants will be

obtained from which the Planning

Committee will recommend a slate of

candidates. The BSC will then select the

nine community representatives of the

Community/Tribal Subcommittee from

the pool, with special consideration

given to the recommended slate.

Accordingly, any person who lives in a

community affected by an NPL or other

hazardous waste site, or is a

representative of a group that works at

local, regional, or national locations

with these communities, who wishes to

be considered for serving on this

Subcommittee should write to Triangle

Associates, Inc. at the address above to

express their interest and obtain

additional information.

Dated: September 25, 1997.

Georgi Jones,

Director, Office of Policy and External Affairs,

Agency for Toxic Substances and Disease

Registry.

[FR Doc. 97–25968 Filed 9–30–97; 8:45 am]

BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

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 62 FR 46751, dated

September 4, 1997) is amended to

reflect the reorganization of the

Epidemiology Program Office (EPO) as

follows: revise the functional statement

for the EPO to more accurately reflect

the mission of the office; establish the

Office of Program Management and

Operations; revise the functional

statement for the Scientific Information

and Communications Program and

retitle as the Office of Scientific and

Health Communications; revise the

functional statement for the Division of

Surveillance and Epidemiology and

retitle as Division of Public Health

Surveillance and Informatics; revise the

functional statement for the Division of

Training and retitle as the Division of

Applied Public Health Training;

establish the Division of Prevention

Research and Analytic Methods;

establish the Division of International

Health; abolish the Division of Field

Epidemiology.

Section C–B, Organization and

Functions, is hereby amended as

follows:

Delete the functional statement for the

Epidemiology Program Office (EPO)

(CB) and insert the following:

(1) Plans, directs, and manages CDCwide training and service programs,

including the Epidemic Intelligence

Service (EIS), the Preventive Medicine

Residency (PMR), and the Public Health

Program Specialist (PHPS) programs, as

well as various internship and

fellowship programs; (2) plans,

develops, edits, publishes and

disseminates the Morbidity and

Mortality Weekly Report (MMWR),

related publications, and various

scientific and health communication

documents and special reports; (3)

serves as a focal point for the

development of innovative methods for

the collection, analysis, and

communication of public health

surveillance information (e.g. National

Electronic Telecommunications System

for Surveillance, 122 Cities Mortality

Reporting System, and CDC WONDER);

(4) in collaboration with other Centers,

Institutes, and Offices (CIOs) and state

health departments, coordinates,

develops, implements, and supports

various public health information

systems for agency application; (5)

provides consultation, technical

assistance, and training on

epidemiology, public health

surveillance and informatics, health

information systems, prevention

effectiveness, scientific

communications, behavioral science,

statics, and development of community

health practice guidelines to CDC/

ATSDR, states, other agencies, other

countries, and domestic and

international organizations; (6) provides

policy and staff support for CDC’s

Health Information and Surveillance

Systems Board; (7) provides

epidemiologic assistance and epidemic

aid through the field assignment of

epidemiologists; (8) provides liaison

with governmental agencies,

international organizations, the Council

of State and Territorial Epidemiologists,

and other outside groups; (9) plans

conducts, and evaluates research

activities in various aspects of disease

and injury control for global programs;

(10) promotes the development of

international field epidemiologic

training programs; (11) develops,

promotes, and implements programs for

international and domestic data policy

formation for decision makers to

identify information needs and to use

information for improved decision

making; (12) in carrying out the above

functions, collaborates, as appropriate,

with the CDC Office of the Director,

other CDC CIOs, domestic and

international agencies and

organizations.

Delete the functional statement for the

Office of the Director (CB1) and insert

the following:

(1) Manages, directs, coordinates, and

evaluates the activities of EPO; (2)

develops goals and objectives and

provides leadership, policy formation,

scientific oversight, and guidance in

program planning and development; (3)

coordinates EPO program activities with

other CDC components, other PHS

agencies, other federal agencies, other

international organizations, state and

local health departments, communitybased organizations, business, and

industry; (4) consults and coordinates

activities with medical, scientific and

other professional organizations

interested in epidemiology, public

health surveillance and informatics,

health information systems, behavioral

science, statistics, scientific

communications, community health

practice guidelines, prevention

effectiveness, and training activities; (5)

ensures quality of scientific products of

EPO staff and adherence to ethical

principles and guidelines as specified in

Department of Health and Human

Services (DHHS) policy statements; (6)

coordinates technical assistance to

states, other nations and international

organizations; (7) advises the Director,

CDC, on policy matters concerning EPO

activities.

Delete the title and functional

statement for the Scientic information

and Communications Program (CB12)

and insert the following:

Office of Scientific and Health

Communications (CB12). (1) Plans,

coordinates, edits, and produces the

MMWR series and various special

reports and publications; (2) provides

editorial services and support to EPO;

(3) develops, implements, and evaluates

innovative methods for the

communication of scientific and health

information by EPO and its domestic

and international constituents; (4)

assists EPO and its constituents in

identifying and building needed

expertise, state-of-the-art technology,

logistical support, and other capabilities

required to conduct effective scientific

and health communication in domestic

and international settings; (5) provides

expert consultation and training to EPO,

other CIOs, and outside domestic and
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices 51475

international constituencies on

development of effective messages,

materials, and methods to clearly and

effectively communicate risks and

prevention recommendation, including

written, oral, and visual

communication; (6) provides leadership,

coordination, and collaboration for the

planning and management of EPO

communications with other CDC

programs and outside organizations in

scientific and health communication,

including serving as the primary EPO

liaison with the CDC Office of

Communication; (7) works closely with

state and federal agencies and EPO

domestic and international constituents

to develop health information networks

and to promote information sharing; (8)

in conjunction with the CDC Office of

Communication, collaborates with

organization in the public and private

sectors to market prevention strategies;

(9) coordinates EPO’s informationsharing activities, including

involvement on the Internet.

Delete the functional statement for the

Office of the Director (CB12) and insert

the following:

(1) Provides leadership and overall

direction for the Office of Scientific and

Health Communications and for all EPO

scientific and health communication

application; (2) provides leadership,

guidance, consultation, and training on

policy, planning, management, and

operations of scientific and health

communications for EPO activities in

domestic and international settings; (3)

establishes office goals, objectives, and

priorities; (4) monitors progress in

implementation of projects and

achievement of objectives; (5) provides

technical information and support in

scientific and health communication

methods to the epidemiologic,

surveillance, and other scientific

services and applied research activities

in EPO; (6) provides EPO-wide graphics

support and coordinates major scientific

and health communications efforts; (7)

plans, coordinates, and provides

support for the electronic dissemination

of the MMWR series.

Delete the title and functional

statement for the MMWR Branch

(CB122) and insert the following:

Morbidity and Mortality Weekly

Report Activity (CB122). (1) Develops,

plans, coordinates, edits, and produces

the weekly component of the MMWR

series; (2) participates with other office

personnel for the delivery of services

and training to external organizations,

both domestic and international, in the

area of scientific and health

communications; (3) provides EPO-wide

desktop publishing support, including

the support of the MMWR series.

Delete the title and functional

statement for the Public Health

Publications Branch (CB123) and insert

the following:

Public Health Publications Activity

(CB123): (1) Develops, plans,

coordinates, edits, and produces other

components of the MMWR series,

including the MMWR

Recommendations and Reports, CDC

Surveillance Summaries, and the

Annual Summary of Notifiable Diseases;

(2) plans, coordinates, edits, and

produces other EPO and CDC program

publications; (3) provides editorial

services for work to be published

outside CDC; (4) reviews EPO

documents for editorial clearance for all

publications; (5) develops and manages

an internship program in scientific and

health publications management; (6)

participates with other office personnel

for the delivery of services and training

to external organizations, both domestic

and international, in scientific and

health communications.

Delete in their entirety the title and

functional statement for the Information

Resources Management Branch (CB124)

and insert the following:

Office of Program Management and

Operations (CB12). (1) Provides

leadership, oversight, and guidance in

the management and operations of

EPO’s programs; (2) plans, coordinates,

and provides administrative

management support, advice, and

guidance to EPO; (3) conducts EPO

planning and evaluation activities; (4)

reviews, prepares, and coordinates

legislation, congressional testimony,

and briefing documents; (5) coordinates

the development of the EPO annual

budget submission; (6) coordinates the

annual EPO program briefing; (7)

conducts management analyses of EPO

programs and staff to ensure optimal

utilization of resources and

accomplishment of program objectives;

(8) plans, allocates, and monitors EPO

resources; (9) maintains liaison and

collaborates with other CDC

components and external organizations

in support of EPO management and

operations; (10) plans, coordinates, and

provides information resource

management support, advice, and

guidance to EPO.

Office of the Director (CB131). (1)

Directs and coordinates the activities of

the office; (2) develops long-range plans,

sets annual objectives, monitors

progress, and evaluates results; (3) sets

policies and procedures; (4) provides

leadership and oversight of EPO’s

program management and operations;

(5) plans, allocates, and monitors EPOwide resources; (6) maintains liaison

and collaborates with the Director,

Office of Program Support, other CIOs,

CDC staff offices, other federal agencies,

state and local health agencies, and

other external organizations; (7)

maintains liaison, on behalf of EPO,

with the CDC Foundation and other

similar organizations for the

coordination of mutually-beneficial

collaborative activities; (8) within the

policies and guidelines of DHHS and

CDC, conducts EPO planning and

evaluation activities including tracking

program objectives and performing

evaluation studies; (9) coordinates the

development of the EPO annual budget

submission; (10) coordinates the annual

EPO program briefing, including

preparation of all written and visual

materials; (11) reviews, prepares, and

coordinates legislation, congressional

testimony, and briefing materials;

develops proposed legislation; analyzes

bills; and provides for other legislativerelated activities; (12) plans and

prepares EPO promotional and

marketing materials; (13) works closely

with other federal agencies involved

with EPO interagency agreements; (14)

coordinates EPO requirements relating

to procurement, materiel management,

and interagency agreements; (15)

provides fiscal management and

stewardship of grants, contracts, and

cooperative agreements.

Information Resources Management

Activity (CB132). (1) Provides technical

information support to the

communications, epidemiologic,

surveillance, training, and prevention

research activities of EPO; (2) manages

the EPO Local Area Network (LAN); (3)

assists users with network applications;

(4) provides personal computer support

for EPO users; (5) researches and

performs appropriate testing and

installation of new software for use in

EPO; (6) coordinates and authorizes

requests for the acquisition of automatic

data processing, word processing,

telecommunication, and LAN

equipment, and the provision of

information services; (7) provides

interface with CDC and DHHS

management systems; (8) assures that all

functional groups within EPO have

access to suitable and compatible

equipment and services; (9) plans,

coordinates, and provides EPO-wide

Information Resources Management

(IRM) support and services; (10)

represents EPO on a variety of IRM

committees, task forces, and

workgroups; (11) coordinates the

utilization of data information systems

and technologies.

Management Services Activity

(CB133). (1) Plans, coordinates, and

provides administrative management

support, advice, and guidance to EPO
51476 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices

involving the areas of fiscal

management, personnel, travel, and

other administrative services; (2)

prepares annual budget plans and

budget justifications; (3) coordinates

EPO requirements relating to contracts,

grants, cooperative agreements, and

reimbursable agreements; (4) develops

and implements administrative policies,

procedures, and operations, as

appropriate for EPO, and prepares

special reports and studies, as required,

in the administrative management areas;

(5) conducts management analyses of

EPO programs and resources to ensure

optimal utilization of resources and

accomplishment of program objectives.

Delete in its entirety the title and

functional statements for the Division of

Field Epidemiology (CB3).

Delete the title and functional

statement for the Division of

Surveillance and Epidemiology (CB5)

and insert the following:

Division of Public Health Surveillance

and Informatics (CB5). (1) Collects,

performs analyses, and disseminates

public health surveillance information;

(2) manages and operates the National

Electronic Telecommunications System

for Surveillance (NETSS), the National

Notifiable Diseases Surveillance System

(NNDSS), and the 122 Cities Mortality

Reporting System and produces

statistical tables and graphics for the

MMWR and associated publications; (3)

in collaboration with other CIOs and

state health departments, coordinates,

develops, implements, and supports

various CDC-wide public health

information systems, including

informational and communications

applications; (4) develops improved

surveillance and informatics methods;

(5) provides consultation, technical

assistance, and training on public health

surveillance and health information

systems to CDC and to other agencies

and domestic and international

organizations; (6) coordinates activities

of the CDC Surveillance Coordination

Group; (7) provides policy and staff

support for CDC’s Health Information

and Surveillance Systems Board; (8)

coordinates a CDC-wide initiative aimed

at building state and local capacity to

perform the core public health function

of assessment and use of data for policy

development and assurance.

Delete the functional statement for the

Office of the Director (CB51) and insert

the following:

(1) Provides leadership and overall

direction for the division; (2) provides

leadership and guidance on policy,

program planning, program

management, and operations; (3)

establishes division goals, objectives,

and priorities; (4) monitors progress in

implementation of projects and

achievements of objectives; (5) provides

management, administrative, and

support services, and coordinates with

appropriate EPO offices on program and

administrative matters; (6) provides

liaison with other CDC organizations,

other governmental agencies,

international organizations, the Council

of State and Territorial Epidemiologists,

and other constituent groups and

partners; (7) plans, allocates, and

monitors resources; (8) provides

scientific leadership and guidance to the

division to assure highest scientific

quality and ethical standards; (9) plans

and coordinates the activities of the

CDC Surveillance Coordination Group;

(10) provides guidance and supervision

to EIS officers and Preventive Medicine

Residents assigned to the division; (11)

coordinates and serves as a focal point

for a CDC-wide initiative aimed at

building state and local capacity to

perform the core health function of

assessment and use of data for public

health policy development and

assurance.

Delete in their entirety the title and

functional statement for the Statistics

and Epidemiology Branch (CB52) and

insert the following:

Public Health Information Systems

Branch (CB53). (1) In collaboration with

the Information Resources Management

Office (IRMO) and other CDC

organizations with subject matter

expertise and responsibility,

coordinates, designs, develops,

implements, and supports CDC-wide

public health, epidemiologic, scientific,

and laboratory information systems,

including database, informational, and

communications applications (e.g., CDC

WONDER); (2) collaborates with CDC

organizations to jointly develop, test,

and implement CDC-wide public health

information systems; (3) participates in

the development or implementation of

CDC plans for public health information

systems; (4) researches and develops

new an innovative approaches to public

health applications development and

database design; (5) determines

appropriate technology architecture and

methodology for branch-developed

systems; (6) maintains inventories and

data dictionaries of CDC’s public health

data; (7) develops and recommends

approaches for public health systems

and interfaces between various

information technologies for sharing

data and performing cooperative

applications processing; (8) in

consultation with CDC organizations

and the CDC Information Systems

Security Officer, determines appropriate

security measures for branch-developed

databases and applications, in

accordance with sensitivity and

criticality of the data or system; (9)

evaluates and recommends CDC-wide

equipment and software acquisition for

public health database and

communications systems; (10)

coordinates the provision of technical

support and training in the use of CDCwide public health information systems

purchased or developed by the branch;

(11) coordinates public health

information resource management user

groups.

Delete in their entirety the title and

functional statement for the Systems

Development and Support Branch

(CB58).

Delete the functional statement for the

Systems Operation and Information

Branch (CB59) and insert the following:

(1) Operates and maintains the

NETSS, the NNDSS, and the 122 Cities

Mortality Reporting System; (2)

provides service and support to other

CDC programs and state and local health

departments to enable program-specific

surveillance information to be collected

and disseminated through the NETSS;

(3) provides support, technical

assistance, consultation, and training on

surveillance system development,

maintenance, and operation for CDC,

states, and international organizations;

(4) provides leadership and direction in

the development of mainframe systems

for use in surveillance and

epidemiology; (5) plans, coordinates,

and produces tables, graphs, maps, and

figures for the Annual MMWR Summary

of Notifiable Diseases, U.S.; (6) produces

MMWR tables from NNDSS; (7) plans,

coordinates and develops training and

educational materials for all

surveillance systems operated by the

branch; (8) provides guidance in the

development, implementation, and

analysis of electronic public health data

to international, state, and local groups;

(9) creates, disseminates, and archives

historical public health data in an

electronic form; (10) provides support,

technical assistance, and training for

new, developmental systems and

software for use in surveillance and

epidemiology; (11) provides support,

technical assistance, consultation, and

training on computerized surveillance

system development, maintenance, and

operation for CDC, states, and

international organizations; (12)

provides service and support in the

expansion of the NETSS; (13) plans and

coordinates state-supported activities

related to the NETSS; (14) analyzes

needs and designs computer systems for

use by public health professionals in the

effective practice of public health

surveillance and epidemiology; (15)

provides technical consultation for
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices 51477

activities of the CDC Surveillance

Coordination Group.

Delete the title and functional

statement for the Division of Training

(CB6) and insert the following:

Division of Applied Public Health

Training (CB6). Plans, directs, and

manages a CDC-wide training and

service program for the teaching and

training of public health professionals

in applied epidemiology and other

public health sciences, preventive

medicine, and public health program

planning, implementation, and

evaluation; (2) plans, directs, and

manages CDC-wide training and service

programs for the EIS, the PMR, and the

PHPS Programs; (3) responds to

domestic and international request for

assistance and consultation; (4)

maintains liaison with other

governmental agencies, academic

institutions and organizations, state and

local health agencies, private health

organizations, and professional

organizations, and other outside groups;

(5) assumes an active national and

international leadership role in public

health training.

Delete the functional statement for the

Office of the Director (CB61) and insert

the following:

(1) Provides leadership, direction,

coordination, and management

oversight to the activities of the

division; (2) develops long-range plans,

sets annual objectives, monitors

progress, and evaluates results; (3) sets

policies and procedures; (4) plans,

allocates, and monitors resources; (5)

provides administrative guidance and

oversight in the areas of personnel,

travel, and other administrative

services, and coordinates with the EPO

Office of Program Management and

Operations, Human Resources

Management Office, and Financial

Management Office; (6) coordinates

collaborative activities of the division

and maintains liaison with other CIOs,

other federal agencies, and other outside

groups.

Delete in their entirety the title and

functional statement for the

Epidemiolgy Training Activity (CB62).

Delete the title and functional

statement for the Epidemic Intelligence

Service Program (CB63) and insert the

following:

Epidemic Intelligence Service Branch

(CB63). (1) Establishes overall policies,

plans, and procedures, and evaluates

the effectiveness of program activities;

(2) develops and maintains a strategic

plans for recruitment, analyzes data to

more effectively target recruitment

efforts, and conducts recruitment in

accordance with the CDC workforce

diversity goals; (3) plans, directs, and

coordinates the application, interview,

selection. and assignment processes for

new EIS officers (4) plans, directs,

coordinates, and conducts training and

training activities for EIS officers in

applied epidemiology and public health

practice; (5) monitors the completion of

program requirements by EIS officers;

(6) maintains liaison with supervisors of

EIS officers, and evaluates EIS

assignments within CDC, state and local

health agencies, and other sponsoring

organizations; (7) approves request, for

epidemiologic assistance (EPI–AIDs)

and the expenditures of funds; (8)

maintains liaison with alumni within

and outside CDC to assist with

recruitment and promotional activities;

(9) plans, directs, and coordinates the

Epidemiologic Elective Program for

medical and veterinary students.

Delete in their entirety the title and

functional statement for the Preventive

Medicine Residency Program (CB64)

and insert the following:

Public Health Prevention Service

Branch (CB65). (1) Establishes overall

policies, plans, and procedures, and

evaluates the effectiveness of program

activities; (2) develops and maintains a

strategic plan for recruitment, analyzes

data to more effectively target

recruitment effort, and conducts

recruitment in accordance with the CDC

workforce diversity goals; (3) plans,

directs, and coordinates the application,

interview, selection, and assisgnment

processes for new PHPS trainees; (4)

plans, directs, coordinates, and

conducts training and training activities

for PHPS trainees in the development,

implementation, and evaluation of

prevention programs and interventions;

(5) monitors the completion of program

requirements by PHPS trainees; (6)

maintains liaison with supervisors of

PHPS trainees, and evaluates PHPS

assignments within CDC, state and local

health agencies, and other sponsoring

organizations; (7) coordinates and

provides staff support to a steering

committee/advisory group charged with

advising on policy matters concerning

the program.

State Branch (CB66). (1) Provides

guidance and supervision to EIS

officers, PMRs, and career

epidemiologists assigned to state and

local health departments; (2) monitors

and evaluates the quality of assignments

through site visits and by maintaining

liaison with supervisors and other

individuals in CIOs and states; (3)

monitors the completion of program

requirements and evaluates the

performance of state-based EIS officers;

(4) serves as the focal point for

assistance requests from state health

departments; (5) coordinates field

training activities (6) participates in

recruitment, interviewing, and

assignment activities of EIS officers; (7)

provides on-site consultation with state

and local health departments on the

establishment and maintenance of

epidemiology programs; (8) provides

technical assistance to other

components of CDC in the investigation

of multi-state disease outbreaks; (9)

coordinates liaison activities with state

epidemiologists and other public health

officials, (10) evaluates the effectiveness

of branch activities.

Division of Prevention Research and

Analytic Methods (CB7). (1) Provides

leadership to CDC and other

organizations on the allocation of

resources including the integration of

prevention research with policy needs,

and assists in making recommendations

for policy decisions based on

effectiveness and cost-effectiveness; (2)

promotes CDC’s capacity to conduct

epidemiologic, prevention effectiveness,

statistical, behavioral science, and

evaluative studies; (3) develops, adapts,

evaluates, and implements innovative

prevention effectiveness, epidemiologic,

statistical, evaluative, and behavioral

research methods; (4) provides

consultation, technical assistance and

training on analytic methods, data

management and collection, including

prevention effectiveness, epidemiologic

and statistical methods, evaluation, and

behavioral studies issues to CDC and to

other agencies and domestic and

international organizations; (5) develops

projects in defined urban populations in

which to evaluate the effectiveness of

prevention activities; (6) develops CDC

capacity and establishes a national

scientific network in epidemiologic,

behavioral, prevention effectiveness,

statistical, and outcome evaluation

science; (7) develops recommendations

and guidelines based on effectiveness,

cost-effectiveness, behavioral, outcome

evaluation, and statistical research to

enhance health promotion and disease

and injury prevention in various

settings and populations; (8) acquires,

develops, applies, and evaluates

statistical methods for use in public

health; (9) supports CDC activities

related to the Cochrane Collaboration;

(10) develops recommendations

(guidelines) based on effectiveness, costeffectiveness, behavioral, outcome

evaluation, and statistical research to

enhance health promotion and disease

and injury prevention in various

settings and populations; (11) designs

and conducts epidemiologic studies;

(12) in carrying out the above the

functions, collaborates, as appropriate,

with the other CDC CIOs.
51478 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices

Office of the Director (CB71). (1)

Manages, directs, and coordinates the

activities of the division; (2) provides

leadership and guidance on policy,

program planning, program

management, and operations; (3)

establishes division goals, objectives,

and priorities; (4) monitors progress in

implementation of projects and

achievement of objectives; (5) develops

and manages internship, fellowship,

and visiting scientist programs in

prevention effectiveness, evaluation,

behavioral science, and statistical

methodologies; (6) develops, conducts,

and provides support for training in

prevention effectiveness, evaluation,

behavioral science, epidemiologic and

statistical methodologies CDC-wide, as

well as at national, state, and local

levels; (7) provides management,

administrative and support services,

and coordinates with appropriate EPO

offices on program and administrative

matters; (8) provides liaison with other

CDC organizations, other governmental

agencies, international organizations,

and other outside groups; (9) plans,

allocates, and monitors resources; (10)

manages grants and CDC-wide

prevention effectiveness and statistical

analysis contracts; (11) provides support

for internal scientific advisory groups;

(12) provides scientific leadership and

guidance to the division to assure

highest scientific quality and ethical

standards.

Prevention Effectiveness Branch

(CB72). (1) Establishes capacity in the

public health community to conduct

and use prevention effectiveness

studies; (2) develops, adapts, evaluates,

and applies economic and decision

science methods for public health

applications; (3) provides economic

technical assistance, consultation,

direction, review, and information

resources to other organizations units

within EPO and throughout CDC; (4)

collects and analyzes data; (5) integrates

prevention research with policy needs;

(6) assists in making recommendations

for policy decisions on public health

policy based on prevention effectiveness

assessments of each prevention strategy;

(7) provides coordinative support for

CDC’s Prevention Effectiveness Working

Group.

Statistics and Epidemiology Branch

(CB73). (1) Provides and maintains

leadership in the acquisition,

development, application, and

evaluation of statistical and

epidemiologic methods for use in public

health; (2) provides statistical and

epidemiologic consultation, training,

and analytic assistance to EPO, other

components of CDC, and to outside

organizations; (3) conducts research in

methods development and evaluation;

(4) analyzes public health data; (5)

coordinates and supports CDC’s

Statistical Advisory Group; (6) provides

programming and data management

consultation and support for major

studies; (7) develops scientific methods

to address cross-cutting issues of

epidemiology, such as disabilities, race

and ethnicity, special settings, and

gender; (8) designs and conducts

epidemiologic studies to determine risk

factors and causes of selected diseases

and other conditions of public health

importance; (9) collaborates on

international epidemiologic and

statistical science projects by providing

technical assistance and consultation;

(10) supports the CDC-based Cochrane

Collaboration; (11) provides guidance

and supervision to EIS officers and

PMRs assigned to the division.

Community Preventive Services Guide

Section (CB732). (1) Coordinates and

develops community health practice

guidelines for the assessment of

effectiveness of prevention strategies; (2)

assists CRC programs on methods for

guidelines development processes; (3)

coordinates and manages CRC-wide

working group on practice guidelines

methodology; (4) convenes a task force

for development of community health

practice guidelines; (5) produces a

Guide to Community Health Practice

Guidelines based on available scientific

evidence; (6) identifies research needs

for developing science-based guidelines;

(7) updates guidelines on an ongoing

basis.

Evaluation and Behavioral Science

Methods Section (CB733). (1) Develops

a conceptual framework for conducting

behavioral and evaluation studies; (2)

organizes and establishes populations

for research in urban areas; (3) develops

within CDC outcome evaluation

capacity and systematize method for

evaluating health outcomes; (4)

develops key combinations of

evaluation and behavioral interventions

in urban populations; (5) provides

information for public policy for urban

areas by establishing credibility of the

scientific approach; (6) assists in making

recommendations for policy decisions;

(7) conducts public health surveillance

in urban health communities; (8)

provides technical assistance; (9)

provides coordinative support for CDC’s

Behavioral and Social Sciences Work

Group.

Division of International Health

(CB8). (1) Develops, promotes, and

conducts international training,

consultation, capacity building, and

other assistance in applied

epidemiology, public health

surveillance, and systematic use of

epidemiologic and other data for health

policy formulation, allocation of health

resources, and direction and evaluation

of public health program operations and

effectiveness; (2) provides policy

direction for all EPO activities

associated with international health; (3)

collaborates with the other CDC

organizations, international agencies,

foreign governments, and non-profit

organizations in support of EPO’s

international activities.

Office of the Director (CB81). (1)

Provides leadership and overall

direction for the division; (2) provides

leadership and guidance on policy,

program planning, program

management, and operations; (3) plans,

allocates, and monitors resources; (4)

provides leadership and management

oversight in assisting national ministries

of health, international agencies, and

non-profit organizations in the delivery

of epidemiologic services and the

development of international

epidemiologic networks; (5) provides

liaison with other CDC organizations,

other federal agencies, national

ministries of health, and international

organizations.

Data for Decision Making and Policy

Branch (CB82). (1) Plans, directs, and

coordinates data for decision making

activities, both foreign and domestic; (2)

assists with the development of capacity

to design and conduct economic

evaluation of health care interventions;

(3) collaborates with national ministries

of health to facilitate data use for policy

formulation, resource allocation, and

public health program management; (4)

provides leadership and expertise in

assisting national ministries of health

and domestic entities in utilizing

trained epidemiology generalists in

developing health policy and

implementing and evaluating health

programs; (5) collaborates with federal

agencies, national ministries of health,

international agencies, and non-profit

organizations to promote systematic use

of data to improve public health.

Program Development Branch (CB83).

(1) Plans, directs, and coordinates field

epidemiology training programs; (2)

provides leadership and management

oversight in assisting national ministries

of health in training epidemiology

generalists for future ministry positions

and for positions with international

organizations; (3) oversees provision of

consultation to national ministries of

health and international organizations

regarding epidemiologic practice,

surveillance systems development and

operation, and epidemiologic training;

(4) assigns professional epidemiologist

as long-term consultants to national

programs in epidemiologic training and
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Notices 51479

public health capacity development; (5)

provides on-site epidemiologic

consultation to national ministries of

health and international organizations

as required; (6) provides on-site

technical assistance, consultation, and

training to other countries and

international organizations in applied

communications, publications

management, health information

systems development and management,

and health economics.

Effective Date: September 19, 1997.

David Satcher,

Director.

[FR Doc. 97–25946 Filed 9–30–97; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0390 ]

Guidance for the Submission of

510(k)’s for Solid State X–Ray Imaging

Devices; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Guidance for the Submission of

510(k)’s for Solid State X-ray Imaging

Devices.’’ The draft guidance is neither

final nor is it in effect at this time. This

draft guidance applies to a new category

of medical devices, Solid State X-ray

Imagers (SSXI), and is currently

available for comment. This draft

guidance is intended to provide

guidance to the significant number of

premarket (510(k)) submissions

resulting from this new technology. The

draft guidance addresses the type of

data needed by the Center for Devices

and Radiological Health (CDRH) to

establish the substantial equivalence of

an SSXI to a previously cleared

conventional radiographic film/screen

system, fluoroscopic image intensified

imaging system, or SSXI.

DATES: Written comments by December

30, 1997.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for the

Submission of 510(k)’s for Solid State Xray Imaging Devices’’ to the Division of

Small Manufacturers Assistance (HFZ–

200), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Submit written comments on ‘‘Guidance

for the Submission of 510(k)’s for Solid

State X-ray Imaging Devices’’ to the

contact person listed below.

FOR FURTHER INFORMATION CONTACT:

Robert J. Doyle, Center for Devices and

Radiological Health (HFZ–476), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–594–

1212.

SUPPLEMENTARY INFORMATION: The final

version of this guidance will provide

instruction concerning the type of data

needed by CDRH to clear a new category

of medical devices, SSXI’s, for

marketing via section 510(k) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360(k)). This new

category of medical devices is intended

to replace conventional x-ray film/

screen systems and image intensifier

based fluoroscopic and image recording

systems. As solid state imaging

technology continues to progress, FDA

anticipates a significant number of

premarket (510(k)) submissions to be

based on this new technology. By

issuing the guidance, FDA hopes to

receive a larger percentage of complete

premarket submissions upon submittal.

This will avoid the need for additional

information requests which are time

consuming for both FDA and

manufacturers.

Under the Medical Device

Amendments to the act, a device may be

cleared for marketing via a 510(k)

premarket notification. To do so, the

device must be shown to be

substantially equivalent to a legally

marketed predicate device. This

guidance sets forth nonclinical and

clinical data necessary to establish the

substantial equivalence of the new

device to the identified predicate

device(s).

This draft guidance document

represents the agency’s current thinking

on the data necessary to establish the

substantial equivalence of SSXI to a

previously cleared device. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may, on or before

December 30, 1997, submit to the

contact person (address above) written

comments regarding this draft guidance.

Persons with access to the Internet may

obtain the draft guidance via the World

Wide Web (WWW) at ‘‘http://

www.fda.gov/cdrh’’.

Dated: July 31, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25992 Filed 9–30–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

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 62 FR 46751, dated

September 4, 1997) is amended to

reflect the organizational structure for

mine safety and health research

functions within the National Institute

for Occupational Safety and Health

(NIOSH), Centers for Disease Control

and Prevention.

Section C–B, Organization and

Functions, is hereby amended as

follows:

After the functional statement for the

Contracts and Purchases Branch

(CA582), Procurement and Grants Office

(CA58), Office of Program Support

(CA5), insert the following:

Contracts Management Branch

(Pittsburgh) (CA583). (1) Provides

leadership, direction, procurement

options and approaches in developing

specifications/statements of work and

contract awards; (2) Executes research

and development contracts for all of

NIOSH.

Revise the functional statement for

the Office of Administrative and

Management Services (CC11) to insert

the following as item (4) and renumber

the remaining items accordingly: (4)

provides management information,

advice, and guidance to CDC/OPS

regarding the conduct and the

evaluation of Staff Office procurement

activities with respect to their

effectiveness in meeting NIOSH’s

administrative and programmatic needs.

After the functional statement for the

Office of Administrative and

Management Services (CC11), insert the

following:

Administrative Services Branch

(Pittsburgh) (CC112). (1) Provides basic

facilities operations, maintenance, and