[Federal Register Volume 59, Number 79 (Monday, April 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9421]


[[Page Unknown]]

[Federal Register: April 25, 1994]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Centers for Disease Control and Prevention

 

Statement of Organization, Functions, and Delegations of 
Authority

    Part H, Chapter HC (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 67772-67776, 
dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, 
as amended most recently at 59 FR 1749, dated January 12, 1994, and 
corrected at 59 FR 4720-4721, dated February 1, 1994) is amended to 
establish the substructure within the National Immunization Program, 
Centers for Disease Control and Prevention (CDC).
    Section HC-B, Organization and Functions, is hereby amended as 
follows:
    After the functional statement for the National Immunization 
Program (HCJ), Office of the Director (HCJ1), insert the following:
    Polio Eradication Activity (HCJ12). (1) Plans, coordinates, 
directs, and participates in National Immunization Program (NIP) 
efforts to eradicate polio in collaboration with the World Health 
Organization (WHO) and its Regional Offices, and other Centers/
Institute/Offices (CIO); (2) provides short- and long-term consultation 
and technical assistance to foreign countries involved in the global 
eradication of polio and participates in international advisory group 
meetings regarding polio eradication; (3) conducts large-scale clinical 
trials of oral and injectable poliovirus vaccines in collaboration with 
WHO, other national governments and international research groups; (4) 
designs and participates in international research projects to increase 
the effectiveness of polio eradication strategies; (5) develops 
strategies to improve the technical skills and problem-solving 
abilities of program managers and health care workers in other 
countries; (6) refines strategies developed for the eradication of 
polio in the Western Hemisphere for implementation in other parts of 
the world; (7) assist other countries in projects to improve 
surveillance for polio and other vaccine-preventable diseases, 
including development of computerized systems for disease monitoring; 
(8) prepares articles based on findings for publication in 
international professional journals and presentation at international 
conferences; (9) collaborates with advocacy groups, and other 
countries, to ensure the availability of sufficient funds to purchase 
an adequate supply of polio vaccine for use in polio eradication 
efforts.
    Data Management Division (HCJ2). (1) Plans, designs, directs, 
develops, and implements information systems development activities, 
including all activities associated with immunization information 
systems; (2) works with external collaborators, such as State 
immunization programs, software vendors, health care providers, etc., 
to develop appropriate software; (3) works in close collaboration and 
provides technical support to the other Divisions of the Program; (4) 
plans, directs, and coordinates the assessment and statistical analysis 
and statistical research of the Program; (5) provides technical 
assistance and consultation to State and local health departments and 
other organizations in the design and operation of immunization level 
assessment systems for preschool and school-aged children and evaluates 
the effectiveness of these assessment activities; (6) provides 
technical support and consultation to State and local health 
departments and other organizations regarding statistical and 
analytical methods; (7) works in close collaboration with CDC CIOs and 
State and local health departments on the development of new software 
for information tracking, data collection systems, and program 
management, evaluation, and operations.
    Systems Development Branch (HCJ22). (1) Develops, implements, and 
maintains software required for the administrative activities of the 
Program and Divisions; (2) provides Divisions with the necessary 
software to efficiently track and manage grantee activities; (3) 
coordinates with NIP, Information Resources Management Office and other 
CIOs for the development of administrative software that will integrate 
with existing CDC Information System (CDC/IS) standards; (4) assists 
grantees in developing, writing, and implementing specialized software 
applications for program management, program operations, and program 
evaluation; (5) revises and refines software applications developed by 
the Program to interface with grantees' specific data reporting 
requirements; (6) coordinates information flow among the Program, 
Divisions, grantees, and private contractors regarding the interactive 
data systems development for immunization information systems; (7) 
coordinates all administrative interactions between all interested 
parties involved in development; (8) interacts with and promotes 
immunization information systems with national organizations 
representing both public and private health providers; (9) assists 
grantees in developing immunization information systems which will 
exchange information among grantees and health providers and allow 
transition to changes and/or restructuring of the health care systems; 
(10) designs, develops, implements all training activities associated 
with immunization information system databases; (11) develops and 
maintains liaison with external groups regarding systems development; 
(12) evaluates the effectiveness of relevant Program and grantee 
systems development operations; (13) provides the Program, Divisions, 
State, and local health departments with technical advice relative to 
procurement of software and hardware needs for task accomplishment.
    Assessment Branch (HCJ23). (1) Establishes, implements, monitors, 
and maintains the standards and procedures for immunization-related 
data collection for data analysis; (2) acts as liaison with program 
statisticians, epidemiologists, and/or public health advisors on all 
aspects of data collection and quality assurance for each Program 
study, survey, and surveillance system; (3) determines the most 
appropriate implementation procedure for data management activities; 
(4) performs coding and editing, and arranges for data input either in-
house or through an outside vendor; (5) establishes and evaluates data 
quality control measures to assure that all Program studies, surveys 
and surveillance systems adhere to the established standards and 
procedures from data collection to the point of data analysis; (6) 
provides documented datasets upon completion of studies and surveys; 
(7) directs the assessment of immunization levels for the national 
population and specific population subsequents; (8) collaborates with 
the National Center for Health Statistics, and other CIOs as necessary, 
in the conduct of household probability surveys, random digit dialing 
surveys, and other types of surveys to measure immunization coverage; 
(9) develops and maintains liaison with external groups regarding 
assessment; (10) collects, tabulates, and analyzes immunization 
assessment data, including sample survey data, complete census counts 
at school entrance, monthly and/or quarterly vaccine administration 
reports, and the biologic reports from manufacturers.
    Statistical Analysis Branch (HCJ24). (1) Provides technical support 
and consultation to the Program and to State and local health 
departments regarding statistical and analytical methods, data 
collection for epidemic investigations of childhood and adult vaccine-
preventable diseases, review and/or preparation of protocols for 
special study situations such as vaccine trials, vaccine efficacy 
studies, etc., and vaccine safety surveillance; (2) provides 
statistical consultation and performs primary statistical analysis, 
including experimental design, for the research activities of the 
Program; (3) designs sample surveys for epidemiologies investigations 
for childhood and adult vaccine-preventable diseases; (4) performs 
statistical computations and applies appropriate statistical procedures 
in analysis of routine, non-research-related data; (5) maintains 
liaison with and provides statistical consultation to national, State, 
local, and international agencies relative to immunization statistical 
activities; (6) evaluates the effectiveness of relevant Program and 
grantee statistical analyses operations; (7) participates in and 
provides analytical expertise relative to on-site investigations.
    Epidemiology and Surveillance Division (HCJ3). (1) Directs all 
Program activities regarding epidemiology, national surveillance, 
research and technical consultation for pertussis, diphtheria, tetanus, 
polio, measles, mumps, rubella, varicella, and the vaccines and toxoids 
to prevent these diseases, has the lead responsibility for vaccine 
safety, and takes an active role in the development of policy related 
to the epidemiology and surveillance of vaccine-preventable diseases; 
(2) collaborates with other CDC CIOs in epidemiologic and national 
surveillance activities for Haemophilus influenzae type b disease; (3) 
provides medical and epidemiologic expertise and collaborates with 
other CDC CIOs in developing strategies to enhance immunization 
coverage of adults, including influenza, pneumococcal, hepatitis B, 
measles, mumps, and rubella vaccines and combined tetanus and 
diphtheria toxoids; (4) directs national surveillance of diphtheria, 
pertussis, tetanus, polio, measles, mumps, rubella, congenital rubella, 
varicella, complications arising from these diseases, and adverse 
events following vaccination; (5) monitors vaccine safety, and conducts 
scientific research to evaluate the safety of all currently available 
and new vaccines; (6) develops strategies for designated national and 
international vaccine-preventable disease control programs and/or 
disease elimination activities; (7) provides epidemic aid in 
collaboration with other CDC CIOs, during outbreaks of designated 
vaccine-preventable diseases and consultation to State and local health 
departments and to foreign countries on these diseases and their 
prevention; (8) provides consultation and assistance to public health 
professionals on designated vaccine-preventable diseases, vaccines, and 
biological products; (9) directs epidemiologic research to evaluate the 
efficacy, safety, and cost effectiveness of designated vaccines, and to 
study aspects of vaccine-preventable diseases relevant to immunization 
practice; (10) collaborates wit the Advisory Committee on Immunization 
Practices in the development of vaccine policy in the public health 
sector.
    Vaccine Safety and Development Activity (HCJ3-2). (1) Coordinates a 
national surveillance program monitoring vaccine safety in 
collaboration with the Food and Drug Administration (FDA); (2) 
collects, analyzes, and evaluates data to determine the safety of 
designated vaccines; (3) prepares and distributes surveillance 
information pertaining to the monitoring of adverse events following 
immunization; (4) conducts ad-hoc studies and investigations pertaining 
to adverse events following immunization; (5) coordinates studies using 
large linked data bases to evaluate the potential causal relationship 
of vaccination with specific health outcomes; (6) collaborates with 
other CIOs, the FDA, the National Institute of Allergy and Infectious 
Diseases, the Health Resources and Services Administration, and the 
National Vaccine Program in development and execution of a coordinated 
national plan to improve vaccine safety; (7) assists the National 
Vaccine Compensation Program in analyzing data from cases seeking 
compensation; (8) provides consultation to State and local health 
departments pertaining to the monitoring and reporting of adverse 
events following immunization; (9) prepares articles based on findings 
of studies for publication in professional journals and presentation at 
professional conferences; (10) collaborates with partners, including 
other CDC CIOs, FDA, etc., in the Children's Vaccine Initiative (CVI) 
to develop combined vaccines that can be integrated into national and 
international immunization programs; (11) participates in trials of 
combined vaccines developed under the CVI; (12) participates in 
international as well as domestic vaccine research activities.
    Adult Vaccine-Preventable Diseases Branch (HCJ33). (1) Provides 
medical and epidemiologic expertise and collaborates with other CDC 
CIOs in developing strategies to enhance immunization coverage of 
adults, including influenza, pneumococcal, hepatitis B, measles, mumps, 
and rubella vaccines and combined tetanus and diphtheria toxoids; (2) 
plans, coordinates, participates in, and collaborates on research to 
determine the most effective means of encouraging the use of vaccines 
targeted for adults; (3) collaborates with private sector partners in 
the development and implementation of adult immunization strategies; 
(4) conducts demonstration projects to assess the feasibility of 
various vaccine delivery systems and determine the most cost-effective 
means of reaching the adult population with the designated vaccines; 
(5) evaluates the effectiveness of relevant vaccine-preventable disease 
activities and cost-effectiveness of relevant vaccines; (6) prepares 
information and statements for appropriate advisory committees 
pertaining to adult immunization; (7) prepares and reviews articles for 
publication in professional journals and presentation at professional 
conferences; (8) provides scientific support to other CDC CIOs in the 
development of effective communications techniques/mechanisms; (9) 
participates in national and international epidemiologic research 
activities.
    Child Vaccine-Preventable Diseases Branch (HCJ34). (1) Provides 
consultation on the use of vaccines and toxoids recommended for 
children (DTP/DTaP, polio, measles, mumps, rubella, Haemophilus 
influenzae type b, hepatitis B, and varicella, when licensed) and the 
prevention of these diseases; (2) provides consultation and support to 
State and local health departments in the investigation of epidemics 
and other problems related to diphtheria, pertussis, tetanus, polio, 
measles, mumps, rubella, and varicella; (3) conducts national 
surveillance of diphtheria, pertussis, tetanus, polio, measles, mumps, 
rubella, and varicella, investigates outbreaks, and recommends 
appropriate control measures; (4) prepares and distributes surveillance 
information pertaining to the diseases noted in (3); (5) in 
collaboration with other CDC CIOs, conducts national surveillance of 
Haemophilus influenzae type b disease and provides consultation and 
support to State and local health departments in the investigation of 
Haemophilus influenzae types b epidemics; (6) analyzes and prepares 
information and statements for appropriate advisory committees on 
diphtheria, pertussis, tetanus, polio, measles, mumps, rubella, and 
varicella, as well as other vaccines that may be designated in the 
future; (7) evaluates the effectiveness of relevant vaccine-preventable 
disease activities; (8) conducts epidemiologic studies to determine 
efficacy, safety, and cost effectiveness of new and currently used 
vaccines; (9) conducts research projects to enhance the use of these 
vaccines and scientifically evaluate immunization delivery systems; 
(10) prepares and reviews articles based on study findings for 
publication in professional journals and makes presentations at 
professional conferences; (11) provides scientific support to other CDC 
CIOs in the development of effective communications techniques/
mechanisms; (12) collaborates with the WHO, the Pan American Health 
Organization, as well as other national and international agencies on 
investigating disease outbreaks, conducting epidemiologic research, and 
developing strategies for the prevention and elimination of vaccine-
preventable diseases.
    Immunization Services Division (HCJ4). (1) Provides technical and 
administrative assistance to State and local health departments and 
other organizations in the implementation of immunization programs; (2) 
supervises public health advisor field staff; (3) implements the 
Vaccines for Children Program and ensures appropriate management of the 
Federal vaccine contracts; (4) conducts operational research 
demonstration projects designed to test different hypotheses and 
various interventions to improve vaccine coverage among specific target 
groups; (5) collaborates with relevant Federal, State, and local health 
agencies, such as the National Vaccine Program, Administration for 
Children and Families (specifically Aid to Families with Dependent 
Children), the Department of Agriculture (specifically the Women, 
Infants, and Children Supplemental Foods Program), and the Health 
Resources and Services Administration, Bureau of Primary Health Care 
(BPHC), on all immunization issues related to the populations they 
serve; (6) provides operational and programmatic assistance to State 
and local health departments and other organizations seeking to 
implement proven interventions and initiatives; (7) works with non-
governmental organizations, such as community-based organizations and 
national minority organizations, to determine the most effective 
methods of serving racial/ethnic minority and other populations at 
increased risk of vaccine-preventable diseases; (8) collaborates with 
other Divisions, CIOs, PHS and DHHS as necessary to accomplish goals of 
the Program; (9) makes recommendations through the NIP Office of the 
Director to the Procurement and Grants Office (PGO), on all grantee 
funding requests; (10) plans and directs all informational, 
educational, promotional, mobilization, and training activities of the 
Program.
    Communications, Training, and Community Resources Branch (HCJ42). 
(1) Responsible for implementing national outreach, mobilization, and 
public information activities to increase the demand for vaccines and 
to improve health care provider immunization practices; (2) 
collaborates with nongovernmental organizations (NGO), such as 
community-based organizations (CBO) and national minority organizations 
(NMO) to determine the most effective methods of serving racial/ethnic 
minority populations at increased risk of vaccine-preventable diseases; 
(3) works with local community organizations, national medical, 
voluntary, educational, private industry organizations, and local 
health departments to establish collaborative mechanisms which foster 
the linkages between immunization services and the community; (4) 
develops an internal staff of culturally competent persons to work with 
staffs of NMOs, NGOs, and CBOs, while promoting cultural competency 
throughout the Program; (5) provides technical support to other CDC 
CIOs in the development of effective communications techniques/
mechanisms; (6) designs, develops, coordinates, implements, and updates 
training and education materials for health providers to improve their 
immunization practices; (7) develops and coordinates distribution of 
immunization information materials about specific diseases targeted to 
specific ethnic and minority populations as well as the general public; 
(8) collects, analyzes, summarizes, and distributes information on 
educational and programmatic activities through a newsletter and other 
means of communication; (9) plans and coordinates the National 
Immunization Conferences and other conferences and meetings as 
required; (10) evaluates effectiveness of educational activities, and 
uses findings to improve future activities; (11) serves as liaison with 
media for coverage of special events; (12) establishes and maintains a 
clearinghouse and hotline for informational, educational, and 
promotional materials proposed, developed, or completed by other 
agencies and private organizations; (13) maintains, revises, and 
arranges for translation, publication, and distribution of the 
Important Information Statements and the Vaccine Information Materials.
    Program Operations Branch (HCJ43). (1) Provides technical and 
administrative assistance to immunization grantees in the Public Health 
Service Regions I through X; (2) provides program consultant, 
epidemiologic, statistical, and project officer support for all 
immunization grantees; (3) makes recommendations through the NIP Office 
of the Director to the PGO, on all grantee funding requests; (4) 
ensures that immunization grant funds awarded to grantees are expended 
in an appropriate manner; (5) provides technical support to all grant-
related activities, including implementation of Immunization Action 
Plans, development of active surveillance systems of vaccine-
preventable diseases, intensive epidemiologic investigation of reported 
cases, and incorporation of epidemiologic expertise in programmatic 
issues; (6) makes recommendations to grantees about needed changes in 
program content, policy or implementation; (7) oversees the performance 
and development of Federal direct assistance assignees to State/local 
immunization programs and determines changes in staffing and 
assignments; (8) develops and maintains liaison and support with 
appropriate external organizations.
    Field Operations Section (Regions I-V) (HCJ432). (1) Provides 
technical, epidemiologic, scientific, statistical, and administrative 
support to immunization grantees in the Public Health Service Regions I 
through V; (2) provides program consultant and project officer support 
for all grantees in these regions; (3) makes recommendations through 
the NIP Office of the Director to the PGO, on all grantee funding 
requests; (4) ensures that immunization grant funds awarded to grantees 
in these five regions are expended in an appropriate manner; (5) 
supports grantees in implementation of all grant-related activities 
(e.g., implementation of Immunization Action Plans, the Standards for 
Pediatric Immunization Practices, new/revised vaccine recommendations, 
and the hepatitis B prevention program); (6) makes recommendations to 
grantees about needed changes in program content, policy or 
implementation; (7) assists the Program Operations Branch Chief and the 
Division Director in overseeing the performance of Federal direct 
assistance assignees to State/local immunization programs and informs 
the Branch Chief and Division Director of their performance, strengths/
weaknesses, training needs, and of needed changes in staffing and 
assignments.
    Field Operations Section (Regions VI-X) (HCJ433). (1) Provides 
technical, epidemiologic, scientific, statistical, and administrative 
support to immunization grantees in the Public Health Service Regions 
VI through X; (2) provides program consultant and project officer 
support for all grantees in these regions; (3) makes recommendations 
through the NIP Office of the Director to the Grants Management Branch, 
PGO, on all grantee funding requests; (4) ensures that immunization 
grant funds awarded to grantees in these five regions are expended in 
an appropriate manner; (5) supports grantees in implementation of all 
grant-related activities (e.g., implementation of Immunization Action 
Plans, the Standards for Pediatric Immunization Practices, new/revised 
vaccine recommendations, and the hepatitis B prevention program); (6) 
makes recommendations to grantees about needed changes in program 
content, policy or implementation; (7) assists the Program Operations 
Branch Chief and the Division Director in overseeing the performance of 
Federal direct assistance assignees to State/local immunization 
programs and informs the Branch Chief and Division Director of their 
performance, strengths/weaknesses, training needs, and of needed 
changes in staffing and assignments.
    Program Support Branch (HCJ44). (1) Implements the Vaccines for 
Children Program, which provides federally purchased vaccine to 50-70 
percent of all children in the United States; (2) collaborates with 
PGO, CDC to negotiate vaccine contracts; (3) interacts with States to 
ensure an adequate supply of vaccine is provided for eligible children; 
(4) provides programmatic assistance and project officer oversight to 
operational research demonstration projects and the implementation of 
new and/or special initiatives; (5) tests specific hypotheses and 
relevant interventions designed to improve vaccine coverage among 
specific target groups; (6) collaborates with relevant Federal, State, 
and local health agencies on the operational research issues related to 
the populations they serve and the scientific evaluation of 
immunization delivery systems; (7) provides operational and 
programmatic assistance to State and local health departments and other 
groups attempting to implement roven interventions and initiatives; (8) 
uses research to determine the best means of modifying behavior to 
ensure children are appropriately immunized; (9) provides technical 
support to grantees regarding procedures for collecting data needed to 
better direct program resources toward improving immunization levels; 
(10) evaluates the effectiveness of these data collection methods; (11) 
provides necessary training to grantees in utilizing computer 
technology as a management tool.

    Effective Date: April 19, 1994.
David Satcher,
Director.
[FR Doc. 94-9421 Filed 4-22-94; 8:45 am]
BILLING CODE 4160-18-M