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/ November
/ Tuesday, November 04, 2003
[Federal Register: November 4, 2003 (Volume 68, Number 213)]
[Notices]
[Page 62456-62459]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no03-56]
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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 67772-72, dated
October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as
amended most recently at 58 FR 53381-53383, dated September 10, 2003)
is amended to reflect the transfer of the Division of AIDS, STD, and TB
Laboratory Research from the National Center for Infectious Diseases to
the National Center for HIV, STD, and TB Prevention, excluding the
Hematologic Diseases Branch. The Hematologic Diseases Branch will be
transferred to the National Center on Birth Defects and Developmental
Disabilities and will be established as the Division of Hereditary
Blood Disorders.
Section C-B, Organization and Functions, is hereby amended as
follows:
Delete in its entirety the mission statement for the National
Center on Birth Defects and Developmental Disabilities (CF) and insert
the following:
The mission of the National Center on Birth Defects and
Developmental Disabilities (NCBDDD) is to improve the health of
children and adults by preventing birth defects and developmental
disabilities, and complications of heredity blood disorders; promoting
optimal child development, and the health and wellness among children
and adults living with disabilities. In carrying out this mission, this
organization: (1) Conducts public health research, epidemiological
investigations, and program demonstrations directed toward preventing
birth defects and developmental disabilities, and complications of
hereditary blood disorders, optimal fetal, infant, and child
development, and promoting the health and wellness of people with
disabilities, including the prevention of secondary conditions; (2)
plans, develops, establishes, and maintains systems of surveillance and
monitoring the population of these conditions; (3) operates regional
centers for the conduct of applied epidemiological research on these
conditions; (4) provides information and education to health care
providers, public health professionals, and the public on these
conditions; (5) provides technical assistance, consultation capacity
building through technology transfer, grants, cooperative agreements,
contracts, and other means to State, local, international, and
nonprofit organizations to prevent and control these conditions; (6)
provides training in the epidemiology of these conditions for health
professionals within and outside the United States; (7) translates
scientific findings into intervention, prevention, and health promotion
strategies; (8) conducts evaluation of programs to determine
effectiveness; (9) coordinates activities with other CDC organizations
and Federal and non-Federal health agencies, as appropriate.
Delete in its entirety the functional statement for the Office of
the Director (CF1) and insert the following:
(1) Directs, manages, and coordinates the activities of the
National Center on Birth Defects and Developmental Disabilities
(NCBDDD); (2) develops goals and objectives, provides leadership,
policy formulation, scientific oversight, and guidance in program
planning and development; (3) coordinates NCBDDD program activities
with other CDC components, Federal agencies, international
organizations, State and local health agencies, business and industry,
voluntary organizations, and community-based organizations; (4)
[[Page 62457]]
coordinates technical assistance to states, other nations and
international organizations; (5) coordinates with medical, scientific,
and other professional organizations interested in birth defects
prevention, pediatric genetics, developmental disabilities prevention,
and disabilities and health, and prevention of complications of
hereditary blood disorders; (6) advises the Director, CDC, on policy
matters concerning NCBDDD activities.
After the functional statement for the Division of Human
Development and Disability (CF3), insert the following:
Division of Hereditary Blood Disorders (CF4). (1) Designs and
manages a surveillance system to evaluate the incidence, morbidity, and
mortality of hemophilia, blood diseases and other hereditary disorders;
(2) plans, develops, and coordinates special surveys and populations
studies in selected geographic areas to monitor and assess the
complications of chronic blood diseases and chronic hereditary
disorders; (3) collects, analyzes, and prepares reports to document the
prevalence and incidence of blood diseases and chronic hereditary
disorders in the United States and provides this information to the
scientific community through reports, publications, and public access
data sets; (4) designs and implements studies using the surveillance
data to identify risk factors for the complication of blood diseases
and chronic heredity disorders, and evaluate the effectiveness of the
prevention activities; (5) conducts applied and operational research
related to disease definition, etiology, diagnosis, complications, and
prevention of blood diseases and chronic hereditary disorders; (6)
conducts epidemiologic studies in persons and their families with blood
diseases and chronic hereditary disorders; (7) plans, develops, and
coordinates special surveys and populations studies in selected
geographic areas to monitor and assess the complications of blood
diseases and chronic hereditary disorders; (8) provides epidemiologic
and medical consultation and technical assistance, including epidemic
aids, to State and local health departments, other governmental
agencies, and other public and private organizations in the
investigation of blood diseases and chronic hereditary disorders; (9)
designs and implements studies to evaluate the effectiveness of
implemented prevention strategies in the prevention centers; (10)
conducts applied research to develop, evaluate, improve, and
standardize the methods and procedures used for the classification,
surveillance, and prevention of blood diseases and chronic hereditary
disorders; (11) participates in research on the prevention of the
chronic complications of blood diseases and hereditary disorders; (12)
provides diagnostic support for epidemiologic studies and epidemic aids
on emerging blood diseases and chronic hereditary disorders; (13)
determines the mechanisms of pathogenesis and complications of blood
diseases and chronic hereditary disorders; (14) conducts research and
provides reference services on diagnostic techniques for blood diseases
and other hereditary disorders; (15) maintains the national reference
laboratory for blood diseases and chronic hereditary disorders; (16)
conducts research to improve laboratory methodologies and materials.
Office of the Director (CF41). (1) Provides national leadership in
the investigation and prevention of diseases of blood and chronic
hereditary disorders, including hemophilia, leading to disabilities;
(2) oversees investigations of diseases of blood and chronic hereditary
disorders and the role of etiologic agents in the development of these
disorders; (3) coordinates applied and operational research related to
disease definition, etiology, diagnosis, complication and prevention of
blood diseases and chronic hereditary disorders, consultation and
technical assistance to State and local health departments, other
governmental entities, and other public and private organizations in
the investigation of blood diseases and chronic hereditary disorders;
(4) provides training services to states, localities, and other
countries in investigation, diagnosis, prevention, and control of blood
diseases and chronic hereditary disorders; (5) assists in designing,
implementing, and evaluating prevention and counseling programs for
persons and their families with chronic blood diseases and selected
chronic hereditary disorders; (6) designs, implements and coordinates
the prevention and surveillance activities of specialized federally
funded prevention centers organized to prevent the complications of
blood diseases and chronic hereditary disorders; (7) designs,
implements and coordinates prevention activities of community based lay
groups so that the activities reinforce and compliment the activities
of the prevention centers; (8) participates in evaluation studies of
the effectiveness of prevention activities; (9) incorporates the
findings of the laboratory epidemiology and surveillance teams into
prevention activities; and (10) works closely with CDC organizations in
applying prevalence and incidence data to target and evaluate programs
to prevent the complications of blood diseases and chronic hereditary
disorders.
Delete the mission statement for the National Center for HIV, STD,
and TB Prevention (CK) and insert the following:
The mission of this organization is to provide leadership in
preventing and controlling human immunodeficiency virus infection,
other sexually transmitted diseases (STDs), and tuberculosis (TB) by
collaborating with community, state, national, and international
partners and applying well integrated, multi-disciplinary programs of
research, surveillance, technical assistance, and evaluation. In
carrying out this mission, the National Center for HIV, STD, and TB
Prevention (NCHSTP): (1) Coordinates the development of CDC short- and
long-range plans for preventing the spread of HIV infection in the
United States; (2) allocates and tracks CDC resources for HIV
prevention programs; (3) conducts national public information and
awareness activities; (4) coordinates HIV prevention activities with
other Federal agencies and with international organizations, including
the World Health Organization in conjunction with the Director, Office
of Global Health; (5) plans, directs, and coordinates national programs
of assistance involving preventive health services to State and local
health agencies; (6) assists State and local health agencies in
integrating and coordinating preventive services delivered by private
and public organizations in the community and in assuring delivery of
preventive services to all persons regardless of socioeconomic status;
(7) assists states and localities in specifying major health problems
in the community and in formulating technical theories on which
intervention strategies can be based; (8) serves as the primary focus
for assisting states and localities through grants and other
mechanisms, in establishing and maintaining prevention and control
programs directed toward health problems related to acquired
immunodeficiency syndrome, sexually transmitted diseases, and
tuberculosis; (9) maintains operational knowledge of the nature, scope,
and occurrence of preventable health problems; (10) conducts
operational research to improve the assistance programs; (11) conducts
applied and operational research relating to the distribution,
diagnosis, prevention, and control of HIV and other STDs, TB, non-TB
[[Page 62458]]
mycobacteria, and non-HIV Retroviruses, including vaccine development;
(12) provides reference diagnostic services for HIV and other STDs, TB,
non-TB mycobacteria, and non-HIV Retroviruses; (13) provides technical
assistance to states and localities and to other nations in the
investigation and diagnosis of STDs, TB, HIV, and Retroviruses; (14)
assesses program operations and public health practices and provides
technical assistance to states in the operation of preventive health
service programs; (15) maintains liaison with other U.S. governmental
agencies, State and local health agencies, national organizations, and
educational institutions; (16) provides technical assistance to other
nations; (17) in carrying out the above functions, collaborates, as
appropriate, with other Centers, Institute, and Offices (CIOs) of the
CDC.
Delete the functional statement for the Office of the Director
(CK1) and insert the following:
(1) Provides leadership and guidance on the development of goals
and objectives, policies, program planning and development, program
management and operations of the activities of the NCHSTP; (2) manages,
directs, coordinates, and evaluates the Center's activities; (3)
facilitates closer linkages between HIV, STD, and TB surveillance
activities and prevention programs at all levels, (4) facilitates
collaboration, integration, and multi-disciplinary approaches to
enhance the effectiveness of HIV, STD, and TB prevention programs; (5)
facilitates integration of science and prevention programs throughout
the NCHSTP; (6) enhances the coordination and integration of HIV, STD,
and TB prevention services for individuals and populations at increased
risk for more than one of these infections; (7) coordinates the
integration of CDC funding of state and local health departments for
HIV, STD, and TB prevention; (8) facilitates the assignment of field
staff in accordance with CDC and NCHSTP priorities and objectives; (9)
reassesses the role of NCHSTP field staff assignees to state and local
health jurisdictions and restructures career development plans
accordingly; (10) provides and coordinates administrative and program
support services; (11) provides technical information services to
facilitate dissemination of relevant public health information; (12)
facilitates collaboration with national health activities with CDC
components, other agencies and organizations, and foreign governments
on international health activities; (13) provides oversight for the
programmatic coordination of HIV, STD, and TB activities between NCHSTP
and other CIOs and, as the lead CIO for these programs, develops
recommendations to the CDC Director in concert with other CIOs, for
distribution of HIV, STD, and TB funds CDC-wide; (14) advises the
Director, CDC, on other policy matters concerning NCHSTP activities.
After the functional statement for the Global AIDS Program (CK6),
insert the following:
Division of AIDS, STD, and TB Laboratory Research (CK7). (1)
Develops and evaluates laboratory methods and procedures for the
diagnosis and characterization of infections caused by human
immunodeficiency virus (HIV) and other retroviruses, other sexually
transmitted diseases (STDs), and mycobacteria including Mycobacterium
tuberculosis; (2) provides laboratory support for the surveillance,
epidemiologic, clinical, and prevention activities of the Center; (3)
conducts applied research on the pathogneesis of, and the immune
mechanisms that occur in, microbial infections; (4) provides reference
laboratory services and assists in standardizing and providing
laboratory reagents; (5) serves as a World Health Organization
Collaborating Center for Reference and Research in Syphilis Serology
and for HIV isolation, detection, and characterization; and (6)
coordinates research on opportunistic infections occurring in HIV-
infected persons.
Office of the Director (CK71). (1) Plans, directs, and coordinates
the activities of the Division; (2) develops goals and objectives and
provides leadership, policy formulation, and guidance in program
planning and development; (3) provides program management and
administrative support services for AIDS/STD/TB laboratory research
activities, both domestic and international.
HIV and Retrovirology Branch (CK72). (1) Conducts studies of human
immunodeficiency viruses (HIVs) and other human and zoonotic
retroviruses, including the diseases they cause, their modes of
transmission, and the means for their control through virus detection,
isolation, and characterization by virologic, molecular, and cellular
biologic methods; (2) collaborates with NCHSTP investigators to conduct
HIV epidemiologic and surveillance studies worldwide particularly as
they pertain to prevention and intervention strategies; (3) identifies
and characterizes new HIV isolates and develops new screening tests for
these isolates to determine their prevalence in various populations;
(4) determines genotypic and phenotypic variations of HIVs that may
affect pathogenesis, drug resistance, persistence, virulence, and
transmissibility; (5) conducts and supports field epidemiologic
investigations of the prevalence, distribution, trends, and risk
factors associated with non-AIDS retroviral infections and associated
diseases; (6) serves as a World Health Organization (WHO) Reference
Center and as a member of the UNAIDS Virus Network to provide
international consultation and technical assistance on laboratory
procedures for HIV isolation, detection, and characterization; (7)
develops and evaluates procedures for the isolation and
characterization of HIV and for the detection of retroviral DNA or RNA
from clinical samples; (8) provides training, reference testing, and
reference reagents for virologic and molecular characterization of
divergent HIVs for public health laboratories in the United States and
WHO; (9) serves as a reference laboratory for the isolation of zoonotic
retroviruses from clinical samples; (10) develops collaborations with
other CDC and non-CDC scientists to promote scientific progress and
accomplishments; and (11) collaborates with industry to promote
commercialization of useful technology, methodologies, or reagents of
public health importance.
HIV Immunology and Diagnostics Branch (CK73). (1) Conducts basic
and applied studies of microbial-host interactions that occur in
infections, particularly infection with human immunodeficiency virus
(HIV); (2) conducts basic and applied investigations of the immune cell
interactions that occur in HIV infection as well as in related
immunologic/infectious diseases; conducts investigations of genetic
traits of the host that influence the susceptibility, disease course,
and immune response to infectious disease, particularly HIV disease;
(3) conducts studies related to the development, evaluation,
improvement, and standardization of laboratory technologies used for
the diagnosis, surveillance, and monitoring of HIV infection both
independently and in collaboration with the biotechnology industry; (4)
performs HIV antigen and antibody testing plus related standardized
assays in support of the diagnostic /surveillance/epidemiologic
requirements of CDC-based and CDC-affiliated studies of the HIV
epidemic; (5) serves as a reference laboratory for State and local
health departments; and (6) provides diagnostic services to other
Federal agencies, the World Health Organization, CDC-affiliated
academic centers, CDC-affiliated studies with
[[Page 62459]]
other countries, and community organizations, as appropriate.
Sexually Transmitted Infections Branch (CK74). (1) Performs
research on the pathogenesis, genetics, and immunology of syphilis and
other treponematoses, gonococcal and chlamydial infections, chancroid,
genital herpes, donovanosis, bacterial vaginosis and trichomoniasis;
(2) conducts and participates in clinical, field, and laboratory
research to develop, evaluate, and improve laboratory methods used in
the diagnosis and epidemiology of these sexually transmitted infections
(STIs); (3) provides consultation and reference/diagnostic services for
these STIs; (4) conducts laboratory-based surveillance for and research
on the genetics of antimicrobial resistance in Neisseria gonorrhoeae;
(5) serves as the WHO International Collaborating Center for Reference
and Research in Syphilis Serology; and (6) provides consultation and
laboratory support for international activities.
Tuberculosis/Mycobacteriology Branch (CK75). (1) Provides
laboratory support for epidemic investigations, surveillance
activities, and special studies of tuberculosis and other mycobacteria-
caused diseases; (2) administers contracts to provide Mycobacterium
tuberculosis genotyping, maintains a national database of genotypes,
and conducts operational research to implement genotyping; (3) develops
and evaluates new methods to subtype mycobacteria for epidemiologic
studies; (4) serves as primary CDC focus for diagnostic
mycobacteriology laboratory services and for laboratory aspects of
nontuberculosis Mycobacterium species and of Hansen disease (leprosy);
(5) administers grants and cooperative agreements with states and
others to upgrade laboratory activities and provide special services;
(6) provides reference diagnostic services, consultation, technical
assistance, and training to State, Federal, and municipal public health
laboratories; (7) provides laboratory support, reference services,
assessment, consultation, and training for CDC's international
tuberculosis activities; (8) develops, evaluates, or improves
conventional and molecular methods for the detection, classification,
identification, characterization, and susceptibility testing of
mycobacteria and mycobacteria-caused diseases; (9) conducts studies to
define the role of bacterial virulence factors, host factors, and
pathogenic and immunologic mechanisms in disease processes and
protective immunity and develops, evaluates, and improves immunologic
methods for the diagnosis and prevention of mycobacteria-caused
diseases; (10) develops tissue culture and animal models of
mycobacteria-caused diseases and conducts studies on chemotherapy,
immunotherapy, pathogenesis, pathology, and vaccines for mycobacteria-
caused diseases; (11) conducts studies on the isolation, taxonomy, and
ecology of mycobacteria and develops tests to identify new species;
(12) conducts and supports studies to characterize newly emerging
pathogenic species of Mycobacterium and associated diseases.
Delete in their entirety the following titles and functional
statements:
Division of AIDS, STD, and TB Laboratory Research (CRN)
Office of the Director (CRN1)
Hematologic Diseases Branch (CRN3)
Laboratory Section (CRN32)
Surveillance and Epidemiology Section (CRN33)
Tuberculosis/Mycobacteriology Branch (CRN8)
Diagnostic Mycobacteriology Section (CRN82)
Immunology and Molecular Pathogenesis Section (CRN83)
HIV and Retrovirology Branch (CRNA)
Viral Evolution and Transmission Section (CRNA2)
Retroviral Genetics Section (CRNA3)
Molecular Epidemiology and Zoonoses Section (CRNA4)
Virology Section (CRNA5)
HIV Immunology and Diagnostics Branch (CRNB)
Gonorrhea Research Branch (CRNC)
Syphilis and Chlamydia Branch (CRND)
Treponema Section (CRND2)
Chlamydia Section (CRND3)
Dated: October 20, 2003.
William H. Gimson,
Chief Operating Officer, Centers for Disease Control and Prevention
(CDC).
[FR Doc. 03-27627 Filed 11-3-03; 8:45 am]
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