[Federal Register Volume 60, Number 166 (Monday, August 28, 1995)]
[Notices]
[Pages 44507-44511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21302]



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[[Page 44508]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 67772-76, dated 
October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as 
amended most recently at 60 FR 34550-51, dated July 3, 1995) is amended 
to reflect the consolidation of related laboratory research functions 
within the national Center for Infectious Diseases (NCID) to enhance 
coordination of HIV, STD, and TB activities throughout the Centers for 
Disease Control and Prevention (CDC).
    Section HC-B, Organization and Functions, is hereby amended as 
follows:
    Delete the title and functional statement for the Division of 
Sexually Transmitted Diseases Laboratory Research (HCRN) and the Office 
of the Director (HCRN1), and insert the following:
    Division of AIDS, STD, and TB Laboratory Research (HCRN). (1) 
Develops and evaluates laboratory methods and procedures for the 
diagnosis and characterization of infections caused by HIV and other 
human retroviruses, other sexually transmitted diseases, and 
mycobacteria, including M. tuberculosis; (2) provides laboratory 
support for the surveillance, epidemiologic, and clinical activities of 
the National Center for Prevention Services and other Centers/
Institute/Offices; (3) conducts applied research on immune mechanisms 
that occur in microbial infection, particularly infection with human 
immunodeficiency virus; (4) conducts applied research on the 
pathogenesis of microbial infections, particularly infection with M. 
tuberculosis; (5) conducts laboratory studies of hemophilia and other 
coagulating disorders; (6) provides reference laboratory services and 
assists in standardizing and providing laboratory reagents; (7) serves 
as a World Health Organization Collaborating Center; (8) conducts 
epidemiologic studies of HIV-infected and uninfected persons with 
hemophilia and their families; (9) assists in designing, implementing, 
and evaluating prevention and counseling programs for HIV-infected 
persons with hemophilia and their families; (10) coordinates research 
on opportunistic infections in HIV-infected persons.
    Office of the Director (HCRN1). (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.
    Gonorrhea, Chlamydia, an Chancroid Branch (HCRN2). (1) Performs 
research and development on gonorrhea, chancroid, donovanosis, 
bacterial vaginosis, and chlamydial and mycoplasmal infections; (2) 
conducts or participates in clinical, field, and laboratory research to 
develop, evaluate, and improve laboratory methods and materials used in 
the diagnosis of STDs; (3) provides consultation and reference/
diagnostic services for STDs other than syphilis.
    Chlamydia Section (HCRN22). (1) Performs research and development 
on the pathogenesis, genetics, immunology, and epidemiology of 
chlamydial and mycoplasmal infections and donovanosis; (2) conducts or 
participates in clinical, field, and laboratory research to develop, 
evaluate, and improve laboratory methods and materials used in the 
diagnosis of these agents; (3) provides consultation and reference/
diagnostic services for these agents.
    Gonorrhea and Chancroid Section (HCRN24). (1) Performs research and 
development on the pathogenesis, genetics, immunology, and epidemiology 
of gonorrhea, chancroid, and bacterial vaginosis; (2) conducts or 
participates in clinical, field, and laboratory research to develop, 
evaluate, and improve laboratory methods and materials used in the 
diagnosis of these agents; (3) provides consultation and reference/
diagnostic services for these agents.
    Hematologic Diseases Branch (HCRN3). (1) Provides national 
leadership in the investigation and prevention of diseases of blood 
including hemophilia; (2) conducts investigations of hematologic 
disorders and the role of etiologic agents in the development of these 
disorders; (3) conducts applied and operational research related to 
disease definition, etiology, diagnosis, complications, and prevention 
of hemophilia and acquired hematologic diseases; (4) conducts research 
on the prevention of the chronic complications of hematologic 
disorders; (5) provides technical assistance and reference and 
diagnostic services to State and local health departments, other 
Federal agencies, and other organizations; (6) conducts research to 
improve laboratory methodologies and materials; (7) provides training 
services to states, localities, and other nations in investigation, 
diagnosis, prevention, and control of hematologic diseases; (8) 
conducts epidemiologic studies in persons with hemophilia and chronic 
hematologic disorders and their families; (9) assists in designing, 
implementing, and evaluating prevention and counseling programs for 
persons with hemophilia and their families.
    Laboratory Section (HCRN32). (1) Conducts applied research to 
develop, evaluate, improve, and standardize the methods and procedures 
for the microbiologic classification, surveillance, and prevention of 
hematologic diseases; (2) participates in studies directed at 
determining methods of preventing hematologic disorders and their 
complications; (3) provides diagnostic support for epidemiologic 
studies and epidemic aids on emerging hematologic diseases; (4) 
determines the mechanisms of pathogenesis of chronic hematologic 
disorders and their complications; (5) conducts research and provides 
reference services on hematologic diagnostic techniques; (6) maintains 
the national reference laboratory for blood coagulation and other 
hematologic disorders.
    Surveillance and Epidemiology Section (HCRN33). (1) Designs and 
manages a surveillance system to evaluate the incidence, morbidity, and 
mortality of hemophilia and other hematologic disorders; (2) plans, 
develops, and coordinates special surveys and populations studies in 
selected geographic areas to monitor and assess the complications of 
hemophilia; (3) determines, plans, conducts, and coordinates 
surveillance training for State and local health department staff; (4) 
collects, analyzes, and prepares reports to document the prevalence and 
incidence of hemophilia and other blood diseases in the United States 
and provides this information to the scientific community through 
reports, publications, and public access data sets; (5) 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 hematologic disorders; (6) works closely with CDC 
organizations in applying prevalence and incidence data to target and 
evaluate hematologic disease prevention program; (7) designs and 
conducts epidemiologic studies to determine risk factor and co-factors 
for chronic hematologic disorders and their 

[[Page 44509]]
complications; (9) provides statistical support in the design and 
analysis of data from surveillance and epidemiologic studies.
    Treponemal Pathogenesis and Immunobiology Branch (HCRN4). (1) 
Performs research and development on syphilis and other treponematoses, 
such as yaws and endemic syphilis; (2) conducts or participates in 
clinical, field, and laboratory trials to develop, evaluate, and 
improve laboratory methods and materials used in the diagnosis of 
syphilis; (3) provides consultation and reference/diagnostic services 
for syphilis; (4) conducts research in the cellular and humoral aspects 
of the immune response to the treponemes and immunochemical studies of 
the organism to define antigenic determinants; (5) serves as the WHO 
International Collaborating Center for Reference and Research in 
Syphilis Serology.
    Treponemal Immunobiology Section (HCRN42). (1) Conducts research 
leading to an understanding of the in vitro growth requirements of 
treponemes; (2) studies the human cellular immune response to infection 
with HIV and Treponema pallidum; (3) provides reference diagnostic 
services for syphilis and other treponematoses; (4) prepares reference 
reagents for nontreponemal tests; (5) conducts clinical evaluations; 
(6) serves as a WHO Collaborating Center for the Treponematoses.
    Treponemal Pathogenesis Section (HCRN44). (1) Conducts research 
leading to an understanding of the inter-relationship of the host and 
the microorganism through studies of the antigenic composition of the 
treponeme, the role of treponemal enzymes in the production of the 
infection, in vivo growth requirements, and humoral immune response of 
the host; (2) prepares reference reagents for treponemal tests; (3) 
produces monoclonal antibodies; (4) determines differences between 
strain isolates from patients with HIV infection and syphilis and 
isolates from patients with syphilis alone.
    HIV Laboratory Investigations Branch (HCRN5). (1) Provides 
laboratory support for epidemiologic and surveillance studies in 
collaboration with the National Center for Prevention Services; (2) 
conducts investigations of viral pathogenesis and evaluation of control 
measures through the use of animal models and in vitro techniques 
employing clinical specimens from HIV-infected individuals; (3) trains, 
performs reference testing, and develops certain reference reagents for 
HIVs for public health laboratories in the United States and the World 
Health Organization; (4) serves as a reference laboratory for the 
isolation, detection, and serologic testing for HIV in clinical samples 
and assists in providing laboratory training to public health and other 
laboratory personnel; (5) assists in standardizing and providing 
reference reagents for HIV; (6) serves as a World Health Organization 
Reference Center 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; (8) develops and evaluates new 
and improved methods for the serodiagnosis of HIV infection and 
detection of viral genetic information in infected cells; (9) conducts 
investigations of HIV and HIV-infected cells to determine how the virus 
impairs the immune system and to identify indicators for disease 
progression; (10) conducts investigations to identify and characterize 
new HIV isolates and to develop new diagnostic tests for these isolates 
to determine the prevalence in various populations; (11) collaborates 
with other Federal, academic, and private laboratories.
    Cell Biology Section (HCRN52). (1) Develops and evaluates 
laboratory methods and procedures for the isolation and 
characterization of HIV; (2) conducts research into the molecular 
virology of HIV virulence, latency, replication, and pathogenesis as 
pertains to their role in the progression of AIDS and transmittance of 
the virus; (3) provides reference isolation services for HIV; (4) 
identifies mixed infections in association with HIV and conducts 
research at a molecular level into their impact on viral pathogenesis 
and AIDS; (5) assists in providing training to public health 
laboratorians and consultation to CDC as a whole on the isolation and 
culture of HIV; (6) provides international consultation and technical 
assistance on laboratory methods for HIV isolation and 
characterization.
    Developmental Technology Section (HCRN53). (1) Develops and 
evaluates laboratory methods for the detection of HIV infection and 
understanding of HIV pathogenesis; (2) cooperates with industry in 
conducting clinical trials and other evaluations of new AIDS diagnostic 
tests; (3) conducts quality assurance program for assay materials used 
in HIV surveillance; (4) assists in standardization and provision of 
reference reagents; (5) assists in providing training and technical 
assistance to public health laboratorians on the serologic testing for 
HIV antigens and antibodies; (6) provides international training and 
technical assistance on laboratory methods for HIV serology and other 
tests for HIV infection.
    Molecular Biology Section (HCRN54). (1) Develops, evaluates, 
improves, and standardizes DNA probe technology including gene 
amplification for the diagnosis, characterization, and understanding of 
the pathogenesis of HIV; (2) investigates the molecular basis of the 
interactions between HIV and host cells with an emphasis on the 
requirement of human factors necessary for the expression and 
replication of HIV; (3) participates in a national screening program 
for the evaluation and characterization of HIV nucleotide sequences for 
determining evolution of HIV; (4) provides intramural and extramural 
technical expertise and assistance in professional training of 
molecular approaches to the identification of HIV and other infectious 
agents; (5) conducts molecular investigations on the biochemical and 
biological properties of HIV proteins.
    Serology Section (HCRN55). (1) Provides epidemic aid and reference 
serologic testing services for HIV; (2) assists in the evaluation of 
improved methods for HIV serodiagnosis; (3) assists in providing 
training to public health laboratorians on serologic testing of HIV; 
(4) assists in the standardization and provision of reference reagents; 
(5) provides national and international consultation and technical 
assistance on laboratory methods for HIV serology.
    Immunology Branch (HCRN6). (1) Conducts applied research on immune 
mechanisms that occur in microbial infection, particularly infection 
with human immunodeficiency virus; (2) conducts studies on natural 
history, mechanisms of infection, immunopathogenesis, and the biology 
of host-microbe interaction to distinguish immune responses that are 
effective versus deleterious and identifies targets for immune 
intervention; (3) develops, evaluates, and improves assay procedures 
for immune mechanisms and diagnosis of diseases; (4) performs 
immunologic diagnostic testing for laboratories and organizations 
within NCID and CDC, and outside the Agency; (5) performs or 
collaborates in the performance of clinical, epidemiologic, and field 
studies of immunologic disease states.
    Retrovirus Diseases Branch (NCRN7). (1) Conducts research to 
further understanding of the human and zoonotic retroviruses, the 
diseases they cause, the modes of transmission, and the means for their 
control through 

[[Page 44510]]
virus detection, isolation, and characterization, by virologic, 
molecular, and immunologic methodologies; (2) determines virus 
genotypic variation, phenotypic (serologic) variation, pathogenesis, 
tropisms, persistence, virulence, and transmissibility; (3) conducts 
field epidemiologic investigations of the prevalence, distribution, 
trends, and risk factors associated with non-AIDS retroviral diseases; 
(4) conducts research to further the understanding of how human 
retroviruses modulate the function of infected cells, and how 
intracellular signals regulate retroviral gene expression; (5) develops 
collaborations with other CDC scientists and scientists from external 
labs to maximize resources and promote scientific progress and 
accomplishments; (6) develop collaborations with industry to promote 
commercialization of useful technology, methodologies or reagents 
resulting from section research.
    Immunology Section (HCRN72). (1) Develops new methods to improve 
the detection of immunologic markers of retrovirus infection and to 
enhance prevention of retrovirus-associated morbidity and mortality 
through immunologic research; (2) analyzes structural and functional 
characteristics of retroviral antigens in order to develop more 
sensitive and specific serologic assays for retroviral detection; (3) 
investigates host cellular and humoral immune responses to retroviral 
infection to determine factors that regulate retroviral disease 
expression; (4) analyzes soluble factors that modulate retroviral 
expression; (5) provides reference diagnostic testing for samples with 
unusual seroreactivity or from patients with unusual clinical 
presentation; (6) determines the natural history of retroviruses by 
characterizing samples collected world-wide; (7) develops 
collaborations with other CDC scientists and scientists from external 
labs to maximize resources and promote scientific progress and 
accomplishments; (8) develops collaborations with industry to promote 
commercialization of useful technology, methodologies or reagents 
resulting from section research.
    Molecular Genetics Section (HCRN73). (1) Provides molecular 
genetics expertise for public health investigations concerning human 
and zoonotic retroviruses; (2) develops and applies new molecular 
technologies to monitor and investigate retroviral epidemiology, 
natural history, and pathogenesis; (3) identifies and characterizes new 
and emerging retroviruses by novel molecular methods; (4) investigates 
viral load and viral mutagenesis to determine correlations with disease 
progression in vivo; (5) studies molecular level virus-host 
interactions that promote viral replication and transmission; (6) 
develops collaborations with other CDC scientists and scientists from 
external labs to maximize resources and promote scientific progress and 
accomplishments; (7) develops collaborations with industry to promote 
commercialization of useful technology, methodologies or reagents 
resulting from section research.
    Virology Section (HCRN74). (1) Enhances prevention of retrovirus-
associated morbidity and mortality through laboratory research focused 
on the biology of human and zoonotic retroviruses and their target 
cells in the host; (2) investigates the factors that govern the 
progression from HIV-infection to AIDS and interventions that may 
prevent AIDS; (3) determines the factors that control the regulation of 
retroviral expression through studies of retroviral latency, activation 
and replication; (4) develops improved methods for culture and 
identification of known and novel retroviruses; (5) discovers new 
markers for retrovirus infection and disease progression that will 
further the understanding of retroviral epidemiology; (6) develops new 
cellular models for retrovirus studies; (7) develops collaborations 
with other CDC scientists and scientists from external labs to maximize 
resources and promote scientific progress and accomplishments; (8) 
develops collaborations with industry to promote commercialization of 
useful technology, methodologies or reagents resulting from section 
research.
    Tuberculosis/Mycobacteriology Branch (HCRN8). (1) Provides 
laboratory support for epidemic investigations and special studies of 
tuberculosis and other mycobacterial diseases; (2) conducts research 
into immunology of mycobacterial infections, pathogenic mechanisms, and 
molecular basis of diseases; (3) provides reference diagnostic services 
to State public health laboratories; (4) administers grants and 
cooperative agreements with States and others to upgrade laboratory 
activities and provide special services; (5) develops, evaluates, and/
or improves methods for classifying and identifying mycobacteria and 
mycobacterial diseases; (6) develops tissue culture and animal models 
of mycobacterial diseases that can be used in studies of chemotherapy, 
immunotherapy and vaccine evaluations; (8) studies problems of 
isolation, taxonomy, and ecology of mycobacteria; (9) investigates 
mycobacteria for identification of virulence factors.
    Diagnostic Mycobacteriology Section (HCRN82). (1) Provides 
laboratory support to the Division of Tuberculosis Elimination and 
others for epidemic investigations of tuberculosis; (2) manages the 
Regional Network for RFLP typing and maintains the national database 
describing patterns of isolates from throughout the United States; (3) 
develops new methods that subtype mycobacteria for use as epidemiologic 
markers; (4) provides reference services for identification and drug 
susceptibility testing of referred isolates; (5) develops new 
diagnostic methods for rapid identification and susceptibility testing 
of Mycobacterium species; (6) evaluates newly developed diagnostic 
tests and procedures; (7) provides consultation and training to State, 
federal and municipal public health laboratories; (8) serves as the 
primary CDC focus for studies of nontuberculosis Mycobacterium species; 
(9) supports and encourages studies on role of nontuberculous 
mycobacteria in human and animal disease; (10) studies characteristics 
of Mycobacterium species that infect humans.
    Immunology and Molecular Pathogenesis Section (HCRN83). (1) 
Conducts studies to define the molecular genetics of mycobacteria and 
develop molecular tools for the detection and prevention of 
mycobacterial infections; (2) defines mechanisms of drug resistance in 
mycobacteria and develops methods for rapid detection of resistance; 
(3) conducts studies to define the role of host-pathogen factors and 
immunologic mechanisms in disease processes and protective immunity; 
(4) develops, evaluates, and improves immunologic/serologic methods for 
the diagnosis and prevention of mycobacterial diseases; (5) conducts 
studies to identify and characterize virulence factors, pathogenic 
mechanisms, and the molecular basis of disease caused by mycobacteria; 
(6) develops and evaluates agents for the treatment and prevention of 
mycobacterial diseases; (7) develops animal models for study of 
detection, treatment, and characteristics of mycobacterial diseases; 
(8) serves as the primary CDC focus for studies of Hansen disease 
(leprosy).
    Delete the functional statement for Emerging Bacterial and Mycotic 
Diseases Branch (HCRP8), Division of Bacterial and Mycotic Diseases 
(HCRP) and insert the following: (1) In collaboration with other CDC 
Centers/Institute/Offices and other NCID Divisions, conducts laboratory 
studies 

[[Page 44511]]
and provides epidemic aid, surveillance, and consultation on the 
control of emerging, reemerging, and opportunistic bacterial, fungal, 
actinomycotic, and nontuberculosis mycobacterial diseases; (2) provides 
reference and diagnostic activities for agents causing these diseases 
and for the identification of unknown bacterial, fungal, and 
actinomycotic isolates associated with human disease; (3) performs 
studies to determine host-parasite factors related to human diseases 
caused by emerging, reemerging, and opportunistic bacterial, fungal, 
actinomycotic, and nontuberculosis mycobacterial agents; (4) 
coordinates and collaborates in national and international studies and 
surveillance for bacterial, fungal, mycobacterial, and actinomycotic 
diseases; (5) develops and evaluates methods for the diagnosis of 
emerging, reemerging, and opportunistic bacterial, fungal, and 
actinomycotic diseases; (6) develops, implements, and evaluates 
prevention strategies for these diseases; (7) collaborates with other 
CDC Centers/Institute/Offices, NCID Divisions, State and Federal 
agencies in addressing reemerging bacterial and mycotic diseases.
    Delete the functional statement for the Epidemiology Section 
(HCRP82), Emerging Bacterial and Mycotic Diseases Branch (HCRP8), and 
insert the following: (1) Conducts epidemic investigations, 
surveillance, and special studies of emerging, reemerging, and 
opportunistic bacterial, fungal, actinomycotic, and mycobacterial 
diseases; (2) provides clinical and epidemiologic consultation on these 
diseases; (3) coordinates activities related to opportunistic 
infections in compromised hosts for the Division.
    Delete the title and functional statement for the Tuberculosis and 
Other Mycobacterioses Laboratory Section (HCRP85), Emerging Bacterial 
and Mycotic Diseases Branch (HCRP8), Division of Bacterial and Mycotic 
Diseases (HCRP).
    Delete the title and functional statement for the Retrovirus 
Diseases Branch (HCRUA), Division of Viral and Rickettsial Diseases 
(HCRU).

    Effective Date: August 15, 1995.
David Satcher,
Director, Centers for Disease Control and Prevention.
[FR Doc. 95-21302 Filed 8-25-95; 8:45 am]
BILLING CODE 4160-18-M