05-21672. 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 30, 1980, as amended most recently at 69 FR 77756, dated December 28, 2004) is amended to reorganize the National Center for HIV, STD, & TB Prevention.

Section C-B, Organization and Functions, is hereby amended as follows:

Delete in its entirety the following titles and functional statements: Division of AIDS, STD & TB Laboratory Research (CK7), Office of the Director (CK71), HIV, Immunology and Diagnostics Branch (CK72), HIV Immunology and Diagnostics Branch (CK73), Sexually Transmitted Infectious Diseases Branch (CK74), Tuberculosis/Mycobacteriology Branch (CK75).

Following the Training and Health Communication Branch (CK37), Division of STD Prevention (CK3), insert the following:

Laboratory Reference and Research Branch, (CK38). (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.

Following the International Research and Programs Branch (CK47), Division of Tuberculosis Elimination (CK4), insert the following:

Mycobacteriology Branch (HCK48). (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.

Following the HIV Incidence and Case Surveillance Branch (CK56), Division of HIV, AIDS Prevention—Surveillance and Epidemiology (CK5), insert the following:

HIV and Retrovirology Laboratory Branch (HCK57). (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 geotypic 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, and reagents of public health importance.

HIV Immunology and Diagnostic Laboratory Branch (HCK58). (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 diseases; (3) conducts studies related to the development, evaluation, improvement, and standardization of laboratory technologies uses 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 other countries, and community organizations, as appropriate.

Dated: April 1, 2005.

William H. Gimson,

Chief Operating Officer, Centers for Disease Control and Prevention (CDC).