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) Start Printed Page 62457coordinates 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 Start Printed Page 62458mycobacteria, 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 Start Printed Page 62459other 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)Start Signature
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]
BILLING CODE 4160-18-M