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Statement of Organization, Functions, and Delegations of Authority

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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 20, 1980, as amended most recently at 68 FR 7118-7123, dated February 12, 2003) is amended to reorganize the National Center for Health Statistics.

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

Delete in its entirety the functional statement for the Division of Environmental Health Laboratory Sciences and insert the following:

Division of Laboratory Sciences (HCN8). (1) Develops and maintains a national laboratory response capability for applying state-of-the-art biomonitoring technology to improve the detection, prevention, and public health management of chemical terrorism emergencies and emergencies resulting from human exposure to toxic chemicals; (2) develops and applies biomonitoring methods for environmental chemicals that identify chemicals to which people are exposed and measures individual exposure levels; (3) applies biomonitoring measurements to determine the exposure of the general U.S. population to selected environmental chemicals, to assess the exposure of special population groups that are known or suspected to be at high-risk of excessive exposure, and study to the relationship between level of exposure and adverse health effects; (4) provides technical assistance, technology transfer, reference laboratory measurements, laboratory standardization programs, and external quality assurance to State and local public health laboratories and health officials; Federal agencies; international organizations; academic, international, and private laboratories; and professional organizations to improve laboratory science and laboratory capacity in the fields of environmental health and selected chronic diseases; (5) develops and validates advanced laboratory technology to assess nutritional and genetic risk factors for environmental disease and selected chronic diseases; and (6) collaborates with other CDC organizations; Federal, State, and local agencies; and private and professional organizations to investigate new or emerging health problems known to potentially related to exposure to environmental chemicals.

Clinical Chemistry Branch (HCN85). (1) Provides statistical consultation in areas of research, study design, analysis, reporting, and quality control development for laboratory investigations and environmental health studies to NCEH staff, other Federal agencies, State and local public health departments, and other national and international organizations; (2) provides system analysis, computer programming and interfacing, technical support, and application of computerization and other advanced technology to the resolution of laboratory problems and data analysis, management, reporting, and presentation; (3) maintains reference methods for epidemiologic studies and clinical trials which provide the basis for public health strategies to reduce morbidity and mortality due to cardiovascular disease. In this capacity, serves as the WHO Collaborating Center for Reference and Research in Blood Lipids; (4) develops, evaluates, and standardizes analytical methods for the measurement of biochemical markers for assessing disease status and risk for selected chronic diseases; (5) designs and implements collaborative programs with appropriate agencies or professional groups to effect technology transfer, improvement of proficiency and quality, and the standardization of analytical performance among health laboratories involved in clinical and epidemiologic investigations; (6) provides technical assistance and guidance to governmental agencies, professional societies, and the general clinical laboratory community on pre-analytical issues, measurement problems, study design, and reference and quality control material preparation, storage, and handling; and (7) develops, prepares, and distributes purified and biological reference materials used for standardization programs, quality control assessment, and calibration of analytical methods in research.

Emergency Response and Air Toxicants Branch (HCN88). (1) Develops and maintains analytical methods to measure, in human specimens, toxic substances that are known or potential agents for use in chemical terrorism; (2) applies these measurements in response to chemical terrorism emergencies and, as part of a coordinated Federal response, deploys a rapid response laboratory team to assist in obtaining Start Printed Page 33957human specimens for analysis; (3) transfers technology, provides training, and provides technical assistance for measurement of chemical agents in human specimens to a network of laboratories that provide additional capacity for responding to chemical terrorism; (4) provides review and expert consultation to Federal, state, local and international governments and health organizations on assessing and interpreting biomonitoring measurements of chemical agents likely to be used in terrorism; (5) for toxic substances of public health concern but unlikely to be involved in chemical terrorism, transfers biomonitoring technology, provides biomonitoring training, and provides technical assistance in biomonitoring to state laboratories, including methods for analyzing both inorganic and organic toxic substances in human specimens; (6) develops and maintains analytical methods to measure organic toxic substances that contaminate air (air toxicants) in human specimens and applies these analytical methods to assess human exposures to these chemicals for many purposes, including surveillance of levels in the population, epidemiological studies, and emergency response investigations; and (7) develops and maintains analytical methods to assess human exposure to tobacco smoke and its chemical constituents and applies these methods to epidemiologic studies of tobacco smoke exposure and related disease.

Inorganic Toxicants and Nutrition Branch (HCN84). (1) Develops and maintains analytical methods to measure trace-essential and toxic elements in human specimens; (2) applies these analytical methods to assess human exposures to these chemicals for many purposes, including surveillance of levels in the population, epidemiological studies, and emergency response investigations; (3) provides training, guidance, and assistance to State and local governments, and domestic and international laboratories in the development, maintenance and technology transfer of analytical capability for measurement of trace-essential and toxic elements in specimens from humans, animals, and the environment; (4) develops and maintains analytical capability and expertise in the measurement and interpretation of physiologic levels of micronutrients such as the vitamins, essential elements, and other dietary substances or their metabolites (as biomarkers); (5) provides technical assistance to national, state, international and local investigations, surveys, and clinical studies of the nutritional status, prevalence, risk factors, and treatment of chronic diseases; and (6) develops, maintains, and distributes, as appropriate, standards, reference materials, protocols, and standardization programs to assist state, international and other laboratories in the transfer of laboratory technology and in establishing and maintaining quality control and calibration of analytical methods for essential and toxic elements, nutrients, and markers of physiologic damage.

Molecular Biology Branch (HCN87). (1) Collaborates in the development and implementation of large, population-based, genetic repositories comprising specimens from nationally representative samples of healthy people, patients, unaffected family members, or unrelated control subjects; (2) develops and evaluates laboratory methods in genetics and develops, evaluates, and standardizes auto-antibody measurements; (3) uses population-based and disease-based repositories to study genetic risk factors for disease and gene-environment interactions; (4) provides advice and technical assistance to state and local health departments, other Federal agencies, national and international organizations, and academic centers on laboratory measurements in genetics; and (5) develops, maintains, and distributes appropriate standards, reference materials, and protocols for diabetes auto-antibody measurement.

Newborn Screening Branch (HCN82). (1) Provides technical consultation and assistance concerning quality assurance and procedural issues to State Public Health laboratories, international laboratories, and manufacturers of diagnostic products involved in performing newborn screening tests; (2) develops and maintains analytical methods to measure substances in dried-blood spots (DBSs), and produces certified DBS quality control and reference materials for newborn screening tests; (3) maintains a DBS proficiency testing program for newborn screening programs worldwide for inborn errors of metabolism, hemoglobinopathies, and other newborn disorders; (4) provides technical and administrative support to public health laboratory projects for early detection of autoimmune, immuno-proliferative, and immuno-deficiency diseases; and (5) evaluates and refines emerging laboratory methods for micro- and nano-detection to public health applications and population-based screening for these immune disorders.

Organic Analytical Toxicology Branch (HCN86). (1) Develops and maintains analytical methods to measure selected synthetic and naturally occurring organic chemicals, their metabolites, and reaction products (adducts) in human specimens; (2) applies these analytical methods to assess human exposures to these chemicals for many purposes, including surveillance of levels in the population, epidemiological studies, and emergency response investigations; (3) aids in transferring these methods within Division laboratories and to state, local and other public health laboratories; (4) develops and prepares various matrix-based quality control materials for use in such analyses; and (5) provides review, expert consultation, and original scientific publications/information to Federal, state, local, and international governments and health organizations on topics related to human exposure assessment, organic analytical methodology, high technology analytical instrumentation, preparation and analysis of biological specimens, quality control procedures, laboratory safety, and medical interpretation of laboratory findings.

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Dated: May 15, 2003.

William H. Gimson,

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

End Signature End Preamble

[FR Doc. 03-14223 Filed 6-5-03; 8:45 am]

BILLING CODE 4160-18-M