[Federal Register Volume 68, Number 109 (Friday, June 6, 2003)]
[Notices]
[Pages 33956-33957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14223]


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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 67772-76, 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

[[Page 33957]]

human 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.

    Dated: May 15, 2003.
William H. Gimson,
Chief Operating Officer, Centers for Disease Control and Prevention 
(CDC).
[FR Doc. 03-14223 Filed 6-5-03; 8:45 am]
BILLING CODE 4160-18-M