81 FR 70423 - Statement of Organization, Functions, and Delegations of Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 197 (October 12, 2016)

[Federal Register Volume 81, Number 197 (Wednesday, October 12, 2016)]
[Notices]
[Pages 70423-70425]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24640]


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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 81 FR 66284-66285,

[[Page 70424]]

dated September 27, 2016) is amended to reflect the reorganization of 
the Division of Scientific Resources, National Center for Emerging and 
Zoonotic Infectious Diseases, Office of Infectious Diseases, Centers 
for Disease Control and Prevention.
    Section C-B, Organization and Functions, is hereby amended as 
follows:
    Delete and replace the title and the mission and function 
statements for the Division of Scientific Resources (CVLH) and insert 
the following:
    Division of Scientific Resources (CVLH). The Division of Scientific 
Resources (DSR) provides products, services, and specialized expertise 
to CDC staff and activities in support of research and service 
activities: In carrying out its mission, DSR: (1) Provides animals, 
laboratory supplies, animal and human blood products, glassware, 
mammalian tissue cultures, microbiological media, special reagents, and 
other laboratory materials in support of research and service 
activities to laboratories and investigators at CDC; (2) develops and 
implements applied research programs to expand and enhance the use of 
animal models necessary to support research and diagnostic programs and 
to improve breeding and husbandry procedures; (3) conducts applied 
research in cell biology and in the expansion of tissue culture 
technology as a research and diagnostic tool for infectious disease 
activities; (4) provides services for laboratory investigators in 
protein and DNA synthesis and sequencing, genomic sequencing, 
microarrays, proteomics, and molecular modeling; (5) maintains a bank 
of serum and other biological specimens of epidemiological and special 
significance to CDC's research and diagnostic activities; (6) obtains 
and distributes experimental and orphaned vaccines, drugs, antisera, 
antitoxins, and immune globulins; (7) manages and distributes the 
inventory, maintains the computerized system database, and provides 
general technical service support for the dispensing, lyophilizing, 
capping, and labeling of CDC reference reagents; (8) receives, triages, 
processes, and distributes specimens to CDC laboratories for reference 
diagnostic testing, research studies, and epidemics and reports 
diagnostic test results to submitting organizations; (9) manages all 
CDC exports and ensures compliance with regulations and serves as CDC 
liaison with the Department of Commerce for export related issues; (10) 
produces and distributes specialized reagents and kits for the 
detection of select agents to members of the Laboratory Response 
Network; (11) provides services and expertise in development of quality 
systems to support compliance with the Food and Drug Administration 
regulations on production, distribution, and use of laboratory 
diagnostic reagents; (12) provides liaison activities, resources, and 
expertise for inquiries related to animals and zoonotic diseases; and 
(13) provides a centralized activity for tracking requests for and 
distributing select agents to investigators outside of CDC in 
compliance with federal regulations.
    Office of the Director (CVLH1). (1) Manages, directs, and 
coordinates the activities of DSR; (2) provides leadership and guidance 
on policy, budget, program planning and development, program 
management, and operations; (3) provides DSR-wide administrative and 
program services and coordinates or ensures coordination with the 
appropriate CIOs, OID, and CDC staff offices on administrative and 
program matters; (4) provides liaison with other governmental agencies, 
international organizations, and other outside groups; (5) coordinates, 
in collaboration with the appropriate CIOs, OID, and CDC components, 
laboratory activities relating to support of outbreak investigations or 
laboratory-based research including but not limited to specimen 
management, biological reagents, and laboratory supplies; (6) maintains 
a formulary of investigational and licensed drugs and biologicals that 
are distributed to approved physicians for the prevention, control, 
and/or treatment of rare, tropical, or exceptional diseases; (7) 
advises the Director, NCEZID, on policy matters concerning DSR 
activities; and (8) coordinates technical services for laboratory 
activities of CDC programs including procurement of glassware and 
laboratory supplies.
    Comparative Medicine Branch (CVLHB). (1) Acquires and distributes 
laboratory animals for research; (2) provides appropriate housing, 
husbandry, and psychological enrichment for all research animals; (3) 
provides veterinary services, including clinical and surgical support, 
for the laboratory animals; (4) develops standard operating procedures 
for animal care and use in accordance with the policies established by 
the American Association for Accreditation of Laboratory Animal Care, 
the Animal Welfare Act, The Guide for the Care & Use of Laboratory 
Animals, and the CDC International Animal Care & Use Committee; (5) 
conducts applied research to improve the care and use of animals in 
research and collaborates on research projects that use laboratory 
animals; (6) provides consultation and laboratory animal technology 
training to investigators, technical staff and animal care personnel; 
(7) provides oversight, support and investigator training for the 
graphical animal information technology protocol development and animal 
tracking database; (8) coordinates technical services for laboratory 
activities of CDC programs including processing and distribution of 
glassware and related items, laboratory waste decontamination and 
disposal, laundry services, and materiel management; and (9) provides 
autoclave label production services.
    Biotechnology Core Facility Branch (CVLHD). (1) provides state-of-
the-art next-generation genomic sequencing and metagenomics analysis of 
infectious and biothreat agents; (2) provides optical mapping to 
produce high resolution whole-genome maps for strain typing, molecular 
epidemiology, comparative genomics, and quality control for whole 
genome sequence assembly; (3) provides computational analysis of 
genomics sequencing data, bioinformatics, and biological computing; (4) 
provides qualitative and quantitative proteomic analyses 
(identification of expressed proteins by mass spectrometry); analysis 
of functionally-relevant post-translational modifications of proteins; 
(5) provides mass spectrometry-based positive identification of 
bacteria and fungi (BioTyperTM, Bruker Daltonics); (6) provides 
synthetic oligonucleotide chemistry in support of development of rapid 
diagnostic tests and characterization of pathogens and their hosts; (7) 
provides synthetic peptide chemistry in support of studies of immune 
response and antigen-antibody interactions; (8) provides biotechnology 
seminars and methods evaluation; (9) provides laboratory equipment 
design and repair services to all CDC; and (10) collaborates on 
research related to STD transmitted infections as chronic infectious 
diseases.
    Reagent and Diagnostic Services Branch (CVLHG). (1) maintains 
laboratory water treatment systems to ensure quality of CDC reagent 
grade laboratory water; (2) produces, develops, evaluates and 
distributes custom microbiological and cell culture media, buffers and 
chemical reagent, mammalian and insect cell cultures, hybridomas, 
monoclonal and polycolonal antibodies, and in vitro diagnostic products 
for diagnostic research purposes, proficiency testing, pandemic 
preparedness, outbreak response and surveillance activities; (3) 
collaborates with subject matter experts

[[Page 70425]]

in regulatory compliant development, production, packaging, storing and 
distribution of BSL2/BSL3 reagents, select agents, novel immuno-
chemical reagents and reference diagnostic reagents; (4) provides 
dispensing, lyophilizing, label production, and device assembly 
services; (5) improves the process of bench-top development and in-
house pilot scale production providing immediate availability for 
distribution, preventing backorders and streamlining commercialization; 
(6) maintains CDC's Biological Reference Reagent Inventory, mammalian 
cell line repository and a serviceable inventory at the DSR Continuity 
of Operations storage facility; (7) provides centralized specimen 
management services for diagnostic, reference, and outbreak 
investigations; maintains a bank of biological specimens of 
epidemiological significance to CDC's research and diagnostic 
activities; manages and tracks systems of specimen collections; (8) 
receives, triages, processes, stores and distributes specimens to CDC 
laboratories for reference diagnostic testing, research studies, and 
reports diagnostic and surveillance test results to submitting 
organizations; (9) serves as central facility for acquisition and 
distribution of fresh human blood, blood products, and serum in bulk; 
(10) packages and ships infectious substances and other materials, 
ensuring compliance with regulations for shipping clinical specimens, 
infectious substances, and other materials; (11) manages all CDC 
exports and ensures compliance with regulations and serves as CDC 
liaison with Department of Commerce for export related issues; and (12) 
provides consultation in all of the above technical services.

Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2016-24640 Filed 10-11-16; 8:45 am]
BILLING CODE 4160-18-P