•

  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"Table%201.%20The%20Prion%20Diseases"  Table 1. The Prion Diseases

•

  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"Table%202.%20Standard%20precautions*%20for%20autopsies%20of%20patients%
20with%20suspected%20prion%20disease"  Table 2. Standard precautions*
for autopsies of patients with suspected prion disease

•

  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"Table%203.%20Autopsy%20suite%20decontamination%20procedures"  Table 3.
Autopsy suite decontamination procedures

•

  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"Table%204.%20Brain%20cutting%20procedures"  Table 4. Brain cutting
procedures

•

  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"Table%205.%20Tissue%20preparation"  Table 5. Tissue preparation

•

  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"References"  References

 	BMBL Section VII

Agent Summary Statements

Section VII-D: Prions

  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/biosfty.htm"  Biosafety
Documents

  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4toc.htm"  BMBL
Table of Contents

The Centers for Disease Control and Prevention and the National
Institutes of Health wish to express our appreciation to Jiri Safar,
M.D.; Darlene Groth, A.B.; Stephen J. DeArmond, M.D., Ph.D.; and Stanley
B. Prusiner, M.D., of the University of California San Francisco, San
Francisco, CA, for their contributions to this emerging field and the
preparation of this section.

Prions are proteinaceous infectious particles that lack nucleic acids.
HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_1_"  (1)  Prions are composed largely, if not entirely, of an
abnormal isoform of a normal cellular protein. In mammals, prions are
composed of an abnormal, pathogenic isoform of the prion protein (PrP),
designated PrPSc. The "Sc" superscript was initially derived from the
term scrapie because scrapie is the prototypic prion disease. Since all
of the known prion diseases (Table 6) of mammals involve aberrant
metabolism of PrP similar to that observed in scrapie, use of the "Sc"
superscript is suggested for all abnormal, pathogenic PrP isoforms.
HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_2_"  (2)  In this context, the "Sc" superscript is used to designate
the scrapie-like isoform of PrP.

A chromosomal gene encodes PrP and no PrP genes are found in purified
preparations of prions. PrPSc is derived from PrPC (the cellular isoform
of PRP) by a posttranslational process whereby PrPSc acquires a high
-sheet content.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_3_"  (3)
Neither prion-specific nucleic acids nor virus-like particles have been
detected in purified, infectious preparations. In fungi, evidence for
three different prions has been accumulated.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_4_"  (4)

The mammalian prions cause scrapie and other related neurodegenerative
diseases of humans and animals (Table 6). The prion diseases are also
referred to as the transmissible spongiform encephalopathies (TSEs).
HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_5_"  (5)

Table 1. The Prion Diseases

Disease abbreviation)

Natural Host

Prion

Pathogenic PrP Isoform

Scrapie

sheep and goats

scrapie prion

OvPrPSc

Transmissible mink encephalopathy (TME)

mink

TME prion

MkPrPSc

Chronic wasting disease (CWD)

mule deer and elk

CWD prion

MdePrPSc

Bovine spongiform encephalopathy (BSE)

cattle

BSE prion

BoPrPSc

Feline spongiform encephalopathy (FSE)

cats

FSE prion

FePrPSc

Exotic ungulate encephalopathy (EUE)

nyala and greater kudu

EUE prion

UngPrPSc

Kuru

humans

kuru prion

HuPrPSc

Creutzfeldt-Jakob disease (CJD)

humans

CJD prion

HuPrPSc

Gerstmann-Sträussler-Scheinker syndrome (GSS)

humans

GSS prion

HuPrPSc

Gatal familial insomnia (FFI)

humans

FFI prion

HuPrPSc

Species-specificity of prions. Unlike many viruses, the properties of
prions change dramatically when they are passaged from one species to
another. The results of transgenic (Tg) mouse studies indicate that when
human prions are passaged into mice, their potential non-Tg
pathogenicity for humans probably declines drastically.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_6_"  (6)
The prions that are propagated in the non-Tg mice are now mouse prions,
not human prions. The mouse prions contain mouse PrPSc, not human PrPSc.
This species-specific change in the PrPSc molecule is accompanied by an
alteration in the pathogenicity of the prion. In contrast to the human
prions, mouse prions are highly pathogenic for mice. Our understanding
of these species-specific changes in prion pathogenicity is derived
largely from studies of mice expressing a variety of PrP transgenes.
Because the PrPSc produced in the mouse is from mouse PrPC, it not
possible to determine the origin of the prion initially inoculated into
the mouse.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_7_"  (7)

It is noteworthy that the susceptibility of a particular species to
prions from another species can be profoundly affected by different
prion strains.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_8_"  (8)
The properties manifested by prion strains such as incubation times and
neuropathology profiles seem to be enciphered in the conformation of
PrPSc.

Such considerations of the basic principles of prion biology help to
form the basis for the biosafety classification of different prions.

Biosafety level classification. Human prions and those propagated in
apes and monkeys are manipulated at Biosafety Level 2 or 3, depending on
the studies being conducted. BSE prions are likewise manipulated at
Biosafety Level 2 or 3, due to the possibility that BSE prions have been
transmitted to humans in Great Britain and France.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_9_"  (9)

All other animal prions are considered Biosafety Level 2 pathogens.
Thus, based on our current understanding of prion biology described
above, once human prions are passaged in mice and mouse PrPSc is
produced, these prions should be considered Biosafety Level 2 prions,
even though the human prions are Biosafety Level 3 under most
experimental conditions. An exception to this statement is in the case
of mice expressing human or chimeric human/mouse transgenes. These
transgenic mice produce human prions when infected with human prions and
should be treated as Biosafety Level 2 or 3 in accord with the
guidelines described above. The mechanism of prion spread among sheep
and goats developing natural scrapie is unknown.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_10_"  (10)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_11_"  (11)  CWD, TME, BSE, FSE, and EUE are all thought to occur
after the consumption of prion-infected foods.   HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_12_"  (12)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_13_"  (13)   HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_14_"  (14)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_15_"  (15)

Human prion diseases. In the care of patients dying of human prion
disease, the precautions used for patients with AIDS or hepatitis are
certainly adequate. In contrast to these viral illnesses, the human
prion diseases are not communicable or contagious.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_16_"  (16)
There is no evidence of contact or aerosol transmission of prions from
one human to another. However, they are infectious under some
circumstances, such as ritualistic cannibalism in New Guinea causing
kuru, the administration of prion-contaminated growth hormone causing
iatrogenic CJD, and the transplantation of prion-contaminated dura mater
grafts.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_17_"  (17)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_18_"  (18)   HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_19_"  (19)
Familial CJD, GSS, and FFI are all dominantly inherited prion diseases;
five different mutations of the PrP gene have been shown to be
genetically linked to the development of inherited prion disease. Prions
from many cases of inherited prion disease have been transmitted to
apes, monkeys, and mice carrying human PrP transgenes.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_20_"  (20)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_21_"  (21)   HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_22_"  (22)

Surgical procedures. Surgical procedures on patients diagnosed with
prion disease should be minimized. It is thought that CJD has been
spread from a CJD patient to two other patients who underwent
neurosurgical procedures in the same operating theater shortly
thereafter.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_23_"  (23)
Although there is no documentation of the transmission of prions to
humans through droplets of blood or cerebrospinal fluid, or by exposure
to intact skin, or gastric and mucous membranes, the risk of such
occurrences is a possibility. Sterilization of the instruments and
decontamination of the operating room should be performed in accordance
with recommendations described below.

Because it is important to establish a 'definitive' diagnosis of a human
prion disease and to distinguish between sporadic and familial cases and
those acquired by infection as a result of medical procedures or from
prion-contaminated food products, unfixed brain tissue should be
obtained. For all cases of suspected human prion disease, a minimum of
one cubic centimeter of unfixed cerebral cortex should be part of any
biopsy. This specimen should be bisected from the cortical surface
through to the underlying white matter with one half of the specimen
formalin-fixed and the other half frozen.

Autopsies. Routine autopsies an-d the processing of small amounts of
formalin-fixed tissues containing human prions require Biosafety Level 2
precautions.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_24_"  (24)
At autopsy, the entire brain should be collected and cut into coronal
sections about 1.5 inches (~4 cm) thick; small blocks of tissue can
easily be removed from each coronal section and placed in fixative for
subsequent histopathologic analyses. Each coronal section is immediately
heat sealed in a heavy-duty plastic bag. The outside of this bag is
assumed to be contaminated with prions and other pathogens. With fresh
gloves or with the help of an assistant with uncontaminated gloves, the
bag containing the specimen is placed into another plastic bag which
does not have a contaminated outer surface. The samples should then be
frozen on dry ice or placed directly in a -70C freezer for storage. At
the very minimum, a coronal section of cerebral hemisphere containing
the thalamus and one of the cerebellar hemisphere and brainstem should
be taken and frozen.

The absence of any known effective treatment for prions disease demands
caution. The highest concentrations of prions are in the central nervous
system and its coverings. Based on animal studies, it is likely that
high concentrations of prions are also found in spleen, thymus, lymph
nodes, and lung. The main precaution to be taken when working with
prion-infected or contaminated material is to avoid puncture of the
skin.  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm"
\l "N_25_"  (25)  The prosector should wear cut-resistant gloves if
possible. If accidental contamination of skin occurs, the area is
swabbed with 1N sodium hydroxide for 5 minutes and then washed with
copious amounts of water. Tables 2-5 provide guidelines to reduce the
chance of skin punctures, aerosols, and contamination of operating room,
morgue surfaces and instruments. Unfixed samples of brain, spinal cord,
and other tissues containing human prions should be processed with
extreme care at Biosafety Level 3.

Bovine spongiform encephalopathy. The risk of infection for humans by
BSE prions is unclear. Perhaps the most prudent approach is to study BSE
prions in a Biosafety Level 2 or 3 facility depending on the samples to
be studied, as noted above for human prions (i.e., brain, spinal cord).

Experimental rodent prion diseases. Mice and hamsters are the
experimental animals of choice for all studies of prion disease. With
the development of transgenic mice that are highly susceptible to human
prions, the use of apes and monkeys is rarely needed. The highest titers
of prions (~109.5 ID50/g) are found in the brain and spinal cord of
laboratory rodents infected with adapted strains of prions;  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_26_"  (26)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_27_"  (27)  lower titers (~106 ID50/g) are present in the spleen and
lymphoreticular system.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_28_"  (28)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_29_"  (29)

Physical properties of prions. The smallest infectious prion particle is
probably a dimer of PrPSc; this estimate is consistent with an ionizing
radiation target size of 55 ±9 kDa.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_30_"  (30)
Therefore, prions may not be retained by most of the filters that
efficiently eliminate bacteria and viruses. Additionally, prions
aggregate into particles of non-uniform size and cannot be solubilized
by detergents, except under denaturing conditions where infectivity is
lost.  HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm"
\l "N_31_"  (31)   HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_32_"  (32)
Prions resist inactivation by nucleases,  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_33_"  (33)
UV-irradiation at 254 nm,  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_34_"  (34)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_35_"  (35)  and treatment with psoralens,  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_36_"  (36)
divalent cations, metal ion chelators, acids (between pH 3 and 7),
hydroxylamine, formalin, boiling, or proteases.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_37_"  (37)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_38_"  (38)

Inactivation of prions. Prions are characterized by extreme resistance
to conventional inactivation procedures including irradiation, boiling,
dry heat, and chemicals (formalin, betapropiolactone, alcohols). While
prion infectivity in purified samples is diminished by prolonged
digestion with proteases,  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_39_"  (39)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_40_"  (40) results from boiling in sodium dodecyl sulfate and urea
are variable. Sterilization of rodent brain extracts with high titers of
prions requires autoclaving at 132C for 4.5 hours (h). Denaturing
organic solvents such as phenol or chaotropic reagents such as guanidine
isothiocyanate or alkali such as NaOH can also be used for
sterilization.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_41_"  (41)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_42_"  (42)   HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_43_"  (43)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_44_"  (44)   HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_45_"  (45)
Prions are inactivated by 1N NaOH, 4.0 M guanidinium hydrochloride or
isocyanate, sodium hypochlorite (2% free chlorine concentration), and
steam autoclaving at 132C for 4.5 h.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_46_"  (46)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_47_"  (47)   HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_48_"  (48)
 HYPERLINK "http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l
"N_49_"  (49)  It is recommended that dry waste be autoclaved at 132C
for 4.5 h or incinerated. Large volumes of infectious liquid waste
containing high titers of prions can be completely sterilized by
treatment with 1N NaOH (final concentration) or autoclaving at 132C for
4.5 h. Disposable plasticware, which can be discarded as a dry waste, is
highly recommended. Because the paraformaldehyde vaporization procedure
does not diminish prion titers, the biosafety cabinets must be
decontaminated with 1N NaOH, followed by 1N HCl, and rinsed with water.
HEPA filters should be autoclaved and incinerated.

Although there is no evidence to suggest that aerosol transmission
occurs in the natural disease, it is prudent to avoid the generation of
aerosols or droplets during the manipulation of tissues or fluids and
during the necropsy of experimental animals. It is further strongly
recommended that gloves be worn for activities that provide the
opportunity for skin contact with infectious tissues and fluids.
Formaldehyde-fixed and paraffin-embedded tissues, especially of the
brain, remain infectious. Some investigators recommend that
formalin-fixed tissues from suspected cases of prion disease be immersed
for 30 min in 96% formic acid or phenol before histopathologic
processing,  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_50_"  (50)
but such treatment may severely distort the microscopic neuropathology.

Handling and processing of tissues from patients with suspected prion
disease. The special characteristics of work with prions require
particular attention to the facilities, equipment, policies, and
procedures involved. The related considerations outlined in the
following tables should be incorporated into the laboratory's risk
management for this work.

Table 2. Standard precautions* for autopsies of patients with suspected
prion disease

*Not to be confused with "Standard Universal Precautions"

1. Attendance should be limited to at least one experienced pathologist
and minimal staff. One of the staff avoids direct contact with the
deceased but assists with handling of instruments and specimen
containers.

2. Standard autopsy attire is mandatory.

a. A disposable, waterproof gown is worn in place of a cloth gown.

b. Cut-resistant gloves are worn underneath two pairs of surgical gloves
or chain mail gloves are worn between two pairs of surgical gloves.

c. Aerosols are mainly created during opening of the skull with a
Stryker saw. Appropriate respiratory protection should be worn (i.e.,
PAPR).

3. To reduce contamination of the autopsy suite:

a. The autopsy table is covered with an absorbent sheet that has a
waterproof backing.

b. Contaminated instruments are placed on an absorbent pad.

c. The brain is removed while the head is in a plastic bag to reduce
aerosolization and splatter.

d. The brain can be placed into a container with a plastic bag liner for
weighing.

e. The brain is placed onto a cutting board and appropriate samples are
dissected for snap freezing (see Table 4).

f. The brain or organs to be fixed are immediately placed into a
container with 10% neutral buffered formalin.

g. In most cases of suspected prion disease, the autopsy can be limited
to examination of the brain only. In cases requiring a full autopsy,
consideration should be given to examining and sampling of thoracic and
abdominal organs in situ.

Table 3. Autopsy suite decontamination procedures

1. Instruments (open box locks and jaws) and saw blades are placed into
a large stainless steel dish, soaked for 1 h in 2N sodium hydroxide or 2
h in 1N sodium hydroxide, and then rinsed well in water before
autoclaving at 134C (gravity displacement steam autoclaving for 1 h;
porous load steam autoclaving for one 18-minute cycle at 30 lbs psi or
six 3-minute cycles at 30 lbs psi).

2. The Stryker saw is cleaned by repeated wetting with 2N sodium
hydroxide solution over a 1 h period. Appropriate washing to remove
residual NaOH is required.

3. The absorbent table cover and instrument pads, disposable clothing,
etc. are double bagged in appropriate infectious waste bags for
incineration.

4. Any suspected areas of contamination of the autopsy table or room are
decontaminated by repeated wetting over 1 h with 2N sodium hydroxide

Table 4. Brain cutting procedures

1. After adequate formaldehyde fixation (at least 10-14 days), the brain
is examined and cut on a table covered with an absorbent pad with an
impermeable backing.

2. Samples for histology are placed in cassettes labeled with "CJD
precautions." For laboratories that do not have embedding and staining
equipment or microtome dedicated to infectious diseases including CJD,
blocks of formalin-fixed tissue can be placed in 96% absolute formic
acid for 30 minutes, followed by fresh 10% neutral buffered formalin
solution for at least 48 h.  HYPERLINK
"http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s7d.htm" \l "N_51_"  (51)
The tissue block is then embedded in paraffin as usual. Standard
neurohistological or immunohistochemical techniques are not obviously
affected by formic acid treatment; however, in our experience, tissue
sections are brittle and crack during sectioning.

3. All instruments and surfaces coming in contact with the tissue are
decontaminated as described in Table 3.

4. Tissue remnants, cutting debris, and contaminated formaldehyde
solution should be discarded within a plastic container as infectious
hospital waste for eventual incineration.

Table 5. Tissue preparation

1. Histology technicians wear gloves, apron, laboratory coat, and face
protection.

2. Adequate fixation of small tissue samples (e.g. biopsies) from a
patient with suspected prion disease is followed by post-fixation in 96%
absolute formic acid for 30 minutes, followed by 48 hours in fresh 10%
formalin.

3. Liquid waste is collected in a 4L waste bottle containing 600 ml 6N
sodium hydroxide.

4. Gloves, embedding molds, and all handling materials are disposed of
as biohazardous waste.

5. Tissue cassettes are processed manually to prevent contamination of
tissue processors.

6. Tissues are embedded in a disposable embedding mold. If used, forceps
are decontaminated.

7. In preparing sections, gloves are worn, section waste is collected
and disposed of in a biohazard waste receptacle. The knife stage is
wiped with 1-2N NaOH, and the knife used is discarded immediately in a
"biohazard sharps" receptacle. Slides are labeled with "CJD
Precautions." The sectioned bloc is sealed with paraffin.

8. Routine staining:

a. Slides are processed by hand.

b. Reagents are prepared in 100 ml disposable specimen cups.

c. After placing the coverslip on, slides are decontaminated by soaking
them for 1 h in 2N NaOH.

d. Slides are labeled as "Infectious-CJD."

9. Other suggestions:

a. Disposable specimen cups or slide mailers may be used for reagents.

b. Slides for immunocytochemistry may be processed in disposable petri
dishes.

c. Equipment is decontaminated as described above.

References

1. Prusiner S.B. 1997. Prion diseases and the BSE crisis. Science
278:245-251.

2. Prusiner S.B., Baron H., Carlson G., Cohen F.E., DeArmond S.J.,
Gabizon R., Gambetti P., Hope J., Kitamoto T., Kretzschmar H.A.,
Laplanche J.-L., Tateishi J., Telling G., Weissmann C., Will R., In
press. "Prions." In: Virus Taxonomy. 7th Report of the International
Committee on Taxonomy of Viruses. Academic Press.

3. Pan K.-M., Baldwin M., Nguyen J., Gasset M., Serban A., Groth D.,
Mehlhorn I., Huang Z., Fletterick R.J., Cohen F.E., Prusiner S.B. 1993.
Conversion of -helices into -sheets features in the formation of the
scrapie prion proteins. Proc Natl Acad Sci USA 90:10962-10966.

4. Wickner R.B. 1997. A new prion controls fungal cell fusion
incompatibility [Commentary]. Proc Natl Acad Sci USA 94:10012-10014.

5. Gajdusek, D.C. 1977. Unconventional viruses and the origin and
disappearance of kuru. Science 197:943-960.

6. Telling G.C., Scott M., Mastrianni J., Gabizon R., Torchia M., Cohen
F.E., DeArmond S.J., Prusiner S.B. 1995. Prion propagation in mice
expressing human and chimeric PrP transgenes implicates the interaction
of cellular PrP with another protein. Cell 83:79-90.

7. Prusiner S.B. 1997 (1)

8. Prusiner S.B. 1997 (1)

9. Will R.G., Ironside J.W., Zeidler M., Cousens S.N., Estibeiro K.,
Alperovitch A., Poser S., Pocchiari M., Hofman A., Smith P.G. 1996. A
new variant of Creutzfeldt-Jakob disease in the UK. Lancet 347:921-925.

10. Foster J.D., McKelvey W.A.C., Mylne M.J.A., Williams A., Hunter N.,
Hope J., Fraser H. 1992. Studies on maternal transmission of scrapie in
sheep by embryo transfer. Vet Rec 130:341-343.

11. Dickinson A.G., Stamp J.T., Renwick C.C. 1974. Maternal and lateral
transmission of scrapie in sheep. J Comp Pathol 84:19-25.

12. Prusiner S.B. 1997 (1)

13. Gajdusek D.C. 1991. The transmissible amyloidoses: genetical control
of spontaneous generation of infectious amyloid proteins by nucleation
of configurational change in host precursors: kuru-CJD-GSS-scrapie-BSE.
Eur J Epidemiol 7:567-577.

14. Marsh R.F., 1992. "Transmissible mink encephalopathy." In: Prion
Diseases of Humans and Animals. Prusiner S.B., Collinge J., Powell J.,
Anderton B., Eds. Ellis Horwood, London, pp. 300-307.

15. Collinge J., Palmer M.S., 1997. "Human prion diseases." In: Prion
Diseases. Collinge J., Palmer M.S., Eds. Oxford University Press,
Oxford, U.K., pp. 18-56.

16. Ridley R.M., Baker H.F. 1993. Occupational risk of Creutzfeldt-Jakob
disease. Lancet 341:641-642.

17. Gajdusek D.C. 1977 (5)

18. Public Health Service Interagency Coordinating Committee. 1997.
Report on Human Growth Hormone and Creutzfeldt-Jakob Disease. 14:1-11.

19. CDC. 1997. Creutzfeldt-Jakob disease associated with cadaveric dura
mater grafts - Japan, January 1979-May 1996. MMWR 46:1066-1069.

20. Telling G.C., et al. 1995. (6)

21. Brown P., Gibbs C.J., Jr., Rodgers-Johnson P., Asher D.M., Sulima
M.P., Bacote A., Goldfarb L.G., Gajdusek D.C. 1994. Human spongiform
encephalopathy: the National Institutes of Health series of 300 cases of
experimentally transmitted disease. Ann Neurol 35:513-529.

22. Telling G.C., Parchi P., DeArmond S.J., Cortelli P., Montagna P.,
Gabizon R., Mastrianni J., Lugaresi E., Gambetti P., Prusiner S.B. 1996.
Evidence for the conformation of the pathologic isoform of the prion
protein enciphering and propagating prion diversity. Science
274:2079-2082.

23. Brown P., Preece M.A., Will R.G. 1992. "Friendly fire" in medicine:
hormones, homografts, and Creutzfeldt-Jakob disease. Lancet 340:24-27.

24. Ironside J.W., Bell J.E. 1996. The 'high-risk' neuropathological
autopsy in AIDS and Creutzfeldt-Jakob disease: principles and practice.
Neuropathol Appl Neurobiol 22:388-393.

25. Ridley R.M., Baker H.F. 1993. (16)

26. Eklund C.M., Kennedy R.C., Hadlow W.J. 1967. Pathogenesis of scrapie
virus infection in the mouse. J Infect Dis 117:15-22.

27. Prusiner S.B., Groth D.F., Cochran S.P., Masiarz F.R., McKinley
M.P., Martinez H.M. 1980. Molecular properties, partial purification,
and assay by incubation period measurements of the hamster scrapie
agent. Biochemistry 19:4883-4891.

28. Prusiner S.B., Hadlow W.J., Eklund C.M., Race R.E., Cochran S.P.
1978. Sedimentation characteristics of the scrapie agent from murine
spleen and brain. Biochemistry 17:4987-4992.

29. Kimberlin R.H. 1976. Scrapie in the Mouse . Meadowfield Press,
Durham, England.

30. Bellinger-Kawahara C.G., Kempner E., Groth D.F., Gabizon R.,
Prusiner S.B. 1988. Scrapie prion liposomes and rods exhibit target
sizes of 55,000 Da. Virology 164:537-541.

31. - Gabizon R., Prusiner S.B. 1990. Prion liposomes. Biochem J
266:1-14.

32. Safar J., Ceroni M., Piccardo P., Liberski P.P., Miyazaki M.,
Gajdusek D.C., Gibbs C.J., Jr. 1990. Subcellular distribution and
physicochemical properties of scrapie associated precursor protein and
relationship with scrapie agent. Neurology 40:503-508.

33. Bellinger-Kawahara C., Diener T.O., McKinley M.P., Groth D.F., Smith
D.R., Prusiner S.B. 1987. Purified scrapie prions resist inactivation by
procedures that hydrolyze, modify, or shear nucleic acids. Virology
160:271-274.

34. Alper T., Cramp W.A., Haig D.A., Clarke M.C. 1967. Does the agent of
scrapie replicate without nucleic acid? Nature 214:764-766.

35. Bellinger-Kawahara C., Cleaver J.E., Diener T.O., Prusiner S.B.
1987. Purified scrapie prions resist inactivation by UV irradiation. J
Virol 61:159-166.

36. McKinley M.P., Masiarz F.R., Isaacs S.T., Hearst J.E., Prusiner S.B.
1983. Resistance of the scrapie agent to inactivation by psoralens.
Photochem Photobiol 37:539-545.

37. Prusiner S.B. 1982. Novel proteinaceous infectious particles cause
scrapie. Science 216:136-144.

38. Brown P., Wolff A., Gajdusek D.C. 1990. A simple and effective
method for inactivating virus infectivity in formalin-fixed samples from
patients with Creutzfeldt-Jakob disease. Neurology 40:887-890.

39. Prusiner S.B., McKinley M.P., Groth D.F., Bowman K.A., Mock N.I.,
Cochran S.P., Masiarz F.R. 1981. Scrapie agent contains a hydrophobic
protein. Proc Natl Acad Sci USA 78:6675-6679.

40. McKinley M.P., Bolton D.C., Prusiner S.B. 1983. A protease-resistant
protein is a structural component of the scrapie prion. Cell 35:57-62.

41. Prusiner S.B., Groth D.F., McKinley M.P., Cochran S.P., Bowman K.A.,
Kasper K.C. 1981. Thiocyanate and hydroxyl ions inactivate the scrapie
agent. Proc Natl Acad Sci USA 78:4606-4610.

42. Prusiner S.B., McKinley M.P., Bolton D.C., Bowman K.A., Groth D.F.,
Cochran S.P., Hennessey E.M., Braunfeld M.B., Baringer J.R., Chatigny
M.A., 1984. "Prions: methods for assay, purification and
characterization." In: Methods in Virology. Maramorosch K., Koprowski
H., Eds. Academic Press, New York, pp. 293-345.

43. Prusiner S.B., Groth D., Serban A., Stahl N., Gabizon R. 1993.
Attempts to restore scrapie prion infectivity after exposure to protein
denaturants. Proc Natl Acad Sci USA 90:2793-2797.

44. Taylor D.M., Woodgate S.L., Atkinson M.J. 1995. Inactivation of the
bovine spongiform encephalopathy agent by rendering procedures. Vet Rec
137:605-610.

45. Taylor D.M., Woodgate S.L., Fleetwood A.J., Cawthorne R.J.G. 1997.
Effect of rendering procedures on the scrapie agent. Vet Rec
141:643-649.

46. Prusiner, S.B., et al. 1984. (42)

47. Prusiner, S.B. et al. 1993. (43)

48. Taylor D.M., Woodgate S.L., Atkinson M.J. 1995. (44)

49. Taylor, D.M. et al. 1997. (45)

50. Brown P., Wolff A., Gajdusek D.C. 1990. (38)

51. Brown P., Wolff A., Gajdusek D.C. 1990. (38)


[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Proposed Rules]
[Pages 5454-5456]
[FR Doc No: 2017-00890]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0755; Directorate Identifier 2010-NE-12-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: We propose to supersede airworthiness directive (AD) 2012-04-
01 that applies to all Rolls-Royce plc (RR) RB211-Trent 800 model
turbofan engines. AD 2012-04-01 requires removal from service of
certain critical engine rotating parts based on reduced life limits.
Since we issued AD 2012-04-01, RR has further revised the life limits
of certain critical engine rotating parts. This proposed AD would make
additional revisions to the life limits of certain critical engine
rotating parts. We are proposing this AD to correct the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by March 6, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2010-
0755; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket

contains this proposed AD, the mandatory continuing airworthiness
information, regulatory evaluation, any comments received, and other
information. The address for the Docket Office (phone:<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Robert Green, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 1200
District Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: 781-
238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0755;
Directorate Identifier 2010-NE-12-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On February 10, 2012, we issued AD 2012-04-01, Amendment 39-16956
(77 FR 10355, February 22, 2012), ``AD 2012-04-01,'' for all RR RB211-
Trent 800 model turbofan engines. AD 2012-04-01 requires removal from
service of certain critical engine rotating parts based on reduced life
limits. AD 2012-04-01 resulted from RR reducing the life limits of
certain critical engine rotating parts. We issued AD 2012-04-01 to
prevent the failure of critical engine rotating parts, which could
result in damage to the engine and damage to the airplane.

Actions Since AD 2012-04-01 Was Issued

    Since we issued AD 2012-04-01, RR has reduced the life limit of two
affected critical engine rotating parts and extended the life of an
additional critical engine rotating part. Also since we issued AD 2012-
04-01, the European Aviation Safety Agency (EASA) has issued AD 2016-
0223, dated November 8, 2016, which imposes new life limits on certain
critical engine rotating parts.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require replacement of certain critical
engine rotating parts at a newer, lower life limit. This proposed AD
would also extend the life limit for an additional critical engine
rotating part.

Costs of Compliance

    We estimate that this proposed AD affects 16 engines installed on
airplanes of U.S. registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                     Labor cost            Parts cost           product         operators
----------------------------------------------------------------------------------------------------------------
Replacement of critical engine      0 work-hours x $85    $45,000 (pro-rated           $45,000         $720,000
 rotating parts.                     per hour = $0.        cost of parts).
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2012-04-01, Amendment 39-16956 (77 FR 10355, February 22, 2012), and
adding the following new AD:

Rolls-Royce plc: Docket No. FAA-2010-0755; Directorate Identifier
2010-NE-12-AD.

(a) Comments Due Date

    We must receive comments by March 6, 2017.

(b) Affected ADs

    This AD supersedes AD 2012-04-01, Amendment 39-16956 (77 FR
10355, February 22, 2012).

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR) RR RB211-Trent 875-
17, 877-17, 884-17, 884B-17, 892-17, 892B-17, and 895-17 turbofan
engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7200, Engine
(Turbine/Turboprop).

(e) Unsafe Condition

    This AD was prompted by RR revising the life limits of certain
critical engine rotating parts. We are issuing this AD to prevent
the failure of critical engine rotating parts, damage to the engine,
and damage to the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) After the effective date of this AD, remove from service the
parts listed in Table 1 to paragraph (f) of this AD before exceeding
the new life limit indicated:

                                  Table 1 to Paragraph (f)--Reduced Part Lives
----------------------------------------------------------------------------------------------------------------
                                                                                Life in     Life in cycles
                        Part nomenclature                            Part No.      standard duty     using the
                                                                                cycles       HEAVY profile
----------------------------------------------------------------------------------------------------------------
Intermediate Pressure (IP) Compressor Rotor Shaft...............         FK24100          12,500          11,500
IP Compressor Rotor Shaft.......................................         FK24496           8,860           8,180
High-Pressure Compressor (HPC) Stage 1 to 4 Rotor Discs Shaft...         FK24009           4,560           4,460
HPC Stage 1 to 4 Rotor Discs Shaft..............................         FK26167           5,580           5,280
HPC Stage 1 to 4 Rotor Discs Shaft..............................         FK32580           5,580           5,280
HPC Stage 1 to 4 Rotor Discs Shaft..............................         FW11590           8,550           6,850
HPC Stage 1 to 4 Rotor Discs Shaft..............................         FW61622           8,550           6,850
HPC Stage 5 and 6 Discs and Cone................................         FK25230           5,000           5,000
HPC Stage 5 and 6 Discs and Cone................................         FK27899           5,000           5,000
IP Turbine Rotor Disc...........................................         FK21117          11,610          10,400
IP Turbine Rotor Disc...........................................         FK33083               0               0
----------------------------------------------------------------------------------------------------------------

    (2) Reserved.

(g) Installation Prohibition

    After the effective date of this AD, do not install any IP
turbine discs, P/N FK33083, into any engine.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(i) Related Information

    (1) For more information about this AD, contact Robert Green,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency, AD 2016-0223,
dated November 8, 2016, for more information. You may examine the
MCAI in the AD docket on the Internet at http://www.regulations.gov
by searching for and locating it in Docket No. FAA-2010-0755.

    Issued in Burlington, Massachusetts, on January 11, 2017.
Colleen M. D'Alessandro,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2017-00890 Filed 1-17-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49879-49880]
[FR Doc No: 2017-23370]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81917; File No. SR-NASDAQ-2017-111]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Exchange's Name Change

October 23, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 18, 2017, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its rules as well as certain
corporate documents of the Exchange to reflect legal name changes.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to reflect in the Exchange's
governing documents (and the governing documents of its parent company)
\3\ and the Exchange's Rulebook a non-substantive corporate branding
change to the Exchange's name.\4\ Specifically, current references will
be changed as follows:
---------------------------------------------------------------------------

    \3\ The Exchange proposes to amend: (i) The Certificate of
Formation; (ii) Second Amended Limited Liability Company Agreement;
(iii) By-Laws; and (iv) Rule Book.
    \4\ NASDAQ PHLX LLC and NASDAQ BX, Inc. will also be filing
similar rule changes.

 References to ``NASDAQ'' will be changed to ``Nasdaq''
 References to ``The NASDAQ Stock Market LLC'' or ``NASDAQ
Stock Market LLC'' will be changed to ``The Nasdaq Stock Market LLC''
 References to ``NASDAQ PHLX LLC'' or ``NASDAQ PHLX'' will be
changed to ``Nasdaq PHLX LLC'' or ``Nasdaq PHLX''
 References to ``NASDAQ BX, Inc.'' or ``NASDAQ BX'' will be
changed to ``Nasdaq BX, Inc.'' or ``Nasdaq BX''
 References to ``NASDAQ OMX PSX'' or ``NASDAQ PSX'' will be
changed to ``Nasdaq PSX''
 References to ``The NASDAQ OMX Group, Inc.'' or ``NASDAQ OMX
Group, Inc.'' will be changed to ``Nasdaq, Inc'' \5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 75421 (July 10,
2015), 80 FR 42136 (July 16, 2015) (SR-BSECC-2015-001, SR-BX-2015-
030, SR-NASDAQ-2015-058, SR-Phlx-2015-46, SR-SCCP-2015-01).

     In addition to the preceding changes, all references to
``OMX'' will be removed from the Rulebook.\6\
---------------------------------------------------------------------------

    \6\ Id.

 References to ``NASDAQ Options Market LLC'' will be replaced
with ``The Nasdaq Options Market LLC''
 References to ``NASDAQ Execution Services, LLC'' will be
changed to ``Nasdaq Execution Services, LLC''

     In all instances where the word ``the'' should have been
capitalized, (e.g., Rule 4758(b)(1)), the Exchange will make the
appropriate correction.
    No other changes are being proposed in this filing. The Exchange
represents that these changes are concerned solely with the
administration of the Exchange and do not affect the meaning,
administration, or enforcement of any rules of the Exchange or the
rights, obligations, or privileges of Exchange members or their
associated persons in any way. Accordingly, this filing is being
submitted under Rule 19b-4(f)(3). In lieu of providing a copy of the
marked changes, the Exchange represents that it will make the necessary
non-substantive revisions to the Certificate of Formation, Second
Amended Limited Liability Company Agreement, By-Laws, the Rulebook and
post updated versions of each on the Exchange's Web site pursuant to
Rule 19b-4(m)(2).
    The Exchange notes that the following references are not being
amended in the Exchange's governing documents and the Exchange's
Rulebook:
     Any name with a trademark (TM) or service mark (SM)
attached to the name.
     Any references in the Certificate of Formation or Second
Amended Limited Liability Company Agreement which references [sic] a
prior name of the Exchange and reflects [sic] a historical date wherein
that name was in effect.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\7\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest by
avoiding confusion with the name. The Exchange proposes to conform its
name to that of its parent, Nasdaq Inc., by changing the capitalization
in the word ``NASDAQ'' to ``Nasdaq.'' The Exchange also proposes to
amend the names of affiliated markets in a similar manner, by changing
the name ``NASDAQ'' to ``Nasdaq.'' The name change of the Exchange as
well as other name changes

to related entities are non-substantive changes. No changes to the
ownership or structure of the Exchange have taken place.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The name change will align with
the parent company, Nasdaq, Inc.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(3)
thereunder,\10\ the Exchange has designated this proposal as one that
is concerned solely with the administration of the self-regulatory
organization, and therefore has become effective.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NASDAQ-2017-111 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2017-111. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2017-111, and should
be submitted on or before November 17, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-23370 Filed 10-26-17; 8:45 am]
BILLING CODE 8011-01-P