[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58328-58332]
[FR Doc No: 2013-23114]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-0499]

Change-1 to Navigation and Inspection Circular 04-08

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability.

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SUMMARY: The Coast Guard announces the availability of Change-1 to
Navigation and Vessel Inspection Circular 04-08, ``Medical and Physical
Evaluation Guidelines for Merchant Mariner Credentials'' (NVIC 04-08).
Change-1 to NVIC 04-08 contains a summary and clarification of Coast
Guard policies regarding the criteria for granting medical waivers to
merchant mariner credential applicants who have had either anti-
tachycardia devices or implantable cardioverter defibrillators
implanted, and to applicants who have had a seizure. This notice also
addresses comments we received in response to Coast Guard notices
published in the Federal Register on September 7, 2012, and March 25,
2013 soliciting public comments on these issues.

DATES: Change-1 to NVIC 04-08 is effective on September 23, 2013.

ADDRESSES: NVIC 04-08 is available in the docket and can be viewed by
going to http://www.regulations.gov and using ``USCG-2013-0499'' as
your search term. Locate this notice in the search results. NVIC 04-08
is available by clicking the ``Supporting Documents'' link. NVIC 04-08
is also available on the Coast Guard's Web site at: www.uscg.mil/nmc.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Ashley Holm, Office of Commercial Vessel
Compliance (CG-CVC),<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you
have questions on viewing or submitting material to the docket, call
Barbara Hairston, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION:

I. Background and Purpose

General Waiver Criteria

    Coast Guard regulations in 46 CFR 10.215 contain the medical
standards that merchant mariner applicants must meet prior to being
issued a merchant mariner credential (MMC). In cases where the
applicant does not meet the medical standards in 46 CFR 10.215, the
Coast Guard may issue a waiver when extenuating circumstances exist
that warrant special consideration (see 46 CFR 10.215(g)).

Anti-Tachycardia Devices and Implantable Cardioverter Defibrillators

    Coast Guard guidance in NVIC 04-08 provides that anti-tachycardia
devices and implantable cardioverter defibrillators (ICDs) are
generally not waiverable. Prior to issuing Change-1 to NVIC 04-08,
Coast Guard guidance did not identify waiver criteria associated with
anti-tachycardia devices or ICDs, rendering it difficult for Coast
Guard personnel to consistently evaluate merchant mariner applicants
with anti-tachycardia devices or ICDs, and assess whether an
applicant's medical condition warranted granting a medical waiver under
46 CFR 10.215(g). Enclosure (7) to NVIC 04-08 now provides guidelines
to use when assessing an applicant's eligibility for a waiver.
    On September 7, 2012 we published a notice in the Federal Register
requesting public comments on this issue (77 FR 55174). On December 17,
2012, we re-opened and extended the public comment period for an
additional 30 days to provide additional opportunity to comment (77 FR
74630). We summarize the policy in Enclosure (7) to NVIC 04-08 and
address the public comments below.

Seizures

    Coast Guard regulations in 46 CFR 10.215(d) state that a convulsive
disorder (i.e., seizure disorder) could lead to an applicant's
disqualification from receiving a credential. Prior to issuing Change-1
to NVIC 04-08, Coast Guard guidance did not identify waiver criteria
associated with applicants that had a history of seizures rendering it
difficult for Coast Guard personnel to consistently evaluate merchant
mariner applicants with seizures and assess whether an applicant's
medical condition warranted granting a medical waiver under 46 CFR
10.215(g). Enclosure (8) to NVIC 04-08 now provides guidelines to use
when assessing an applicant's eligibility for a waiver.
    On March 25, 2013 we published a notice in the Federal Register
requesting public comments on this issue (78 FR 17917). We summarize
the policies in Enclosure (8) to NVIC 04-08 and address the public
comments below.

II. Discussion

ICD Policy

    Prior to Change-1, NVIC 04-08 referred applicants to the Coast
Guard's National Maritime Center (NMC) for guidance on the treatment of
ICDs. ICDs were generally not waiverable. Enclosure (7) provides a list
of criteria to be considered when evaluating an application from a
mariner with an ICD. While the policy remains that ICDs are generally
not waiverable, the criteria in Enclosure (7) will identify those
limited situations where a waiver will be considered. The criteria that
must be met to be considered for a waiver are:
    (1) The applicant does not have a diagnosis of a cardiac
channelopathy affecting the electrical conduction of the heart (to
include Brugada syndrome, Long QT syndrome, etc.);
    (2) The applicant does not have a prior history of ventricular
fibrillation or episodes of sustained ventricular tachycardia within
the last three years;
    (3) The ICD or anti-tachycardia device was implanted more than
three years ago;
    (4) The ICD has not fired nor has the applicant required anti-
tachycardia pacing therapy within the last three years;
    (5) There are no additional risk factors for inappropriate shock
such as uncontrolled atrial fibrillation;
    (6) The applicant's left ventricular ejection fraction (EF) \1\ is
greater than 35% with a steady or improving trend;
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    \1\ The left ventricular ejection fraction measures the
percentage of blood that the left ventricle of the heart is able to
pump with each beat. A normal ejection fraction is greater than 50%.
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    (7) There is no history of any symptomatic or clinically
significant heart failure in the past two years;
    (8) There is no evidence of significant reversible ischemia on
myocardial perfusion imaging exercise stress testing;
    (9) The applicant's exercise capacity on formal stress testing
(using standard

Bruce Protocol) \2\ is greater than or equal to 8 metabolic equivalents
(METs); \3\
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    \2\ The Bruce protocol is a diagnostic test used in the
evaluation of cardiac function, developed by Robert A. Bruce. It is
a treadmill exercise test with set stages to ensure standardized
results. Each stage has a pre-set incline and speed. A stage is 3
minutes long.
    \3\ METs are a measure of physical work or exercise capacity.
While there is no direct correlation, generally the physical ability
guidelines in Enclosure (2) to NVIC 04-08 are similar to 6 METs. 8
METs are called for in the NVIC because the higher threshold results
in better diagnostic and prognostic information. A mariner facing an
emergency situation could likely be expected to have to function at
least at 8 METs.
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    (10) The applicant's treating cardiologist or electrophysiologist
provides a written assessment of the individual that supports a
determination that the mariner is at low risk for future arrhythmia,
adverse cardiac event or sudden incapacitation based upon objective
testing and standard evaluation tools; and
    (11) The applicant does not have any other medical conditions which
may alone, or in combination with an ICD or anti-tachycardia device,
pose an unacceptable risk for sudden incapacitation.

Discussion of Public Comments on ICD Policy

    On September 7, 2012 we published a notice in the Federal Register
requesting public comments on proposed ICD policy (77 FR 55174). We
received approximately 37 comments on whether to grant waivers for
anti-tachycardia devices or ICDs and the proposed criteria for such
waivers. The majority of the comments were supportive of the proposed
policy.
    Many commenters referenced specific individuals that they argued
were well qualified to hold a merchant mariner credential, despite
having an ICD. Although this notice was not designed to render fitness
determinations for specific individuals, the Coast Guard acknowledges
that there may be some mariners with ICDs who warrant consideration for
a medical waiver. The new policy clarification seeks to identify those
limited situations where a waiver will be considered.
    Several commenters felt that a requirement for applicants to reach
10 metabolic equivalents (METs) on a stress test using the standard
Bruce Protocol was excessive. Instead, these commenters favored a
standard of 8 METs, similar to the standard for other cardiac
conditions addressed in NVIC 04-08. The Coast Guard proposed use of the
10 METs standard because it provides additional prognostic information
over the 8 MET standard. Following review of the public comments,
however, the Coast Guard considered that, when combined with the
stringency of all of the criteria required by the policy, the 8 METs
standard provides sufficient prognostic information for evaluation. The
Coast Guard, therefore, agrees with these commenters, and Change-1
incorporates 8 METs as the relevant standard.
    Many commenters agreed with establishing waiver criteria, but they
suggested that some of the proposed criteria were too restrictive (3
year exclusionary period, 10 METs, EF >40%, etc.). Several commenters
expressed concern that the proposed checklist format was somewhat
rigid, and that it over-simplified the process to a ``go/no-go''
decision that would not allow all factors to be considered. In response
to these comments, we have determined that a relatively stringent set
of criteria with respect to anti-tachycardia devices and ICDs is
necessary because an underlying medical condition that warrants
treatment with an ICD generally poses an unacceptable risk for sudden
incapacitation. We developed the guidelines in Enclosure (7) to NVIC
04-08 for evaluating whether the underlying condition has improved
significantly, and to help determine whether it no longer poses an
inordinate risk. This allows for a margin of safety for individuals
with ICDs who are seeking to work in a safety-sensitive position. The
policy allows for an individual assessment, and, under exceptional
circumstances, applicants who do not meet all of the criteria may be
eligible for a waiver if they can demonstrate to the satisfaction of
the Coast Guard that there is not an inordinate risk. We will continue
to assess whether this policy strikes the proper balance between public
safety and an individual's interest in holding a merchant mariner
credential.
    Many commenters favored a case-by-case or individualized assessment
of the applicant's condition; as opposed to a blanket denial for all
applicants with ICDs. We note that even prior to Change-1, NVIC 04-08
has included a case-by-case evaluation of the applicant's condition. We
developed the criteria in Enclosure (7) to NVIC 04-08 in order to
provide a framework for those evaluations.
    Some commenters favored offering credential limitations, instead of
denial, if the condition still posed some risk. We note that applicants
who do not meet all of the outlined criteria in Enclosure (7) to NVIC
04-08 may be considered for a waiver if the Coast Guard is satisfied
that the risk can be reduced to an acceptable level. This may require
limiting the scope of the applicant's credential to enforce certain
working conditions that may reduce the risk of sudden incapacitation.
When circumstances warrant, the Coast Guard will work with individual
applicants to tailor restrictions and limitations appropriate to
individual situations.
    Many commenters felt that a cardiologist's assessment should be
sufficient for determining whether the applicant's medical condition is
safe enough to warrant granting a waiver. The Coast Guard disagrees.
The Coast Guard wishes to emphasize that mariner credentials often
enable individuals to work in safety-sensitive positions aboard
vessels, which amplifies the risks and potential consequences of a
condition requiring use of an ICD or anti-tachycardia device.
Accordingly, the Coast Guard has determined that a mariner's self-
evaluation, or even the evaluation of a physician, is not sufficient
evidence that the ICD, anti-tachycardia device, or underlying condition
pose no inordinate risk. While the Coast Guard gives the treating
physician's evaluation great weight, it is not the sole factor to
consider. Because the mariner's safety and public safety are at stake,
the Coast Guard has determined it must also consider the objective
criteria outlined in Enclosure 7 to NVIC 04-08 in making the final
decision of whether to grant a mariner's credential.
    Many commenters pointed out the risks to maritime safety posed by
prohibiting service as a mariner solely on the basis of the mode of
treatment (e.g., ICDs). These commenters felt that such a prohibition
would lead mariners to choose to forego medical treatment out of fear
of losing their jobs. This would pose a significant risk to both the
mariner and the public. Several commenters stated that a mariner with a
known, closely-managed medical condition and an ICD, is far safer for
the public and maritime industry than a mariner not seeking care, with
undiagnosed medical conditions. The Coast Guard shares these concerns,
and we crafted Enclosure (7) to NVIC 04-08 to focus more on the
underlying condition rather than the mere presence of an ICD.
    We received 6 comments from people who identified themselves as
physicians or representatives of a physician group. Two of these
commenters opposed allowing waivers for mariners with ICDs, arguing
that the ICD itself presents an inordinate risk, and that the
underlying condition would pose an inordinate risk. The Coast Guard
disagrees. While acknowledging that there may be some cases where the
ICD

and the underlying condition pose an inordinate risk of sudden
incapacitation, the Coast Guard has not found this to be true for all
individuals. For these reasons, the Coast Guard disagrees with imposing
a blanket exclusion of waivers for all individuals with ICDs. This
policy allows for an individualized assessment of the mariner. The
criteria outlined in Enclosure (7) to NVIC 04-08 are designed to
distinguish those individuals whose underlying conditions have
substantially improved and no longer pose an unacceptable risk of
sudden incapacitation. Individuals with ICDs who meet the stringent
criteria outlined in this policy, are at low enough risk to warrant
consideration for a medical waiver, and a blanket exclusion would
unnecessarily put mariners out of work.
    One of these commenters expressed the concern that an inappropriate
ICD discharge might result in sudden incapacitation. The Coast Guard
recognizes this concern, but found other comments to be more
persuasive. Specifically, cardiology experts commented on the low risk
of inappropriate ICD discharge in this carefully selected population,
and the ability to further mitigate such risk with selective device
programming. Furthermore, these experts pointed out that with modern
ICDs, the likelihood of an inappropriate ICD shock causing a sudden
incapacitation is extremely small, and the benefits of having an ICD
would outweigh any risk posed by the ICD in this setting.
    Three of the other four physicians/physician groups agreed with
establishing waiver criteria, but felt the proposed criteria were too
restrictive (3 year exclusionary period, EF of 40%, 10 METs). The Coast
Guard agrees in part. As noted above, we recognize that these criteria
are strict, but necessary to demonstrate that individuals are at low
enough risk to warrant consideration for a medical waiver. As discussed
above, mariner credentials often enable individuals to work in safety-
sensitive positions aboard vessels, which amplifies the risks and
potential consequences of a condition requiring use of an ICD or anti-
tachycardia device. Accordingly, the policy only grants waivers in
those instances where the mariner's underlying condition has improved
significantly such that it no longer poses an unacceptable risk of
sudden incapacitation. Because the mariner's safety and public safety
are at stake, the Coast Guard has chosen to maintain fairly stringent,
objective criteria (to include requiring three years of clinical
stability, recovery of the left ventricular ejection fraction and
normal exercise capacity) in making the final decision on whether to
grant a mariner's credential. As noted above, though, the Coast Guard
concedes that the ability to attain 8 METs of exercise capacity, and an
EF of 35%, along with meeting all of the other criteria outlined in the
policy, is sufficient to demonstrate low enough risk to warrant
consideration for a medical waiver. Additionally, under exceptional
circumstances, the policy allows for applicants who do not meet all of
the criteria to be considered for a waiver if the risk of sudden
incapacitation may be reduced.

Seizure Policy

    Generally, the final policy in Change-1 to NVIC 04-08 distinguishes
between provoked and unprovoked seizures. A summary of the waiver
criteria for both types of seizures is provided below.
    Unprovoked seizures are those seizures not precipitated by an
identifiable trigger. Mariners with a history of unprovoked seizure(s)
may be considered for a waiver as follows:
    (1) Mariners with a history of epilepsy or seizure disorder may be
considered for a waiver if the mariner has been seizure-free for a
minimum of eight years (on or off anti-epileptic drugs (AEDs)); and
    (a) If all AEDs have been stopped, the mariner must have been
seizure-free for a minimum of eight years since cessation of
medication; or
    (b) If still using AEDs, the mariner must have been on a stable
medication regimen for a minimum of two years.
    (2) Mariners with a single unprovoked seizure may be considered for
a waiver if the mariner has been seizure-free for a minimum of four
years, off AEDs; and
    (a) If all medication has been stopped, the mariner must have been
seizure-free for a minimum of four years since cessation of medication;
or
    (b) If still requiring treatment with AEDs, the mariner's condition
will be considered under the criteria for epilepsy listed above in (1)
(i.e., the mariner may be considered for a waiver after they have been
seizure-free for a minimum of 8 years, and on a stable medication
regimen for a minimum of two years).
    Provoked seizures are those seizures precipitated by an
identifiable trigger. (This does not include epileptic seizures or
seizures brought on by lack of sleep, stress, or photo-stimulation.
Seizures of this nature will be evaluated under the criteria for
unprovoked seizures listed above). Mariners with provoked seizures can
be divided into those with low risk of recurrence and those with a
higher risk of recurrence (e.g., with a structural brain lesion).
    (1) If a mariner is determined to be low-risk for seizure
recurrence, does not require AEDs, and the precipitating factor is
unlikely to recur, a waiver may be considered when the mariner has been
seizure-free and off medication for a minimum of one year.
    (2) Generally, mariners with one of the following precipitating
factors will be considered low-risk for recurrence:
    (a) Lidocaine-induced seizure during a dental appointment;
    (b) Concussive seizure, loss of consciousness <=30 minutes with no
penetrating injury;
    (c) Seizure due to syncope not likely to recur;
    (d) Seizure from an acute metabolic derangement not likely to
recur;
    (e) Severe dehydration;
    (f) Hyperthermia; or
    (g) Drug reaction or withdrawal.
    (3) If a mariner is determined to be at higher risk for seizure
recurrence, a waiver may be considered if the mariner has been seizure-
free for a minimum of eight years (on or off AEDs); and
    (a) If all medication has been stopped, the mariner must have been
seizure-free for a minimum of eight years since cessation of
medication; or
    (b) If still using AEDs, the mariner must have been on a stable
medication regimen for a minimum of two years.
    (4) Generally, mariners with a history of provoked seizures caused
by a structural brain lesion (e.g., tumor, trauma, or infection)
characterized by one of the following precipitating factors will be
considered at higher risk for recurrence:
    (a) Head injury with loss of consciousness or amnesia >=30 minutes
or penetrating head injury;
    (b) Intracerebral hemorrhage of any etiology, including stroke and
trauma;
    (c) Brain infection, such as encephalitis, meningitis, abscess, or
cysticercosis;
    (d) Stroke;
    (e) Intracranial hemorrhage;
    (f) Post-operative brain surgery with significant brain hemorrhage;
or
    (g) Brain tumor.
    (5) Under exceptional circumstances in which a mariner has had
provoked seizures due to a benign brain lesion that has subsequently
been removed, such individuals may be considered for a waiver once they
have been seizure-free for a minimum of four years, provided that
objective evidence supports extremely low risk of seizure recurrence.

Public Comments on Seizure Policy

    On March 25, 2013 we published a notice in the Federal Register

requesting public comments on proposed policy regarding waivers for
mariners with seizure disorders (78 FR 17917). We received 7 comments
on the proposed policy for granting waivers for mariners with seizure
disorders. The majority of commenters supported the proposed policy.
    One commenter agreed with the proposed policy, noting that the
criteria are strict, but appropriate when considered in light of the
risks associated with a mariner having a seizure while in a safety-
sensitive position aboard a ship.
    Another commenter questioned whether it was appropriate for the
Coast Guard to consider the guidelines and recommendations of the
Federal Motor Carrier Safety Administration (FMCSA) Medical Review
Board (MRB) and FMCSA's Medical Expert Panel regarding seizure
disorders in automobile drivers when developing similar Coast Guard
policy for mariners (see 78 FR 17918). The commenter suggested that
mariners may need to undergo stricter evaluations than automobile
drivers, such as evaluation by immersion in sea simulation and video
electronystagmography to study their vestibular systems. The Coast
Guard agrees that there may be special situations where certain
mariners may require more extensive evaluation. NVIC 04-08 reflects
that approach by giving the Coast Guard discretion to apply stricter
standards on a case-by-case basis as needed. The Coast Guard disagrees
that sea simulation and electronystagmography testing should be a
blanket requirement for all mariners with seizure disorders. Neither
the commenter nor the relevant medical literature provided acompelling
rationale to justify such comprehensive vestibular testing for every
mariner with a seizure disorder. Accordingly, the Coast Guard will
determine whether an individual mariner requires extensive vestibular
evaluation on a case-by-case basis, in consultation with the mariner's
treating neurologist.
    One commenter generally disagreed with the proposed policy, arguing
that it was too strict. This commenter felt that it should be
sufficient for mariners to demonstrate that their condition is under
control and they are under the care of a doctor. The Coast Guard
disagrees. As discussed above, mariner credentials often enable
individuals to work in safety-sensitive positions aboard vessels, which
amplifies the risks and potential consequences of a seizure disorder.
Accordingly, the Coast Guard has determined that a mariner's self-
evaluation, or even the evaluation of a physician, is not sufficient
evidence that a seizure disorder poses no inordinate risk. While the
Coast Guard gives the treating physician's evaluation great weight, it
is not the sole factor to consider. Because the mariner's safety and
public safety are at stake, the Coast Guard has determined it must also
consider the objective criteria described above in making the final
decision of whether to grant a mariner's credential.
    Notably, the Epilepsy Foundation provided comments in support of
the proposed policy. The Epilepsy Foundation identifies itself as the
leading voluntary health agency working on behalf of people with
epilepsy. The Epilepsy Foundation applauded the Coast Guard's efforts
to develop a policy that recognizes the potential for mariners with
seizure disorders to work, while allowing for a case-by-case evaluation
of the applicant's fitness. The Epilepsy Foundation also noted that
epilepsy is a highly variable disorder, with varying levels of seizure
control in different individuals. The Epilepsy Foundation pointed out
that this variability makes it difficult to generalize about safety
concerns and makes it inappropriate to enact blanket exclusionary rules
and qualification standards that bar individuals with epilepsy. The
Coast Guard agrees. Our policy has always included an individualized
evaluation of the mariner's condition to determine fitness. We
developed the criteria outlined in this policy to provide a framework
within which to make these evaluations and to provide a margin of
safety for individuals with seizure disorders who are seeking to work
in a safety-sensitive position.
    We also received 3 comments from individuals who self-identified as
physicians or representatives of physician groups. All agreed with the
decision to grant waivers for individuals with seizure disorders. One
physician argued that the criteria are too restrictive because the
required seizure-free time intervals are too long. The Coast Guard
agrees that the criteria are stringent, but believes they are necessary
to ensure the mariner's safety and public safety.
    One of the physicians contended that the criteria are not strict
enough. This physician expressed support for a 10-year seizure free
time period for seizures, similar to that recommended for commercial
drivers by the FMCSA's MRB. The Coast Guard disagrees. The aim of this
policy is to distinguish those individuals who are no longer at
inordinate risk of seizure recurrence. As part of the background
research for determining a reasonable seizure-free time interval, the
Coast Guard considered the recommendations of the FMCSA's MRB, which
uses a 10-year seizure-free requirement, as well as the recommendations
of the FMCSA's 2007 Neurology Medical Expert Panel (MEP). The 2007
Neurology MEP asserted that individuals with certain types of seizures
would be at low risk of seizure recurrence after 8 years or 4 years
seizure-free. The Coast Guard found the recommendations of the 2007
MEP, which were based upon contemporary medical literature and
research, to be more persuasive than the suggestion advocated by this
commenter or the position of the FMCSA MRB. The 4-year and 8-year
seizure-free time intervals allow sufficient time for individuals to
demonstrate clinical stability and to distinguish those who are at
lowest risk of seizure recurrence. Additionally, the Coast Guard notes
that the FMCSA has recently announced its decision to utilize the
recommendations of its 2007 MEP as the basis for evaluating commercial
drivers with epilepsy. Those recommendations are similar to the
criteria outlined in the Coast Guard's policy.
    The third physician group, the American Epilepsy Society (AES),
agreed with the policy as proposed. The AES acknowledged that the
criteria strict, but agreed that such criteria are necessary to address
public safety concerns. The Coast Guard agrees and will continue to
assess whether this policy strikes the proper balance between public
safety and an individual's interest in holding a merchant mariner
credential.
    The AES, the Epilepsy Foundation, and one self-identified physician
also provided responses to the seven questions that the Coast Guard
posed in the March 25, 2013 Federal Register notice as follows:
    (1) On the question of whether or not there is evidence that
chronic use of anti-epileptic drugs (AEDs) impairs judgment and
reaction time, both AES and the Epilepsy Foundation stated that AEDs
used in appropriate dosages do not affect these functions or result in
cumulative impairment. The other commenter noted that all AEDs have the
potential to impair judgment, mood and motor skills, but recommended
that this be considered on an individual basis, instead of drawing a
blanket conclusion. The Coast Guard agrees. The policy does not impose
a blanket disqualification for use of AEDs; instead it allows the Coast
Guard to consider the treating neurologist's assessment of medication
impairment when making a final determination.
    (2) All three of these commenters stated that there is no evidence
that

individuals who have been seizure-free and off AEDs for a period of
time have a lower likelihood of seizure recurrence than individuals who
have been apparently seizure-free and on stable AED dosing. The Coast
Guard agrees. The policy allows for those individuals with seizure
disorders who require treatment with AEDS to be considered for waivers,
similar to those who do not require treatment with AEDs.
    (3) On the question of risk of seizure recurrence as a function of
time since the last seizure among individuals on AEDs who are
apparently seizure-free, AES and the Epilepsy Foundation advised that
the risk of recurrent seizures decreases with time seizure-free, on or
off AED medications. The other commenter opined that the risk of
seizure recurrence in this setting was uncertain and dependent upon too
many variables. The Coast Guard agrees with both answers. Because the
risk of seizure recurrence decreases with time seizure-free, the policy
requires a minimum seizure-free time interval before an affected
individual can be considered for a waiver. Additionally, in
acknowledgement of the many variables that might affect likelihood of
seizure recurrence in a particular individual, the policy allows for an
individualized assessment and considers the risk evaluation of the
treating neurologist.
    (4) On the question of the likelihood of seizure recurrence as a
function of time in individuals who are seizure-free following removal
of a benign brain tumor, none of the commenters gave a specific answer.
AES and the Epilepsy Foundation advised, however, that such a situation
was already accounted for in the policy. The other commenter asserted
that the answer was too variable to generalize. The Coast Guard agrees.
The policy specifies a minimum seizure-free time interval for such
individuals, but also allows for an individualized assessment.
    (5)-(6) Questions five and six asked about the need and
appropriateness of applying operational limitations and/or restrictions
for mariners with seizure disorders. Both AES and the Epilepsy
Foundation pointed out that the seizure-free time requirements outlined
in the policy are conservative enough that if exceeded, there should be
no need to differentiate between roles. However, they did recommend
that less restrictive criteria be applied to individuals who do not
operate dangerous machinery, work over 10 feet above ground, pilot a
vessel, or stand watch alone. For these individuals, they recommended
consideration for specific jobs if they have been seizure free for one
year and on stable medications for one year. The other commenter
advised that use of operational restrictions and limitations may be
reasonable depending on the individual's job function and
circumstances. The Coast Guard agrees and will consider applying
operational limitations and/or restrictions on a case-by-case basis,
when appropriate.
    (7) Question seven asked if there are individuals with seizure
disorders due to a structural brain lesion that are at low-risk for
seizure recurrence. Both AES and the Epilepsy foundation noted that
individuals with structural brain lesions are at higher risk, as
reflected in the longer restriction times outlined in the policy. The
other commenter noted that the answer would depend on the definition of
structural brain lesion. The Coast Guard agrees. The policy outlines a
minimum seizure-free time interval for such cases, while allowing for
an individualized assessment and consideration of exceptional
circumstances.

III. Authority

    This notice is issued under the authority of 5 U.S.C. 552(a), 46
U.S.C 7101 et seq., 46 CFR 10.215, and Department of Homeland Security
Delegation No. 0710.1.

    Dated: August 28, 2013.
J.C. Burton,
Captain, U.S. Coast Guard, Director of Inspections & Compliance.
[FR Doc. 2013-23114 Filed 9-20-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 119 (Wednesday, June 22, 2022)]
[Notices]
[Pages 37361-37363]
[FR Doc No: 2022-13270]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95108; File No. SR-Phlx-2022-23]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options 7,
Section 4, Multiply Listed Options Fees

June 15, 2022.
    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 May 31, 2022, Nasdaq PHLX LLC (``Phlx'' 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Phlx's Pricing Schedule at Options
7, Section 4, ``Multiply Listed Options Fees (Includes options
overlying equities, ETFs, ETNs and indexes which are Multiply Listed)
(Excludes SPY).''
    While the changes proposed herein are effective upon filing, the
Exchange

has designated that the amendments be operative on June 1, 2022.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, 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
    Phlx proposes to amend its Pricing Schedule at Options 7, Section
4, ``Multiply Listed Options Fees (Includes options overlying equities,
ETFs, ETNs and indexes which are Multiply Listed) (Excludes SPY).''
Specifically, Phlx proposes to increase the maximum Qualified
Contingent Cross (``QCC'') rebate that will be paid by the Exchange in
a given month. The Exchange believes that increasing the maximum QCC
Rebate to be paid by the Exchange in a given month will incentivize
market participants to transact a greater amount of QCC Orders on Phlx.
    Today, the Exchange assesses a $.20 per contract QCC Transaction
Fee for a Lead Market Maker,\3\ Market Maker,\4\ Firm \5\ and Broker-
Dealer.\6\ Customers \7\ and Professionals \8\ are not assessed a QCC
Transaction Fee. QCC Transaction Fees apply to electronic QCC Orders
\9\ and Floor QCC Orders.\10\ Rebates are paid on all qualifying
executed electronic QCC Orders and Floor QCC Orders based on the
following six tier rebate schedule:\11\
---------------------------------------------------------------------------

    \3\ The term ``Lead Market Maker'' applies to transactions for
the account of a Lead Market Maker (as defined in Options 2, Section
12(a)). A Lead Market Maker is an Exchange member who is registered
as an options Lead Market Maker pursuant to Options 2, Section
12(a). An options Lead Market Maker includes a Remote Lead Market
Maker which is defined as an options Lead Market Maker in one or
more classes that does not have a physical presence on an Exchange
floor and is approved by the Exchange pursuant to Options 2, Section
11. See Options 7, Section 1(c). The term ``Floor Lead Market
Maker'' is a member who is registered as an options Lead Market
Maker pursuant to Options 2, Section 12(a) and has a physical
presence on the Exchange's trading floor. See Options 8, Section
2(a)(3).
    \4\ The term ``Market Maker'' is defined in Options 1, Section
1(b)(28) as a member of the Exchange who is registered as an options
Market Maker pursuant to Options 2, Section 12(a). A Market Maker
includes SQTs and RSQTs as well as Floor Market Makers. See Options
7, Section 1(c). The term ``Floor Market Maker'' is a Market Maker
who is neither an SQT or an RSQT. A Floor Market Maker may provide a
quote in open outcry. See Options 8, Section 2(a)(4).
    \5\ The term ``Firm'' applies to any transaction that is
identified by a member or member organization for clearing in the
Firm range at The Options Clearing Corporation. See Options 7,
Section 1(c).
    \6\ The term ``Broker-Dealer'' applies to any transaction which
is not subject to any of the other transaction fees applicable
within a particular category. See Options 7, Section 1(c).
    \7\ The term ``Customer'' applies to any transaction that is
identified by a member or member organization for clearing in the
Customer range at The Options Clearing Corporation (``OCC'') which
is not for the account of a broker or dealer or for the account of a
``Professional'' (as that term is defined in Options 1, Section
1(b)(45)). See Options 7, Section 1(c).
    \8\ The term ``Professional'' applies to transactions for the
accounts of Professionals, as defined in Options 1, Section 1(b)(45)
means any person or entity that (i) is not a broker or dealer in
securities, and (ii) places more than 390 orders in listed options
per day on average during a calendar month for its own beneficial
account(s). See Options 7, Section 1(c).
    \9\ Electronic QCC Orders are described in Options 3, Section
12.
    \10\ Floor QCC Orders are described in Options 8, Section 30(e).
    \11\ Volume resulting from all executed electronic QCC Orders
and Floor QCC Orders, including Customer-to-Customer, Customer-to-
Professional, and Professional-to-Professional transactions and
excluding dividend, merger, short stock interest or reversal or
conversion strategy executions, is aggregated in determining the
applicable volume tier.

------------------------------------------------------------------------
                                                                 Rebate
           Tier                         Threshold                 per
                                                                contract
------------------------------------------------------------------------
Tier 1....................  0 to 99,999 contracts in a month.      $0.00
Tier 2....................  100,000 to 299,999 contracts in a       0.05
                             month.
Tier 3....................  300,000 to 499,999 contracts in a       0.07
                             month.
Tier 4....................  500,000 to 699,999 contracts in a       0.08
                             month.
Tier 5....................  700,000 to 999,999 contracts in a       0.09
                             month.
Tier 6....................  Over 1,000,000 contracts in a           0.11
                             month.
------------------------------------------------------------------------

    The Exchange does not pay a QCC Rebate where the transaction is
either: (i) Customer-to-Customer; (ii) Customer-to-Professional; (iii)
Professional-to-Professional; or (iv) a dividend, merger, short stock
interest or reversal or conversion strategy execution (as defined in
Options 7, Section 4). The Exchange will continue to pay rebates on QCC
Orders as described above.
    Today, the maximum QCC Rebate to be paid in a given month may not
exceed $550,000. The Exchange proposes to increase the maximum QCC
Rebate that will be paid in a given month from $550,000 per month to
$750,000 per month. The continued elevated options volume is the
primary reason for this amendment.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\12\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\13\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \14\
---------------------------------------------------------------------------

    \14\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Likewise, in NetCoalition v. Securities and Exchange Commission
\15\ (``NetCoalition'') the D.C. Circuit upheld the Commission's use of
a market-based approach in evaluating the fairness of market data fees
against a challenge claiming that Congress mandated a cost-based
approach.\16\ As the court emphasized, the Commission ``intended in
Regulation NMS that `market forces, rather than regulatory
requirements' play a role in determining the market data . . . to be
made available to investors and at what cost.'' \17\
---------------------------------------------------------------------------

    \15\ NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).
    \16\ See NetCoalition, at 534-535.
    \17\ Id. at 537.
---------------------------------------------------------------------------

    Further, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of

where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'. . . .'' \18\ Although the court and
the SEC were discussing the cash equities markets, the Exchange
believes that these views apply with equal force to the options
markets.
---------------------------------------------------------------------------

    \18\ Id. at 539 (quoting Securities Exchange Act Release No.
59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008)
(SR-NYSEArca-2006-21)).
---------------------------------------------------------------------------

    The Exchange believes that it is reasonable to increase the maximum
QCC Rebate the Exchange would pay a market participant in a given month
from $550,000 to $750,000 because it will incentivize market
participants to transact a greater amount of QCC Orders on Phlx in
order to obtain the maximum QCC Rebate offered by the Exchange.
Additionally, the Exchange believes the elevated maximum QCC Rebate is
in line with increased options volumes.
    The Exchange believes that it is equitable and not unfairly
discriminatory to increase the maximum QCC Rebate the Exchange would
pay a market participant in a given month from $550,000 to $750,000
because all qualifying market participants are eligible to transact QCC
Orders, either electronically or on the Trading Floor, and would,
therefore, be eligible to receive up to the maximum amount of QCC
Rebate, provided they transacted the qualifying number of QCC Orders.

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.
Inter-Market Competition
    The proposal does not impose an undue burden on inter-market
competition. The Exchange believes its proposal remains competitive
with other options markets and will offer market participants with
another choice of where to transact options. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited.
Intra-Market Competition
    The proposed amendments do not impose an undue burden on intra-
market competition. The Exchange believes that increasing the maximum
QCC Rebate the Exchange would pay a market participant in a given month
from $550,000 to $750,000 does not impose an undue burden on
competition because all qualifying market participants are eligible to
transact QCC Orders, either electronically or on the Trading Floor, and
would, therefore, be eligible to receive up to the maximum amount of
QCC Rebate, provided they transacted the qualifying number of QCC
Orders.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\19\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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: (i)
necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) 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-Phlx-2022-23 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-Phlx-2022-23. 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 website (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 website 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-Phlx-2022-23 and should be submitted on
or before July 13, 2022.
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-13270 Filed 6-21-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Page 65693]
[FR Doc No: 2012-26635]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Cellular, Tissue and Gene Therapies Advisory Committee; Amendment
of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment
to the notice of a meeting of the Cellular, Tissue and Gene Therapies
Advisory Committee. This meeting was announced in the Federal Register
of October 17, 2012 (77 FR 63840-63841). The amendment is being made to
reflect a change in the Date and Time, Agenda, Procedure, and Closed
Committee Deliberations portions of the document. There are no other
changes.

FOR FURTHER INFORMATION CONTACT:  Gail Dapolito or Sheryl Clark, Center
for Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852,<PHONE_NUMBER>,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington DC area). Please call the Information Line for
up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:  In the Federal Register of October 17,
2012, FDA announced that a meeting of the Cellular, Tissue and Gene
Therapies Advisory Committee would be held on November 29, 2012. On
page 63841, in the first column, the Date and Time portion of the
document is changed to read as follows:
    The teleconference meeting will be held on November 29, 2012 from 1
p.m. to 4:30 p.m., Eastern Time.
    On page 63841, in the first column, last paragraph, the Agenda
portion is changed to read as follows:
    On November 29, 2012 the committee will meet in open session to
hear updates of research programs in the Gene Transfer and
Immunogenicity Branch, Office of Cellular, Tissue and Gene Therapies,
Center for Biologics Evaluation and Research, FDA.
    On page 63841, second column, second paragraph, first sentence, the
Procedure portion is changed to read as follows:
    On November 29, 2012, from 1 p.m. to 2:30 p.m. (Eastern Time) the
meeting is open to the public.
    On page 63841, second column, second paragraph, fourth sentence,
the Procedure portion is changed to read as follows:
    Oral presentations from the public will be scheduled between
approximately 2:30 p.m. and 3:30 p.m.
    On page 63841, second column, third paragraph, first sentence, the
Closed Committee Deliberations portion is changed to read as follows:
    On November 29, 2012 from approximately 3:30 p.m. to 4:30 p.m., the
meeting will be closed to permit discussion where disclosure would
constitute a clearly unwarranted invasion of personal privacy (5 U.S.C.
552b(c)(6)).
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: October 23, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-26635 Filed 10-29-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: June 19, 2008 (Volume 73, Number 119)]
[Rules and Regulations]
[Page 34864-34865]
[DOCID:fr19jn08-12]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2008-0486]

Drawbridge Operation Regulations; Long Island, New York Inland
Waterway From East Rockaway Inlet to Shinnecock Canal, Hempstead, NY,
Public Event

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Meadowbrook State Parkway Bridge across Sloop Channel at mile 12.8, at
Hempstead, New York. Under this temporary deviation the bridge may
remain in the closed position for 2\1/2\ hours to facilitate public
safety during a public event, the Veterans Fireworks Display.

DATES: This deviation is effective from 9:30 p.m. through 11:59 p.m. on
June 28, 2008 and in the case of rain, from 9:30 p.m. to 11:59 p.m. on
June 29, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0486 and are available online
at http://www.regulations.gov. They are also available for inspection
or copying at two locations: the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays, and
the First Coast Guard District, Bridge Branch Office, 408 Atlantic
Avenue, Boston, Massachusetts 02110, between 7 a.m. and 3 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Judy Leung-Yee, Project Officer, First
Coast Guard District, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Meadowbrook State Parkway Bridge has a
vertical clearance in the closed position of 22 feet at mean high water
and 25 feet at mean low water. The existing drawbridge operation
regulations are listed at 33 CFR Sec.  117.799(h)(2).
    The waterway has seasonal recreational vessels and fishing vessels
of various sizes.

    The Town of Hempstead, Department of Public Safety, requested a
temporary deviation to facilitate a public event, the Veteran's
Fireworks Display on June 28, 2008.
    Under this temporary deviation, in effect between 9:30 p.m. and
11:59 p.m. on June 28, 2008, the Meadowbrook State Parkway Bridge at
mile 12.8, across Sloop Channel, may remain in the closed position.
Vessels that can pass under the bridge without a bridge opening may do
so at all times.
    In the event of inclement weather on June 28, 2008, the deviation
will be in effect on June 29, 2008, from 9:30 p.m. to 11:59 p.m., as a
rain date.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: June 11, 2008.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. E8-13863 Filed 6-18-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)]
[Notices]
[Pages 13458-13459]
[FR Doc No: 2017-04839]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1112]

United States Food and Drug Administration and Health Canada
Joint Regional Consultation on International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use; Public
Meeting and Webcast; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a regional public meeting entitled ``U.S. Food and Drug
Administration and Health Canada Joint Regional Consultation on
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH).'' The goal of this meeting is to
provide information and receive comments on the current activities of
ICH, as well as the upcoming ICH meetings in Montreal. The topics to be
covered in the public meeting are the topics for discussion at the
forthcoming ICH Assembly Meeting in Montreal. The purpose of this
public meeting is also to solicit public input prior to the ICH
Assembly meeting and the Expert Working Group meetings in Montreal,
Canada, scheduled for May 28 through June 1, 2017.

DATES: The public meeting will be held on April 24, 2017, from 11 a.m.
to 2 p.m., Eastern Time. Submit either electronic or written comments
on this public meeting by May 12, 2017. Late, untimely filed comments
will not be considered. Electronic comments must be submitted on or
before May 12, 2017. The https://www.regulations.gov electronic filing
system will accept comments until midnight Eastern Time at the end of
May 12, 2017. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date. See the SUPPLEMENTARY INFORMATION section for registration
date and information. Registration to attend the meeting and requests
for oral presentations must be received by April 19, 2017; see the
SUPPLEMENTARY INFORMATION section for information on how to register
for the meeting.

ADDRESSES: The public meeting will be held at 10903 New Hampshire Ave.,
Bldg. 31, Rm. 1503 Section A, Silver Spring, MD 20993. It will also be
broadcast on the Web allowing participants to join in person OR via the
Web. Entrance for the public meeting participants (non-FDA employees)
is through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-1112 for the U.S. Food and Drug Administration and Health
Canada Joint Public Consultation on International Council on
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting. Received comments, those filed in a timely manner
(see DATES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amanda Roache, Food and Drug
Administration, Center for Drug Evaluation and Research, Office of
Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176,
Silver Spring MD, 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The ICH, formerly known as the International Conference on
Harmonisation, was established in 1990 as a joint regulatory/industry
project to improve, through harmonization, the efficiency of the
process for developing and registering new medicinal products in
Europe, Japan, and the United States without compromising the
regulatory obligations of safety and effectiveness. In 2015 the ICH was
reformed to make the ICH a true global initiative that expands beyond
the previous ICH members. More involvement from regulators around the
world is expected, as they will join their counterparts from Europe,
Japan, USA, Canada, and Switzerland as ICH regulatory members. The
reforms build on a 25-year track record of successful delivery of
harmonized guidelines for global pharmaceutical development, and their
regulation. In recent years, many important initiatives have been
undertaken by regulatory authorities and industry associations to
promote international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for medical product development among regulatory Agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. The ICH process has achieved significant
harmonization of the technical requirements for the approval of
pharmaceuticals for human use in the ICH regions over the past two
decades. The current ICH process and structure can be found at the
following Web site: http://www.ich.org. (FDA has verified the Web site
addresses as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.)

II. Webinar Attendance and Participation

A. Registration

    If you wish to attend the meeting, please register at the following
Web site: https://ich_regional_consultation.eventbrite.com.
Registrations may be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, the number of participants from each organization may be
limited based on space limitations. Registrants will receive
confirmation once they have been accepted. If you need special
accommodations because of a disability, please contact Amanda Roache
(see FOR FURTHER INFORMATION CONTACT) at least 7 days before the
meeting.

B. Requests for Oral Presentations

    Interested persons may present data, information, or views orally
or in writing on issues pending at the public meeting. Public oral
presentations will be scheduled between approximately 1:30 p.m. and 2
p.m. Time allotted for oral presentations may be limited to 5 minutes.
Those desiring to make oral presentations should notify Amanda Roache
(see FOR FURTHER INFORMATION CONTACT) by April 19, 2017, and submit a
brief statement of the general nature of the evidence or arguments they
wish to present; the names and addresses, telephone number, fax, and
email of proposed participants; and an indication of the approximate
time requested to make their presentation. The agenda for the public
Webinar will be made available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm536015.htm.

    Dated: March 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04839 Filed 3-10-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 46 (Friday, March 8, 2013)]
[Rules and Regulations]
[Pages 14913-14914]
[FR Doc No: 2013-05475]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

14 CFR Part 254

RIN 2105-AE21
[Docket DOT-OST-2013-0044]

Domestic Baggage Liability

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Final rule.

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SUMMARY: In accordance with existing regulations, this final rule
raises the minimum limit on domestic baggage liability applicable to
air carriers to reflect inflation since July 2008, the basis month of
the most recent previous revision to the liability limit. DOT
regulations require that the Department of Transportation periodically
revise the limit to reflect changes in the Consumer Price Index for All
Urban Consumers (CPI-U). This revision adjusts the minimum limit of
liability from the current amount of $3,300, set by the Department in
November 2008, to $3,400, to take into account the changes in consumer
prices since the prior revision.

DATES: This rule is effective on June 6, 2013.

FOR FURTHER INFORMATION CONTACT: Nicholas Lowry, Senior Attorney,
Office of the General Counsel, Department of Transportation, 1200 New
Jersey Ave. SE., Washington, DC 20590;<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Revision of Liability Limit

    Part 254 of the Department's rules (14 CFR part 254) establishes
minimum baggage liability limits applicable to domestic air service.
Section 254.6 of this rule requires the Department to review every 2
years the minimum limit of liability prescribed in Part 254 in light of
changes in the CPI-U and to revise the limit of liability to reflect
changes in that index as of July of each review year. Section 254.6
prescribes the use of a specific formula to calculate the revised
minimum liability amount when making these periodic adjustments. The
formula is below.

$2500 x (a/b) rounded to the nearest $100

Where:

a = July CPI-U of year of current adjustment
b = the CPI-U figure in December 1999 when the inflation adjustment
provision was added to part 254.

The review in 2010 indicated that no inflation adjustment was required.
In 2012, the review indicated that an inflation adjustment is required.
Applying the formula to price index changes occurring between December
1999 (the basis month required by the formula) and July 2012 (the month
for each biannual adjustment as specified in the formula), the
appropriate inflation adjustment is $2,500 x 228.723/168.8 [$2,500 x
1.355], which yields $3,387.50. (The base amount of $2,500 in the
formula was the minimum liability limit in Part 254 at the time that
this biennial indexing provision was added to the rule, 228.723 was the
CPI-U for July 2012, and 168.8 was the CPI-U for December 1999. The
CPI-U data are from the seasonally adjusted series.) Section 254.6
requires us to round the adjustment to the nearest $100, or to $3,400
in this case.

    In its rule ``Enhancing Airline Passenger Protections'' (76 FR
23110, Apr. 25, 2011), the Department required the amount of
compensation due to passengers in instances of denied boarding (DBC) to
be adjusted to reflect CPI-U changes. Under 14 CFR 250.5(e), the review
of denied boarding compensation was to take place every 2 years, with
the first such review occurring in July 2012, to coincide with our
review of the baggage liability amount. We have reviewed the
compensation amounts stated in the 2011 rule according to the formula
set out in section 250.5(e) and found that no change in DBC amounts is
warranted in 2012.

II. Regulatory Analyses and Notices

    The Administrative Procedure Act (APA) (5 U.S.C. 553) contains a
``good cause'' exemption which allows agencies to dispense with notice
and comment if those procedures are impracticable, unnecessary or
contrary to the public interest. We have determined that under 5 U.S.C.
553(b)(3)(B) good cause exists for dispensing with a notice of proposed
rulemaking and public comment as the application of this rule does not
involve any agency discretion. This rulemaking is required by the terms
of 14 CFR

254.6, as most recently amended in (73 FR 70591, November 21, 2008) and
is simply a ministerial inflation update based on a formula.
Accordingly, we find that prior notice and comment are unnecessary, and
we are issuing these revisions to Part 254 as a final rule.
    Although this final rule will become effective on June 6, 2013, in
order to avoid imposing an undue burden the Department will defer
enforcement of the notice provision in the rule (section 254.5) as it
pertains to printed notices about the new limit for a reasonable time
period to allow carriers to replace or update any current paper ticket
stock and ticket jackets or inserts. Electronic notices about the
minimum domestic liability limit, including notices that are printed
``on demand'' from an electronic source (e.g., Web sites, email
messages, and airport kiosks) should be updated no later than the
effective date of this final rule. Carriers are subject to enforcement
action from the effective date of this final rule if they fail to
provide notice of the new minimum liability limit in the manner
described above, or if they fail to apply the new limit.

Executive Order 12866

    This final rule has been evaluated in accordance with existing
policies and procedures and is considered not significant under both
Executive Order 12866 and DOT's Regulatory Policies and Procedures. The
rule has not been reviewed by the Office of Management and Budget (OMB)
under Executive Order 12866. This revision of 14 CFR 254.4 provides for
an inflation adjustment to the amount of the minimum limit on baggage
liability that air carriers may incur in cases of mishandled baggage,
as required by section 254.6. The provisions are required by current
regulatory language, without interpretation.
    This rule will pose minor additional costs to airlines only in
those instances in which carriers lose, damage or delay baggage and
where the amount of the passenger's claim in those instances exceeds
the prior minimum liability limit of $3,300. The maximum potential
impact in those instances is $100 on each such claim. Reports filed
each month with the Department by airlines that each account for at
least one percent of total domestic scheduled-service passenger
revenues show that, in 2012, approximately 0.3 percent (.003) of
domestic passengers experience a mishandled bag. The total number of
domestic scheduled passenger enplanements in 2012 was 652,178,681. This
means that approximately 2 million domestic scheduled passengers
experience a mishandled bag each year (.003 multiplied by 652.2 equals
1,956,536). However, the vast majority of the instances of mishandled
baggage do not result in a claim in an amount that is affected by the
liability limit in this rule. We contacted a few carriers to determine
how many of their domestic passengers have had claims that exceed the
prior minimum liability limit of $3,300. Based on the information
provided, we believe a little more than one half percent (0.0058) of
the domestic passengers who experience a mishandled bag would benefit
from an increase in the minimum limit on baggage liability, i.e., about
11,300 passengers. Therefore, we expect that there would be a cost to
the airline industry of $1.1 million each year (the number of domestic
passengers who receive a baggage settlement that exceeds the prior
minimum liability limit of $3,300, which is 11,300 passengers
multiplied by the maximum potential impact in those instances which is
$100). There would also be a benefit to passengers in the same amount.

Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) requires
an assessment of the impact of proposed and final rules on small
entities unless the agency certifies that the proposed regulation will
not have a significant economic impact on a substantial number of small
entities. Since notice and comment rulemaking is not necessary for this
rule, the provisions of the Regulatory Flexibility Act (Pub. L. 96-354,
5 U.S.C. 601-612) do not apply. However, DOT has evaluated the effects
of this action on small entities and has determined that the action
would not have a significant economic impact on a substantial number of
small entities. An air carrier is a small business if it provides air
transportation only with small aircraft (i.e., aircraft with up to 60
seats/18,000 pound payload capacity). See 14 CFR 399.73. This revision
affects only flight segments operated with large aircraft and other
flight segments appearing on the same ticket as a large-aircraft
segment. As a result, many operations of small entities, such as air
taxis and many commuter air carriers, are not covered by the rule.
Moreover, any additional costs for small entities associated with the
rule should be minimal and may be covered by insurance. Accordingly, we
certify that this action will not have a significant economic impact on
a substantial number of small entities.

Paperwork Reduction Act

    This final rule imposes no new reporting or record keeping
requirements necessitating clearance by OMB.

List of Subjects in 14 CFR Part 254

    Air carriers, Administrative practice and procedure, Consumer
protection, Department of Transportation.

    Accordingly, the Department of Transportation amends 14 CFR part
254 as follows:

PART 254--DOMESTIC BAGGAGE LIABILITY

0
1. The authority citation for part 254 continues to read as follows:

    Authority: 49 U.S.C. 40113, 41501, 41504, 41510, 41702 and
41707.

Sec.  254.4  [Amended]

0
2. Section 254.4 is amended by removing ``$3,300,'' and adding
``$3,400'' in its place.

Sec.  254.5  [Amended]

0
3. In Sec.  254.5, paragraph (b) is amended by removing ``$3,300'' and
adding ``$3,400'' in its place.

    Issued in Washington, DC, on March 4, 2013, pursuant to
authority delegated in 49 CFR 1.27(n).
Robert S. Rivkin,
General Counsel.
[FR Doc. 2013-05475 Filed 3-7-13; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: March 17, 2009 (Volume 74, Number 50)]
[Notices]
[Page 11386-11387]
[DOCID:fr17mr09-68]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59547; File No. SR-NASDAQ-2009-014]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Establish New Rules Applicable to the Nasdaq Market Center and Nasdaq
Options Market That Explicitly Require Members To Input Accurate
Information Into Nasdaq Systems

March 10, 2009.
    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 February 23, 2009, The NASDAQ Stock Market LLC (``Nasdaq'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by Nasdaq. Nasdaq filed the proposed rule change as
a ``non-controversial'' proposed rule change pursuant to Section
19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which
renders the proposal effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to establish new rules applicable to the Nasdaq
Market Center and Nasdaq Options Market that explicitly require members
to input accurate information into Nasdaq systems. The text of the
proposed rule change is available from Nasdaq's Web site at http://
nasdaq.cchwallstreet.com, at Nasdaq's principal office, 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, Nasdaq included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item III below, and is set forth in Sections A, B, and C below.

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

1. Purpose
    Nasdaq proposes to adopt new rules that make clear Nasdaq members'
responsibility to input accurate quotation and order information into
the Nasdaq Market Center and Nasdaq Options Market (collectively the
``Nasdaq Markets''). The Nasdaq Markets require entry of certain
information to post a quote or to enter an order. Such information,
among other things, identifies the member, the size and price of the
order or quote, and the member's capacity in placing an order. Accurate
trade and quote information is fundamental to the operation of an
efficient and fair market. Moreover, the information input by members
when posting a quote or placing an order is used for purposes of
policing the Nasdaq Markets. For example, the Financial Industry
Regulatory Authority, Inc. (``FINRA'') conducts trade abuse
surveillances of the Nasdaq Markets on Nasdaq's behalf. The trade abuse
surveillances use capacity information input by members. A member's
capacity in a trade concerns whether the member is acting as an agent,
principal, or ``riskless'' principal in the transaction. Accordingly,
accurate input of capacity information is of fundamental regulatory
importance.
    Nasdaq does not have a rule that makes an explicit statement
regarding a member's obligation to input accurate information into the
Nasdaq Markets. Notwithstanding, Nasdaq believes that disciplinary
cases against members entering inaccurate or incomplete information may
be brought appropriately under Nasdaq Rule 2110, which requires members
to observe high standards of commercial honor and just and equitable
principles of trade. Rule 2110 protects the investing public and the
securities industry from dishonest

practices that are unfair to investors or hinder the functioning of a
free and open market, even though those practices may not be illegal or
violate a specific rule or regulation. Because of the regulatory
importance of accurate information input into the Nasdaq Markets,
Nasdaq believes rules that directly address members' obligation to
provide accurate information are warranted. The proposed rules make
clear members' obligation to input accurate information into the Nasdaq
Markets, and that failure to do so would be considered a violation of
Nasdaq rules.
    Nasdaq notes that FINRA has rules that require the accurate entry
of certain trade information into its systems. For example, FINRA Rule
7330(d) requires FINRA members to report to the OTC Reporting Facility
certain specific trade-related information. A failure to provide such
information represents a violation of FINRA Rules, and may result in
disciplinary action. FINRA has substantially similar requirements for
other trade reporting systems it operates.\5\
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    \5\ See FINRA Rules 7230A and 7230B.
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2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\6\ in general, and with Section
6(b)(5) of the Act,\7\ in particular, in that the proposal is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, 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. The amendments proposed
herein will serve to promote the accuracy of information input into the
Nasdaq Markets. Accurate information is necessary for the efficient and
fair operation of the Nasdaq Markets, and will assist Nasdaq in
surveilling the markets for fraudulent activity.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    This the foregoing proposed rule change does not: (i) significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, it has become effective pursuant to
Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). The Exchange also provided the
Commission with written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
the proposed rule change as required by Rule 19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2009-014 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2009-014. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Nasdaq. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2009-014 and should
be submitted on or before April 7, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-5714 Filed 3-16-09; 8:45 am]

BILLING CODE 8011-01-P