DISCUSSION QUESTIONS FOR MOSQUITO REPELLENT STUDIES

The Human Studies Review Board (HSRB or Board) has discussed and
provided advice to EPA on scientific and ethical issues related to the
conduct of field studies to evaluate the efficacy of mosquito repellent
products.  The HSRB has reviewed both proposals for new field studies
and the results of completed studies.  The HSRB has noted that, although
there are many similarities across studies, not all studies employ the
same study design.  The HSRB has identified several methodological
issues for which additional background information would assist the
Board in its evaluation of such studies.

BACKGROUND

Currently, EPA requires all pesticide products that claim to repel
mosquitoes to provide data on the duration of efficacy under field
conditions at two biologically distinct sites.  These data are derived
from human research with subjects who have been treated with the
repellent formulations in the field.  The Agency evaluates the duration
of repellent efficacy for a subject by calculating the time from
application of the repellent to the occurrence of an event indicating an
efficacy failure.  Historically, for field studies of mosquito
repellency, EPA has used the “first confirmed bite” as an indication
of efficacy failure on a test subject.  Several recent studies have
shifted to the “first confirmed landing with intent to bite;” EPA
has accepted this alternative endpoint.  A “confirmed landing” on a
test subject is a mosquito landing followed by a second landing on the
same subject within a specified period of time (usually 30 minutes)
after the initial landing.

Field studies typically involve 6 – 10 subjects who have been treated
with a defined amount of the test material.  Each subject is then
regularly and repeatedly exposed to ambient mosquito populations for a
fixed interval of time until the subject experiences an efficacy failure
followed by a confirmation with the specified period of time. Mosquito
landing pressure (representing intent to bite) at a site is monitored by
concurrently exposing untreated subjects to mosquito landings.  A study
is considered valid only if there are at least a specified minimum
number of mosquito landings on untreated subjects during each exposure
interval.

On October 25, 2007, the HSRB will discuss scientific aspects of the
design of field studies to assess the efficacy of mosquito repellents.
For this meeting the Board has requested consultants to provide
specialized information or assistance to the Board.   The Board is
particularly interested in the frequency, duration and timing of
exposure of subjects to potential mosquito landings.  The Board requests
each consultant to respond briefly to the series of questions below.
Please send the responses to the HSRB Chair and Designated Federal
Official (DFO) at least one week before the meeting—i.e., by no later
than October 18.  All responses will subsequently be provided to the
other consultants, the HSRB members, and EPA staff for their review, and
will be posted on   HYPERLINK "http://www.regulations.gov"
www.regulations.gov  under docket ID number, EPA-HQ-ORD-2007-0942.  HSRB
consultants will be available at the meeting to discuss their responses
and address questions from the Board.  The questions for Board
consultant consideration are provided below:

DISCUSSION QUESTIONS

	What do data show about the variability of the time intervals
between first and subsequent landings in mosquito repellent field
trials?

The time between first and second (or subsequent) landings is likely to
be very variable. Thirty minutes is usually suggested as a long enough
interval to allow for any mosquitoes in the area to land.

	What is the current scientific understanding of how factors other
than repellent efficacy could affect the likelihood that an initial
event—a mosquito landing or mosquito bite—would be “confirmed”
by another similar event within 30 minutes?  Please address at least
these factors:

o	Characteristics of mosquito populations

The assumption is that the susceptibility of the mosquito population
follows a normal distribution, and therefore the first mosquito to land
is likely to be at the edge of that distribution. Statistically, the
variation and abundance of the population will dictate when the second
landing occurs. Presumably, the interval between landings will decrease
as the middle of the distribution curve is reached.

The literature documents that particular species of mosquitoes are
characteristically more or less susceptible to a given active
ingredient. Therefore, the interval between first and second landing
will depend on the species. This assumes a normal curve response to
repellency, as is observed in the laboratory in dose-response studies.

It is also documented that size of individual mosquitoes affects
avidity, generally with larger mosquitoes being more avid. Therefore, a
population that had good larval nutrition (and more uniform, larger
adults) is probably more likely to have a shorter interval between first
and second landings.

Age of mosquitoes affects avidity, with at least some studies showing
that older mosquitoes can be more avid. If the population is from a
single brood, and therefore of similar age, then two effects will occur
with age. First, the older mosquitoes may be more avid and, second, the
population will decline in numbers as it ages.

Most species of mosquitoes do not bite when they are gravid or within
the first approximately 12-24 hours after oviposition. Especially if the
current population of adults developed from a single hatching event
(e.g., a rising river hatching a brood of floodwater mosquitoes), there
might be an interval when many are gravid or recently parous and the
effective biting population is low. The low population would cause a
longer interval between first and second landing.

o	Characteristics of test sites

Some conditions are known to discourage mosquito biting and host
seeking. Low temperatures, higher winds, and small phases of the moon
are examples. Presumably, these conditions would lengthen the interval
between first and second landings by influencing the avidity of the
population as a whole.

o	Characteristics of test subjects

People can be more attractive  to mosquitoes because of inherent
characteristics (skin color, skin chemistry, blood chemistry) or
characteristics associated with activity or temporary conditions
(apocrine sweat, skin temperature, illness, alcohol consumption). People
who are more attractive to biting mosquitoes would experience a shorter
interval between first and second landings if we accept the assumption
that the normal curve describing attraction to that particular host is
narrower.

o	Characteristics of test methods

If more of the person were exposed (e.g., only forearms compared to arms
and legs), then mosquitoes should find the host more quickly  and the
interval between first and second landings would be shorter. This is a
testable hypothesis and I am not sure it has been addressed in the
literature.

If the person is instructed to walk around between tests, or if s/he
moves around even while seated, mosquitoes in the vicinity  will have
stronger visual cues for orientation and the interval between first and
second landings could be shorter. This will be particularly true for
mosquitoes that tend to bite larger animals, like floodwater Aedes,
Anopheles, and some container breeders.

Although we think of most repellents as having very little effect over a
distance, almost all of them actually perform in the olfactory phase.
Therefore, a volatile repellent (e.g., deet or oil of citronella) will
have a greater spatial effect if more volume is used on the individual.
A larger volume of a volatile repellent (i.e., if a larger part of the
body was treated) might make the degradation curve of effectiveness more
shallow and therefore lengthen the time between first and second
landings.

When the concentration of less volatile repellents (e.g., Picaridin,
PMD) decreases, landing can occur without biting. In this case, the same
individual mosquito might land, not bite, then land again. That
situation would result in a very short interval between first and second
landings.

	Can the impact of such factors on the likelihood or timing of an
initial and confirming event be predicted?  Can it be quantified?

No.

At its June 27 - 29, 2007 meeting the Board learned that different
designs with different “length-biased” sampling for mosquito
repellent field studies are in use.  One design exposes subjects to
potential mosquito landings for one minute of every 15 minutes; another
design exposes subjects to potential mosquito landings for five minutes
of every 30 minutes.  The
DFO椠⁳敳慰慲整祬瀠潲楶楤杮愠䌠⁄潣瑮楡楮杮琠敨戠
捡杫潲湵慭整楲污⁳潦⁲桴畊敮㈠‷ₖ㤲〲㜰䠠
剓⁂敭瑥湩⹧†桔牰瑯捯汯⁳牡潬摡摥漠桴䑃
吠敨敳搠獥杩獮栠癡楤晦牥湥⁴沓湥瑧⵨楢獡摥ₔ
慳灭楬杮ഠ

	What is the methodological rationale for the two different designs?

There is nothing very standard about these timing regimes.

	Which design is used more widely in the field? Why?

The 30 minute design (or a one hour design) is much more common in the
literature. One reason is that it is easier to perform. The other reason
is that the perceived precision seems to be adequate given the inherent
imprecision of the measurement. In other words, you are never going to
get consistent protection times on a scale finer than about 30 minutes
and even if you did, would it be meaningful in terms of real world
variability in performance?.

	Can potential effects of variation in the pattern of intermittent
exposure on the results of efficacy testing be isolated from the effects
of other variables?  If so, can the direction or magnitude of the
effects be predicted?  How might these influences be analyzed and
accounted for in collecting, reporting and analyzing repellent efficacy
data?

It might be possible to adjust for wind and temperature, if the studies
have been done for that particular area and those species of mosquitoes.
That way, you would adjust the result for the conditions measured at the
time of the intermittent exposure. A much more serious problem is that
the biting activity of mosquitoes varies systematically with time of
day. It is never really accurate to do a repellent trial continuously
for more than about an hour or two because the avidity of the mosquito
population will start to change significantly. The best designs treat
people the appropriate number of hours before the peak biting time and
the expose all subjects simultaneously.

Dr. Matt Kramer, a USDA statistician who has served as a consultant, has
suggested that the precision of estimates of Complete Protection Time
(CPT) in repellent testing could be significantly increased by defining
a failure of efficacy as the mean time from treatment to a series of
several landings or bites.  He has stated:

The precision of CPT increases when it is estimated beyond time to
[First Confirmed Bite] FCB or FCLanding.  How well CPT can be estimated
depends on the distribution of so many bites beyond FCB.  The number of
mosquitoes that will bite (n) will determine results of the test.  Each
person in the field should be his/her own control; that way it is
possible to know n per person, and reduce person-to-person variability.

If using the mean time to the first 5 bites, the SE will decrease
proportionally as n increases (n = 5 in this case).  That is equivalent
to an increase in the power of the test of 5 times.  This method allows
for detecting formulation differences near the CPT.

	Does this approach, indeed, increase the precision of estimates of
CPT markedly without requiring additional subjects?

Yes. In an extreme case, it might even decrease exposure by requiring
less replication.

A statistician needs to look at the problem, but I would advocate that
the mean of the times for the 5 bites be used as a single index without
concern about the variability between the 5 mosquitoes. The idea would
be that the average time for the first 5 landings would be the new
statistic used as the CPT.

฀࿾㟾$␸䠀$葝ﻠ葞ﻠ摧§!

☊଀Ɇ㜀$␸䠀$摧ᣝú

栂퀁ༀ킄ᄂ预㟾$␸䠀$葞ː葠ﺘ摧§!
ഀ׆Āː฀킄༂킄㜂$␸䠀$葝ː葞ː摧§!ᄀ	If so, would this
increased precision justify the incremental risk to the subjects
resulting from their exposure to a greater number of mosquito landings?

Yes. If each mosquito is aspirated off before it can bite, using the
first five will not increase the risk at all. The exact time of
aspiration would be required in order to calculate the statistic,
therefore, the volunteer would have to remain exposed for whatever
period was necessary following the first landing. In addition, it is
possible that the increased precision will actually decrease the
exposure of volunteers by reducing the number of replications required.

The increase in precision is probably essential if you are going to have
any hope of comparing studies performed at different times. The best
solution might be to apply Kramer’s suggestion of mean landing of five
mosquitoes to lab tests with standard strains, completely eliminating
risk to the volunteer and greatly increasing the precision of the test.
Field tests have so many variables that comparison of products compared
in separate field trials is hopelessly inaccurate. Field tests might
best be used to build confidence in real performance of a single
product, rather than as comparisons between products. It is important to
remember that the objective of the trials in question is labeling so
that consumers can compare products – not a guarantee or estimate of
protection from vector-borne pathogens.

Is it practical to test long-lasting repellents to the point of five
landings?

Yes. It is just a matter of applying them long enough before the tests
at 30 minute intervals on an adequate number of volunteers. All
volunteers could be tested simultaneously in order to minimize the
variability of the mosquito population caused by daily variation in
biting avidity. Even in the laboratory, avidity varies during the day.

There is a need for systematic evaluation of standardized test methods
in order to determine the exact procedures necessary to minimize
variability and maximize precision. Standardization will also help
prevent attempts by manufacturers to seek favorable results through the
use of particular field situations and procedures.

10/04/07

	Dr. Daniel Strickman’s Responses to Discussion Questions

 PAGE

 PAGE   1


[Federal Register Volume 85, Number 107 (Wednesday, June 3, 2020)]
[Proposed Rules]
[Pages 34118-34121]
[FR Doc No: 2020-11821]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0513; Product Identifier 2019-SW-037-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2018-08-01 for Airbus Helicopters Model EC225LP helicopters. AD 2018-
08-01 requires inspecting the control rod attachment yokes (yoke) of
certain main rotor rotating swashplates (swashplate). Since the FAA
issued AD 2018-08-01, Airbus Helicopters has identified additional
swashplate serial numbers affected by the unsafe condition and has
established a life limit for the swashplates. This proposed AD would
retain the inspection requirements of AD 2018-08-01, expand the
applicability, establish a life limit, and add a one-time inspection of
stripped yokes. The actions of this proposed AD are intended to address
an unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 3,
2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address 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 https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0513; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Union Aviation Safety Agency (EASA) AD,
any comments received and other information. The street address for
Docket Operations is listed above. Comments will be available in the AD
docket shortly after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html.You may
view this referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views. The FAA also invites comments
relating to the economic, environmental, energy, or federalism impacts
that might result from adopting the proposals in this document. The
most helpful comments reference a specific portion of the proposal,
explain the reason for any recommended change, and include supporting
data. To ensure the docket does not contain duplicate comments,
commenters should send only one copy of written comments, or if
comments are filed electronically, commenters should submit only one
time.
    The FAA will file in the docket all comments received, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal,
the FAA will consider all comments received on or before the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this proposal in light of the
comments received.

Discussion

    The FAA issued AD 2018-08-01, Amendment 39-19254 (83 FR 17617,
April 23, 2018) (``AD 2018-08-01'') for Airbus Helicopters Model
EC225LP helicopters. AD 2018-08-01 requires, for certain serial-
numbered swashplates part number (P/N) 332A31-3074-00 and P/N 332A31-
3074-01, a repetitive visual inspection of the five yokes for a crack
and replacing the swashplate if there is a crack in any of the yokes.
    AD 2018-08-01 was prompted by EASA AD No. 2017-0191R2, dated
December 15, 2017 (EASA AD 2017-0191R2), issued by EASA, which is the
Technical Agent for the Member States of the European Union. EASA
advised of a finding by Airbus Helicopters that the yoke is susceptible
to cracking due to strain aging of the metal. EASA advised that this
condition, if not detected and corrected, could lead to structural
failure of a yoke, possibly resulting in loss of control of the
helicopter.

Actions Since AD 2018-08-01 Was Issued

    Since the FAA issued AD 2018-08-01, Airbus Helicopters revised the
related service information, Emergency Alert Service Bulletin (EASB)
No. 05A051, Revision 1, dated November 16, 2017, to Revision 2, dated
February 26, 2019 (EASB 05A051). EASB 05A051 establishes a life limit
(also called a service life limit) of 12 years for the swashplate and
adds a reporting requirement if there is a crack or corrosion in a
yoke.
    Thereafter, EASA superseded EASA AD 2017-0191R2 with EASA AD No.
2019-0074, dated March 28, 2019 (EASA AD 2019-0074). EASA advises that
additional analysis determined that it is necessary to introduce a new
life limit for the affected swashplates. Accordingly, EASA AD 2019-0074
retains the requirements of EASA AD 2017-0191R2 and adds the life limit
and the reporting requirement.
    Additionally, the FAA issued AD 2018-08-01 to address the unsafe
condition of a crack in a swashplate yoke. However, AD 2018-08-01 did
not require stripping certain yokes and performing a one-time
inspection within 100 hours time-in-service (TIS) for corrosion and a
crack as specified in EASA AD 2017-0191R2, as there is sufficient time
to allow for notice and comment prior to this long-term AD requirement
going into effect. The FAA has determined this inspection is needed to
address this unsafe condition and has proposed to require, within 100
hours TIS and for certain yokes, removing the grease and stripping
certain areas of the yokes and inspecting these areas for corrosion,
pitting, loss of material, and a crack in this proposed AD.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that an
unsafe condition is likely to exist or develop on other helicopters of
the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed one document that co-publishes two Airbus
Helicopters EASB identification numbers: EASB 05A051 for Model EC225LP
helicopters and EASB No. 05A046, Revision 2, dated February 26, 2019,
for non-FAA type-certificated Model EC725AP helicopters. EASB 05A051 is
proposed for incorporation by reference in this proposed AD. Airbus
Helicopters EASB No. 05A046 is not proposed for incorporation by
reference in this proposed AD.
    This service information specifies inspections for swashplate P/N
332A31-3074-00 and P/N 332A31-3074-01. This service information
specifies procedures for a repetitive inspection of the yokes for a
crack and a one-time inspection of the stripped yokes for corrosion and
a crack. If in doubt about whether there is a crack, this service
information specifies performing a non-destructive inspection. This
service information also specifies touching up the swashplate with
varnish if there is corrosion, removing any damage within

allowable limits, and refinishing the yokes. If there is a crack in a
yoke, this service information specifies replacing the swashplate. This
service information also specifies a life limit of 12 years since the
date of manufacture for the swashplates and reporting requirements if a
crack or corrosion is discovered.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed one document that co-publishes two Airbus
Helicopters EASB identification numbers: No. 05A051 for Model EC225LP
helicopters and No. 05A046 for non-FAA type-certificated Model EC725AP
helicopters, each Revision 1 and dated November 16, 2017. Revision 1 of
this service information specifies the same inspections as Revision 2
of this service information. However, Revision 2 of this service
information clarifies some of the inspection instructions and adds a
life limit and a reporting requirement.

Proposed AD Requirements

    This proposed AD would require, before further flight, reviewing
Appendix 4.A. of EASB 05A051 to determine the date of manufacture of
the swashplate and establishing a life limit of 12 years since the date
of manufacture. This proposed AD would retain the repetitive visual
inspections of AD 2018-08-01 to inspect each yoke for a crack at
intervals not to exceed 15 hours time-in-service for swashplates that
have accumulated less than 7 years since the date of manufacture. For a
swashplate that has accumulated 7 or more years, but less than 12
years, since the date of manufacture, this proposed AD would require
removing the grease and stripping certain areas of the yokes and
inspecting these areas for corrosion, pitting, loss of material, and a
crack. If there are no cracks, this AD would require performing a dye
penetrant inspection of the yoke for a crack.
    Depending on the results of this inspection, the proposed AD would
require either repairing the surface of the swashplate or removing it
from service.

Differences Between This Proposed AD and the EASA AD

    The EASA AD requires performing a non-destructive inspection only
if there is doubt whether there is a crack. Instead, this proposed AD
requires a visual inspection and if there are no cracks, requires a
non-destructive inspection. The EASA AD specifies instructions for
reporting inspection reports; this proposed AD does not.

Costs of Compliance

    The FAA estimates that this proposed AD affects 26 helicopters of
U.S. Registry. The FAA estimates that operators may incur the following
costs in order to comply with this proposed AD. Labor costs are
estimated at $85 per work-hour.
    Determining the date of manufacture of the swashplate would take
about 0.5 work-hour for an estimated cost of $43 per helicopter and
$1,118 for the U.S. fleet.
    Inspecting the yokes would take about 0.25 work-hour for an
estimated cost of $21 per helicopter and $546 for the U.S. fleet per
inspection cycle.
    Removing grease, stripping the yokes, and inspecting the stripped
yokes would take about 8 work-hours, for a total estimated cost of $680
per helicopter.
    Dye-penetrant inspecting a yoke for a crack would take about 6
work-hours and parts would cost about $50, for an estimated cost of
$560 per yoke.
    Removing any corrosion or repairing damage within the allowable
limit would take about 3 work-hours, for an estimated cost of $255 per
yoke.
    Replacing the swashplate would take about 6 work-hours, and parts
would cost about $85,661 for an estimated cost of $86,171 per instance.

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.
    The FAA is 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

    The FAA 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, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,
    2. Will not affect intrastate aviation in Alaska, and
    3. 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)
2018-08-01, Amendment 39-19254 (83 FR 17617, April 23, 2018), and
adding the following new AD:

Airbus Helicopters: Docket No. FAA-2020-0513; Product Identifier
2019-SW-037-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model EC225LP helicopters,
certificated in any category, with a main rotor (M/R) rotating
swashplate (swashplate) part number (P/N) 332A31-3074-00 or P/N
332A31-3074-01 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a swashplate
control rod attachment yoke (yoke). This condition could result in
failure of the yoke, loss of M/R control, and subsequent loss of
control of the helicopter.

(c) Affected ADs

    This AD replaces AD 2018-08-01, Amendment 39-19254 (83 FR 17617,
April 23, 2018).

(d) Comments Due Date

    The FAA must receive comments by August 3, 2020.

(e) Compliance

    You are responsible for performing each action required by this
AD within the

specified compliance time unless it has already been accomplished
prior to that time.

(f) Required Actions

    Before further flight, review Appendix 4.A. of Airbus
Helicopters Emergency Alert Service Bulletin No. 05A051, Revision 2,
dated February 26, 2019 (EASB 05A051) to determine the date of
manufacture of the swashplate.
    (1) If the swashplate has accumulated 12 or more years since the
date of manufacture, remove from service the swashplate.
    (2) If the swashplate has accumulated less than 12 years since
the date of manufacture, create a component history card or
equivalent record indicating a life limit of 12 years since the date
of manufacture. Thereafter, continue to record the life limit of the
swashplate on its component history card or equivalent record and
remove from service any swashplate before accumulating 12 years
since the date of manufacture.
    (3) For each swashplate that has accumulated less than 7 years
since the date of manufacture, within 15 hours time-in-service (TIS)
and thereafter at intervals not to exceed 15 hours TIS, until the
swashplate accumulates 7 years since the date of manufacture,
visually inspect each yoke for a crack, paying particular attention
to the areas shown in Details B, C, and D of Figure 1 of EASB
05A051.
    (i) If there are no cracks, perform a dye penetrant inspection
of the yoke for a crack.
    (ii) If there is a crack on a yoke, before further flight,
remove from service the swashplate.
    (4) For each swashplate that has accumulated 7 or more years,
but less than 12 years, since the date of manufacture, within 100
hours TIS:
    (i) Remove the grease from areas (E), (F), (G), (H), (J), and
(K) of each yoke as shown in Details B, C, and D of Figure 1 of EASB
05A051. Using a plastic spatula, strip areas (E), (F), (G), (H),
(J), and (K) of each yoke as shown in Details B, C, and D of Figure
1 of EASB 05A051. Do not use a metal tool to strip any area of a
yoke.
    (ii) Inspect areas (E), (F), (G), (H), (J) and (K) of each yoke
as shown in Details B, C, and D of Figure 1 of EASB 05A051 for
corrosion, pitting, and loss of material.
    (A) If there is any corrosion less than 0.0078 in. (0.2 mm),
before further flight, remove the corrosion and apply varnish
(Vernelec 43022 or equivalent) to the surface of areas (E), (F),
(G), (H), (J) and (K).
    (B) If there is any pitting or loss of material of less than
0.0078 in. (0.2 mm), before further flight, remove the damage by
sanding with sandpaper 200/400 or 330.
    (C) If there is any corrosion, pitting, or loss of material of
0.0078 in. (0.2 mm) or greater, before further flight, remove from
service the swashplate.
    (iii) Visually inspect each yoke for a crack, paying particular
attention to the areas shown in Details B, C, and D of Figure 1 of
EASB 05A051.
    (A) If there are no cracks, perform a dye penetrant inspection
of the yoke for a crack.
    (B) If there is a crack on a yoke, before further flight, remove
from service the swashplate.

 (g) Credit for Previous Actions

    If you performed the actions in paragraph (f)(4) before the
effective date of this AD using Airbus Helicopters Emergency Alert
Service Bulletin No. 05A051, Revision 1, dated November 16, 2017,
you met the requirements of paragraph (f)(4) of this AD.

 (h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Matt Fuller, Senior Aviation Safety Engineer, Safety Management
Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(i) Additional Information

    The subject of this AD is addressed in European Union Aviation
Safety Agency (EASA) AD No. 2019-0074, dated March 28, 2019. You may
view the EASA AD on the internet at https://www.regulations.gov in
the AD Docket.

(j) Subject

    Joint Aircraft Service Component (JASC) Code: 6230, Main Rotor
Mast/Swashplate.

    Issued on May 27, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-11821 Filed 6-2-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Pages 5007-5008]
[FR Doc No: 2023-01567]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Statement of Organization, Functions, and Delegations of
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA), Office of Operations
(OO), Office of Talent Solutions (OTS) has modified its structure, and
the Office of FDA Commissioned Corps (OFCC) was established. These new
organizational structures were approved by the Deputy Secretary of
Health and Human Services on September, 26, 2022, and effective on
November, 2, 2022.

FOR FURTHER INFORMATION CONTACT: Tiffany Branch, Associate Director for
Management, Office of Enterprise Management Services, Office of
Operations, Food and Drug Administration, 3 White Flint North, 11601
Landsdown Street, North Bethesda, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Part D, Chapter D-B, (Food and Drug Administration), the Statement
of Organization, Functions and Delegations of Authority for the
Department of Health and Human Services (35 FR 3685, February 25, 1970,
60 FR 56606, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August 18, 2009, 76 FR 45270, July 28,
2011, and 84 FR 22854, May 20, 2019) is amended to reflect the
reorganization of the OO, OTS and establishment of OO, OFCC.
    This reorganization established the OO, OFCC. In the OTS immediate
office realigned the Commissioned Corps Staff (CCS) functions and
resources to OO, OFCC; established the Business Operations Staff;
retitled the Policy and Accountability Staff to Policy, Programs, and
Accountability Staff; and abolished the CCS.
    In the Division of Talent Services, I (DTS I) retitled the division
to Division of Talent Solutions I (DTS I); retitled the CDER Branch 1
to Recruitment and Staffing Branch 1; retitled the CDER Branch 2 to
Recruitment and Staffing Branch 2; retitled the CDER Branch 3 to
Recruitment and Staffing Branch 3 (RSB3); established the Recruitment
and Staffing Branch 4; and established the Special Pay and Hiring
Branch.
    In the Division of Talent Services II (DTS II) retitled the
division to Division of Talent Solutions II (DTS II); retitled the
CFSAN and CVM Branch to Recruitment and Staffing Branch 5; retitled OC
and NCTR Branch to Recruitment and Staffing Branch 6; retitled the OO
Branch to Recruitment and Staffing Branch 7; established the
Classification Branch 1; and established the Classification Branch 2.
    In the Division of Talent Services III (DTS III) retitled the
division to Division of Talent Solutions III (DTS III); realigned the
CBER Branch functions and resources to DTS I/RSB3; realigned the CDRH
Branch functions and resources to DTS II and retitled as Recruitment
and Staffing Branch 8; realigned the CTP Branch functions and resources
to DTS II and retitled as Recruitment and Staffing Branch 9;
established the OTS/DTS III/Data Quality Branch 2; established the Data

Quality Branch 3; and established Data Quality Branch 4.
    In the Division of Talent Services IV (DTS IV) realigned the ORA
Branch 1 functions to DTS III and retitled as the Recruitment and
Staffing Branch 10; realigned the ORA Branch 2 functions to DTS III and
retitled as the Recruitment and Staffing Branch 11; and abolished DTS
IV.
    In the Division of Talent Sourcing and Staffing (DTSS) realigned
the Corporate Recruitment and Title 38 Branch functions and resources
to the OTS Immediate Office Executive Resources Staff and retitled as
the Scientific Programs and Executive Resources Staff; realigned the
Scientific Staffing and Outreach Branch functions and resources to the
OTS Immediate Office Scientific Talent Recruitment Staff and retitled
as the Science, Technology, Engineering, and Mathematics Outreach
Staff; realigned the Customer Care and Data Quality Branch functions
and resources to DTS III and retitled as the Data Quality Branch 1; and
abolished DTSS.
    Under Part D, FDA, OO, OTS has been restructured as follows:
    DCNJ. ORGANIZATION. The Office of Talent Solutions is headed by the
FDA Chief Talent Officer and includes the following organizational
units:

Business Operations Staff
Policy, Programs, and Accountability Staff
Scientific Programs and Executive Resources Staff
Science, Technology, Engineering, and Mathematics Outreach Staff
Division of Talent Solutions I
    Recruitment and Staffing Branch 1
    Recruitment and Staffing Branch 2
    Recruitment and Staffing Branch 3
    Recruitment and Staffing Branch 4
    Special Hiring and Pay Branch
Division of Talent Solutions II
    Recruitment and Staffing Branch 5
    Recruitment and Staffing Branch 6
    Recruitment and Staffing Branch 7
    Recruitment and Staffing Branch 8
    Recruitment and Staffing Branch 9
    Classification Branch 1
    Classification Branch 2
Division of Talent Solutions III
    Recruitment and Staffing Branch 10
    Recruitment and Staffing Branch 11
    Delegated Examining Branch
    Data Quality Branch 1
    Data Quality Branch 2
    Data Quality Branch 3
    Data Quality Branch 4

    Under Part D, FDA, OO has been restructured as follows:
    DCNK. ORGANIZATION. The Office of FDA Commissioned Corps (OFCC) is
headed by the Director of FDA Commissioned Corps.

II. Delegations of Authority

    Pending further delegation, directives, or orders by the
Commissioner of Food and Drugs, all delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegations, provided they are consistent with this reorganization.

III. Electronic Access

    This reorganization is reflected in FDA's Staff Manual Guide (SMG).
Persons interested in seeing the complete SMG can find it on FDA's
website at: http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm

(Authority: 44 U.S.C. 3101.)

Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2023-01567 Filed 1-25-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 16, 2006 (Volume 71, Number 199)]
[Notices]
[Page 60781-60782]
[DOCID:fr16oc06-108]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54580; File No. SR-ISE-2006-40]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Order Approving Proposed Rule Change and Amendment No. 1 Thereto
Relating to the Establishment of the Second Market

 October 6, 2006.

I. Introduction

    On July 5, 2006, the International Securities Exchange, LLC (f/k/a
the International Securities Exchange, Inc.) (``ISE'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposal to establish a
``Second Market'' for the listing and trading of low-volume option
classes. On August 16, 2006, ISE filed Amendment No. 1 to the proposed
rule change.\3\ The proposed rule change, as amended, was published for
comment in the Federal Register on August 29, 2006.\4\ The Commission
received no comments regarding the proposal. This order approves the
proposed rule change, as amended.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced and superseded the original filing
in its entirety.
    \4\ See Securities Exchange Act Release No. 54340 (August 21,
2006), 71 FR 51240.
---------------------------------------------------------------------------

II. Description of the Proposal

    The ISE proposes to adopt rules for the listing and trading of low-
volume option classes that qualify for listing under existing Exchange
standards in a ``Second Market.'' Historically, the Exchange has
elected to refrain from trading many option classes that qualify for
trading on the ISE, but are characterized by low average daily trading
volumes (``ADVs'') on the other option exchanges.

A. Listing in the Second Market

    Under the proposal, the Exchange would be able to list in the
Second Market equity option classes (excluding options on exchange
traded funds) that trade on other option exchange(s) that are
characterized by an ADV below 500 contracts over the previous six-month
period. The proposed rules would allow the Exchange to list equity
option classes with an ADV of over 1,500 contracts only in the existing
market (the ``First Market''), and would trade such classes pursuant to
existing ISE rules. The Exchange would be able to list option classes
with an ADV between 500 and 1,500 contracts initially in either market.
Starting one year after the Exchange initiates trading in the Second
Market, the Exchange would review the market in which option classes
are listed every three months, and option classes would be moved from
the First to the Second Market when their ADV in the prior six-month
period falls below 300 contracts, and moved from the Second to the
First Market when their ADV in the prior six-month period exceeds 750
contracts.

B. Participation as Market Makers in the Second Market

    Under the proposal, all members approved to operate ISE market
maker memberships would be eligible to be Competitive Market Makers in
the Second Market (``SMCMMs''). In addition, members that are only
approved as Electronic Access Members (``EAMs'') may also register as
SMCMMs.\5\ Only Primary Market Makers in the First Market may be
Primary Market Makers in the Second Market (``SMPMMs'').
---------------------------------------------------------------------------

    \5\ Under the proposed rules, members that are only EAMs that
want to become SMCMMs would be required to complete the same market
maker application and meet the same standards that are applied to
Competitive Market Makers under the Exchange's existing rules.
Members that are only EAMs are not eligible to be SMPMMs.
---------------------------------------------------------------------------

    As in the First Market, a primary market maker would be appointed
for each class traded in the Second Market. SMPMMs would be subject to
all the same obligations in their appointed options as Primary Market
Makers in the First Market, including, among other things, entering
continuous quotations in each series of every option class to which
they are appointed and satisfying requirements related to the Plan for
Creating and Operating an Intermarket Option Linkage. Similar to
Primary Market Makers in the First Market, SMPMMs would be permitted to
execute no more than 10% of their volume in Second Market option
classes to which they are not assigned.
    For purposes of existing Exchange rules relating to market maker
obligations, SMCMMs will be considered ``appointed'' to all option
classes listed in the Second Market and will be able to choose whether
to make markets in any option class listed in the Second Market on a
daily basis. Unlike Competitive Market Makers in the First Market,
SMCMMs would not be required to enter continuous quotations in a
minimum number or percentage of assigned option classes. An SMCMM will
be required to continuously quote

all of the series of any options class in which it chooses to make a
market. If an SMCMM chooses to make markets in one or more options
classes in the Second Market, it must participate in the opening
rotation and make markets and enter into any resulting transactions on
a continuous basis in all series of the options class until the close
of trading that day. SMCMMs may not initiate quoting in an options
class intraday. In addition, an SMCMM would undertake all the
obligations that a Competitive Market Maker in the First Market assumes
in appointed option classes for any option class(es) in which the SMCMM
elects to make a market on a given day. SMCMMs will be permitted to
execute no more than 25% of their volume in Second Market option
classes in which they are not contemporaneously making markets.

C. Proposed Fees in the Second Market

    The Exchange proposes several changes to its fee schedule to
accommodate introduction of the Second Market as follows: (1) Members
would be charged an execution fee of $.05 per contract for public
customer orders; (2) a $.10 per contract surcharge would be applied to
transactions executed by market makers that do not own or lease an ISE
market maker membership (i.e., EAMs that make markets in the Second
Market); (3) market makers would be excluded from the $0.65 per
contract payment for order flow fee for Second Market options; (4) all
market makers in the Second Market would be charged a $2,000 per month
access fee (there would be no additional access fee for EAMs to send
orders to the Second Market); and (5) firms that are only market makers
in the Second Market (i.e., EAMs that make markets in the Second
Market) would be charged the same $5,000 annual regulatory fee paid by
Competitive Market Makers in the First Market.

III. Discussion

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange \6\ and, in particular, the requirements of Section
6 of the Act.\7\ Specifically, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\8\ which
requires, among other things, that the rules of a national securities
exchange be designed to prevent fraudulent and manipulative acts and
practices, 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.
---------------------------------------------------------------------------

    \6\ In approving this proposed rule change, as amended, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the ISE proposed market maker
obligations for SMPMMs and SMCMMs are consistent with the Act. Market
Makers are accorded certain benefits under the securities laws and ISE
rules. The Commission believes the obligations of Market Makers in the
Second Market justify these benefits.
    The Commission also believes that the proposal is consistent with
Section 6(b)(4) of the Act,\9\ which requires that the rules of a
national securities exchange provide for the equitable allocation of
reasonable dues, fees, and other charges among the Exchange's members
and issuers and other persons using its facilities. The Exchange
currently assesses no execution fee for public customer order, but
proposes to assess a $0.05 per contract execution fee for public
customer orders executed in the Second Market. The Commission believes
that this assessment is reasonable. The proposed rule change also
appears to be reasonably designed to avoid duplicative charges to
market makers already assessed certain fees, such as transaction and
regulatory fees. The surcharge for Second Market transactions and the
market maker regulatory fee will apply only to SMCMMs that are not also
Market Makers in the First Market.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (File No. SR-ISE-2006-40), as
amended, is hereby approved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).
    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
Nancy M. Morris,
Secretary.
[FR Doc. E6-17083 Filed 10-13-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Page 38265]
[FR Doc No: 2011-16283]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending June 4,
2011

    The following Agreements were filed with the Department of
Transportation under the Sections 412 and 414 of the Federal Aviation
Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.
    Docket Number: DOT-OST-2011-0103.
    Date Filed: May 31, 2011.
    Parties: Members of the International Air Transport Association.
    Subject: TC23/123 Europe-South West Pacific, Mail Vote 684
Adoption, Composite Resolutions 017jj & 017h, e-Tariffs, 2-20 May 2011,
Intended Effective Date: 1 September 2011.

 Renee V. Wright,
 Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2011-16283 Filed 6-28-11; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 82, Number 15 (Wednesday, January 25, 2017)]
[Notices]
[Pages 8422-8423]
[FR Doc No: 2017-01632]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-62-000.
    Applicants: NSTAR Electric Company, Western Massachusetts Electric
Company.
    Description: Application For Approval of Internal Corporate
Reorganization under Section 203 of the FPA of NSTAR Electric Company,
et al.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5237.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: EC17-63-000.
    Applicants: 62SK 8ME LLC, 63SU 8ME LLC, Balko Wind, LLC, Balko Wind
Transmission, LLC, North Star Solar PV LLC, Portal Ridge Solar B, LLC,
Portal Ridge Solar C, LLC, Red Horse Wind 2, LLC, Red Horse III, LLC,
TPE Alta Luna, LLC.
    Description: Application for Authorization of Transaction under
Section 203 of the FPA of 62SK 8ME LLC.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5240.
    Comments Due: 5 p.m. ET 2/3/17.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG17-44-000.
    Applicants: SolaireHolman 1 LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of SolaireHolman 1 LLC.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5087.
    Comments Due: 5 p.m. ET 2/3/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER16-1983-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2013-01-13 Petition Limited Tariff
Waiver Delay Implementation RTD LMPM to be effective N/A.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5201.
    Comments Due: 5 p.m. ET 1/20/17.

    Docket Numbers: ER17-79-002.
    Applicants: Portland General Electric Company.
    Description: Compliance filing: Combined Order 827 and 828
Amendment Filing to be effective 10/14/2016.
    Filed Date: 1/17/17.
    Accession Number: 20170117-5033.
    Comments Due: 5 p.m. ET 2/7/17.

    Docket Numbers: ER17-210-003.
    Applicants: Sabine Cogen, LP.
    Description: Compliance filing: Complaince Filing to be effective
1/1/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5168.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-556-000.
    Applicants: Grady Wind Energy Center, LLC.
    Description: Supplement to December 15, 2016 Grady Wind Energy
Center, LLC tariff filing.
    Filed Date: 1/12/17.
    Accession Number: 20170112-5142.
    Comments Due: 5 p.m. ET 2/2/17.

    Docket Numbers: ER17-792-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Sec.  205(d) Rate Filing: Filing of Modifications to
Agreement to be effective 3/15/2017.

    Filed Date: 1/13/17.
    Accession Number: 20170113-5162.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-793-000.
    Applicants: Westar Energy, Inc.
    Description: Sec.  205(d) Rate Filing: Modification to TFR Template
for AROs to Comply with Audit Report to be effective 3/14/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5172.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-794-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Certificate of Concurrence
CAISO Amended TCA Docket No. ER17-694-000 to be effective 3/1/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5198.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-795-000.
    Applicants: ISO New England Inc.
    Description: Sec.  205(d) Rate Filing: Filing of CONE and ORTP
Updates to be effective 3/15/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5199.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-796-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
Consumers Energy Company.
    Description: Sec.  205(d) Rate Filing: 2017-01-12 SA 2913
Wolverine-Consumers FCA Termination to be effective 1/14/2017.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5205.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-797-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-01-13_Entergy
Interconnection Agreement 2017 Succession Filing to be effective 12/19/
2013.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5213.
    Comments Due: 5 p.m. ET 2/3/17.

    Docket Numbers: ER17-798-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Tariff Cancellation: DEF SA Cancellation Filing to be
effective 1/18/2017.
    Filed Date: 1/17/17.
    Accession Number: 20170117-5131.
    Comments Due: 5 p.m. ET 2/7/17.

    Docket Numbers: ER17-799-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: PSCo-HLYCRS-354-NOC to be
effective 1/18/2017.
    Filed Date: 1/17/17.
    Accession Number: 20170117-5134.
    Comments Due: 5 p.m. ET 2/7/17.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES17-10-000.
    Applicants: NSTAR Electric Company.
    Description: Application of NSTAR Electric Company under Section
204 of the FPA for Authority to Assume Short-Term Debt Obligations of
its affiliate, Western Mass Electric Company.
    Filed Date: 1/13/17.
    Accession Number: 20170113-5238.
    Comments Due: 5 p.m. ET 2/3/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 17, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-01632 Filed 1-24-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 17, 2008 (Volume 73, Number 243)]
[Notices]
[Page 76629]
[DOCID:fr17de08-63]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL09-15-000]

City of Vernon, CA; Notice of Filing

December 10, 2008.
    Take notice that on December 4, 2008, City of Vernon, California
filed annual revision to its Transmission Revenue Balancing Account
Adjustment, to become effective January 1, 2009, consistent with its
Transmission Owner Tariff filed with the Federal Energy Regulatory
Commission in Docket Nos. EL00-105 and EL08-54, and the California
Independent System Operator Corporation Electric Tariff.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 5, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-29865 Filed 12-16-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Notices]
[Pages 72010-72011]
[FR Doc No: 2011-29873]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:

    Rule 6e-2 and Form N-6EI-1; SEC File No. 270-177; OMB Control
No. 3235-0177.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Rule 6e-2 (17 CFR 270.6e-2) under the Investment Company Act of
1940 (``Act'') (15 U.S.C. 80a) is an exemptive rule that provides
separate accounts formed by life insurance companies to fund certain
variable life insurance products, exemptions from certain provisions of
the Act, subject to conditions set forth in the rule. The rule sets
forth several information collection requirements.
    Rule 6e-2 provides a separate account with an exemption from the
registration provisions of section 8(a) of the Act if the account files
with the Commission Form N-6EI-1 (17 CFR 274.301), a notification of
claim of exemption.
    The rule also exempts a separate account from a number of other
sections of the Act, provided that the separate account makes certain
disclosure in its registration statements (in the case of those
separate account that elect to register), reports to contract holders,
proxy solicitations, and submissions to state regulatory authorities,
as prescribed by the rule.
    Paragraph (b)(9) of rule 6e-2 provides an exemption from the
requirements of section 17(f) of the Act and imposes a reporting burden
and certain other conditions. Section 17(f) requires that every
registered management company meet various custody requirements for its
securities and similar investments. The exemption provided in paragraph
(b)(9) applies only to management accounts that offer life insurance
contracts.
    Since 2008, there have been no filings under paragraph (b)(9) of
rule 6e-2 by management accounts. Therefore, there has been no cost or
burden to the industry regarding the information collection
requirements of paragraph (b)(9) of rule 6e-2. In addition, there have
been no filings of Form N-6EI-1 by separate accounts. The Commission
requests authorization to maintain an inventory of one burden hour for
administrative purposes.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, http://www.reginfo.gov. Comments should be directed to: (i) Desk Officer for
the Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503, or by sending an email
to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312 or send an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB
within 30 days of this notice.

    Dated: November 14, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-29873 Filed 11-18-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: February 28, 2008 (Volume 73, Number 40)]
[Notices]
[Page 10756-10757]
[DOCID:fr28fe08-57]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF08-6-000]

Columbia Gas Transmission; Notice of Intent To Prepare an
Environmental Assessment for the Planned Ohio Storage Expansion Project
and Request for Comments on Environmental Issues

February 22, 2008.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the potential environmental impacts of the Ohio Storage
Expansion Project, involving construction and operation of natural gas
facilities by Columbia Gas Transmission (Columbia) in Ashland,
Fairfield, Hocking, and Holmes Counties, Ohio. The EA will be used by
the Commission in its decision-making process to determine whether the
project is in the public convenience and necessity.
    This notice announces the opening of the scoping period that will
be used to gather environmental input from the public and interested
agencies on the project. Your input will help the Commission staff
determine which issues need to be evaluated in the EA. Please note that
the scoping period will close on April 7, 2008. Instructions on how to
submit comments are provided in the Public Participation section of
this notice.
    If you are a landowner receiving this notice, you may be contacted
by a Columbia representative about the acquisition of an easement to
construct, operate, and maintain the planned project facilities. The
pipeline company would seek to negotiate a mutually acceptable
agreement. However, if the project is approved by the Commission, that
approval conveys with it the right of eminent domain. Therefore, if
easement negotiations fail to produce an agreement, Columbia could
initiate condemnation proceedings in accordance with Ohio state law.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility on My Land? What Do I Need to Know?'' addresses a number
of typically asked questions, including the use of eminent domain and
how to participate in the Commission's proceedings. It is available for
viewing on the FERC Internet Web site (http://www.ferc.gov).
    With this notice, we \1\ are inviting other Federal, State, local,
and tribal agencies with jurisdiction and/or special expertise with
respect to environmental issues to cooperate with us in the preparation
of the EA. Agencies that would like to request cooperating status
should follow the instructions for filing comments provided below.
---------------------------------------------------------------------------

    \1\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the FERC's Office of Energy Projects.
---------------------------------------------------------------------------

Summary of the Proposed Project

    Within the Crawford Storage Field (Fairfield and Hocking Counties,
Ohio), Columbia seeks authorization to:
     Construct 16 new storage wells;
     Convert 11 existing counter storage wells to active
storage wells;
     Convert 10 existing observation wells to counter or active
storage wells,;
     Convert 2 high pressure wells to counter storage wells;
     Purchase 6 production wells and convert to storage wells;
     Install 13.6 miles of interconnecting pipeline; and
     Make minor modifications at Columbia's Crawford Compressor
Station.
    Within the Weaver Storage Field (Ashland and Holmes Counties,
Ohio), Columbia seeks authorization to:
     Construct 4.1 miles of field storage pipeline;
     Replace 1.7 miles of field storage pipeline;
     enhance the deliverability work on 26 existing storage
wells;
     Install one gate valve setting;
     Install a measurement station; and
     Install a regulation station.
    The storage project would provide an additional 103,400 dekatherms
per day of storage deliverability for service in the eastern United
States. Appendix A presents detailed maps identifying all facilities
associated with this project.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies are available on the
Commission's Internet Web site (http://www.ferc.gov) at the
``eLibrary'' link or from the Commission's Public Reference Room at
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the ``Additional Information'' section at the end of this notice.
Copies of the appendices are being sent to all those receiving this
notice in the mail. Requests for detailed maps of the facilities
should be made directly to Dominion.
---------------------------------------------------------------------------

Land Requirements for Construction

    For new well installation, Columbia would disturb a 400-foot-
square. For reconditioned wells, a 300-foot-square would be necessary.
Columbia plans to use between a 50-foot and 70-foot-wide construction
right-of-way for installation of its pipelines (ranging from 4 to 10
inches in diameter). Based on preliminary information, construction of
the pipelines and storage facilities would disturb about 359 acres of
land. Following construction, about 331 acres would be maintained as
permanent right-of-way. The remaining temporary workspace would be
restored and allowed to revert to its former use.

The EA Process

    We are preparing this EA to comply with the National Environmental
Policy Act of 1969 (NEPA) which requires the Commission to take into
account the environmental impacts that could result from an action
whenever it considers the issuance of a Certificate of Public
Convenience and Necessity. NEPA also requires us to discover and
address concerns the public may have about proposals. This process is
referred to as ``scoping.'' The main goal of the scoping process is to
focus the analysis in the EA on the important environmental issues. By
this notice, we are requesting public comments on the scope of the
issues to be addressed in the EA. All comments received will be
considered during the preparation of the EA. As part of our Pre-Filing
review, Columbia previously sponsored public open houses in the project
areas to explain its project, the environmental review process, and
take comments about the

project from interested stakeholders (January 23 and 24, 2008).
    The EA will discuss impacts that could occur as a result of the
construction and operation of the planned project under the following
general headings:
     Geology and soils;
     Water resources;
     Wetlands;
     Vegetation, fisheries, and wildlife (including threatened
and endangered species);
     Cultural resources;
     Land use and visual quality;
     Air quality and noise; and
     Reliability and safety.
    We note that 12 of the wells to be reconditioned in the Weaver
Storage Field are located within the boundary of Mohican Memorial State
Forest. Further, construction of the Ohio Storage Expansion Project
would require the removal of potential Indiana bat roost trees.
Additionally, we will evaluate possible alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    Our independent analysis of the issues will be presented in the EA.
Depending on the comments received during the scoping process, the EA
may be published for distribution and mailed to federal, state, and
local agencies; elected officials; public interest groups; interested
individuals; affected landowners; newspapers and libraries in the
project area; and the Commission's official service list for this
proceeding. A comment period will be allotted for review if the EA is
published. We will consider all comments on the EA before we make our
recommendations to the Commission.
    Although no formal application has been filed, the FERC staff has
already initiated its NEPA review under the Commission's Pre-Filing
Process. The purpose of the Pre-Filing Process is to encourage the
early involvement of interested stakeholders and to identify and
resolve issues before an application is filed with the FERC.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. By becoming a commenter, your
concerns will be addressed in the EA and considered by the Commission.
Your comments should focus on the potential environmental effects of
the proposal, reasonable alternatives (including alternative locations
and pipeline routes), and measures to avoid or lessen environmental
impact. The more specific your comments, the more useful they will be.
Please carefully follow these instructions to ensure that your comments
are received in time and properly recorded:
     Send an original and two copies of your letter to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Room 1A, Washington, DC 20426.
     Label one copy of the comments for the attention of Gas
Branch 1;
     Reference Docket No. PF08-6-000;
     Mail your comments so that they will be received in
Washington, DC on or before April 7, 2008.
    Please note that the Commission strongly encourages electronic
filing of comments. See Title 18 of the Code of Federal Regulations
(CFR) Part 385.2001(a)(1)(iii) and the instructions on the Commission's
Internet Web site at http://www.ferc.gov under the ``eFiling'' link and
the link to the User's Guide. Prepare your submission in the same
manner as you would if filing on paper and save it to a file on your
computer's hard drive. Before you can file comments you will need to
create an account by clicking on ``Login to File'' and then ``New User
Account.'' You will be asked to select the type of filing you are
making. This filing is considered a ``Comment on Filing.''
    We may mail the EA for comment. If you are interested in receiving
it, please return the Mailing List Form (Appendix B). If you do not
return the Mailing List Form, you will be removed from the mailing
list.
    Once Columbia formally files its application with the Commission,
you may want to become an official party to the proceeding known as an
``intervenor.'' Intervenors play a more formal role in the process and
are able to file briefs, appear at hearings, and be heard by the courts
if they choose to appeal the Commission's final ruling. An intervenor
formally participates in a Commission proceeding by filing a request to
intervene. Instructions for becoming an intervenor are included in the
User's Guide under the ``e-filing'' link on the Commission's Web site.
Please note that you may not request intervenor status at this time.
You must wait until a formal application is filed with the Commission.

Environmental Mailing List

    An effort is being made to send this notice to all individuals,
organizations, and government entities interested in and/or potentially
affected by the proposed project. This includes all landowners who are
potential right-of-way grantors, whose property may be used temporarily
for project purposes, or who own homes within distances defined in the
Commission's regulations of certain aboveground facilities. We
encourage government representatives to notify their constituents of
this proposed project and encourage them to comment on their areas of
concern.
    If you received this notice, you are on the environmental mailing
list for this project. If you do not want to send comments at this
time, but still want to remain on our mailing list, please return the
Mailing List Form (Appendix B). If you do not return the Information
Request, you will be removed from the Commission's environmental
mailing list.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs at 1-866-208 FERC (3372) or on
the FERC Internet Web site (http://www.ferc.gov). Using the
``eLibrary'' link, select ``General Search'' from the eLibrary menu,
enter the selected date range and ``Docket Number'' excluding the last
three digits (i.e., PF08-6), and follow the instructions. For
assistance with access to eLibrary, the helpline can be reached at 1-
866-208-3676, TTY<PHONE_NUMBER>, or at<EMAIL_ADDRESS>The
eLibrary link on the FERC Internet Web site also provides access to the
texts of formal documents issued by the Commission such as orders,
notices, and rule makings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.
    Finally, any public meetings or site visits will be posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/
EventsList.aspx along with other related information. You can also
request additional information by calling Kelly Merritt at Columbia at
(304) 357-2283.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-3755 Filed 2-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22687-22688]
[FR Doc No: 2014-09201]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0079]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Generic Drug
User Fee Act Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 23,
2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0632.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet--21 U.S.C.
379j-21 (OMB Control Number 0910-0632)--Revision

    Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 379j-21) establishes three different kinds of user
fees: (1) Fees for certain types of abbreviated applications for
generic new animal drugs, (2) annual fees for certain generic new
animal drug products, and (3) annual fees for certain sponsors of
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). Because concurrent submission of user fees with
applications is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3728 is the Animal Generic Drug
User Fee Act (AGDUFA) Cover Sheet, which is designed to provide the
minimum necessary information to determine whether a fee is required
for review of an application, to determine the amount of the fee
required, and to account for and track user fees.
    The Animal Generic Drug User Fee Amendments of 2013, signed by the
President on June 13, 2013 (AGDUFA II) (Title II of Pub. L. 113-14),
amended the FD&C Act authorizing FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, for certain
generic new animal drug products, and for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. To implement
changes under the reauthorization by their effective date of October 1,
2013, FDA sought and received OMB approval to update its Form FDA 3728
as described as follows:

    On page 1 of the electronic questions under ``Select an Application
Type'' users must select ``Original'' and then choose either,
``Abbreviated New Animal Drug Application (ANADA)--under provisions of
512(b)(2) of FFDCA [the FD&C Act]'' (21 U.S.C. 360b(b)(2)); or
``Abbreviated New Animal Drug Application (ANADA)--for certain
combination pioneer products approved under provisions of 512(d)(4) of
FD&C Act.'' If they select the first ANADA type, they will be charge
100 percent of the application fee. If they select the second ANADA
type, they will be charged at a rate of 50 percent of the original
application fee. To facilitate the application process in this regard,
on Form FDA 3728 we have added a line in section 3 that allows
applicants to select the option, ``3.2 Original Abbreviated New Animal
Drug Application (ANADA)--for certain combination pioneer products
approved under provisions of section 512(d)(4) of the FD&C Act.''
    In the Federal Register of February 18, 2014 (79 FR 9224), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
                  FDA form No.                      Number of      responses per     Total annual       Average burden per response        Total hours
                                                   respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3728...........................................              20                2               40   .08 (4.8 minutes)..................             3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are generic animal
drug applicants. Based on data for the past 3 years, FDA estimates
there are approximately 20 submissions annually and a total of 3.2
burden hours.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09201 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P