[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Notices]
[Pages 60124-60127]
[FR Doc No: 2011-24899]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2011-0110]

Tesla Motors, Inc.; Grant of Petition for Temporary Exemption
From the Electronic Stability Control Requirements of FMVSS No. 126

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of grant of a petition for temporary exemption from
Federal Motor Vehicle Safety Standard (FMVSS) No. 126, Electronic
Stability Control Systems.

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SUMMARY: This notice grants the petition of Tesla Motors, Inc. (Tesla)
for the temporary exemption of its Roadster model from the electronic
stability control requirements of FMVSS No. 126. The basis for the
exemption is that the exemption would facilitate the development or
field evaluation of a low-emission motor vehicle and would not
unreasonably reduce the safety level of that vehicle.

DATES: The exemption is effective September 28, 2011, and remains in
effect until November 7, 2011.

FOR FURTHER INFORMATION CONTACT: David Jasinski, Office of the Chief
Counsel, NCC-112, National Highway Traffic Safety Administration, 1200
New Jersey Avenue, SE., West Building 4th Floor, Room W41-326,
Washington, DC 20590. Telephone:<PHONE_NUMBER>; Fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Statutory Basis for Temporary Exemptions

    The National Traffic and Motor Vehicle Safety Act (Safety Act),
codified as 49 U.S.C. Chapter 301, authorizes the Secretary of
Transportation to exempt, on a temporary basis and under specified
circumstances, motor vehicles from a motor vehicle safety standard or
bumper standard. This authority is set forth at 49 U.S.C. 30113. The
Secretary has delegated the authority in this section to NHTSA.
    NHTSA established 49 CFR part 555, Temporary Exemption from Motor
Vehicle Safety and Bumper Standards, to implement the statutory
provisions concerning temporary exemptions. A vehicle manufacturer
wishing to obtain an exemption from a standard must demonstrate in its
application (A) That an exemption would be in the public interest and
consistent with the Safety Act and (B) that the manufacturer satisfies
one of the following four bases for an exemption: (i) Compliance with
the standard would cause substantial economic hardship to a
manufacturer that has tried to comply with the standard in good faith;
(ii) the exemption would make easier the development or field
evaluation of a new motor vehicle safety feature providing a safety
level at least equal to the safety level of the standard; (iii) the
exemption would make the development or field evaluation of a low-
emission motor vehicle easier and would not unreasonably lower the
safety level of that vehicle; or (iv) compliance with the standard
would prevent the manufacturer from selling a motor vehicle with an
overall safety level at least equal to the overall safety level of
nonexempt vehicles.
    For an exemption petition to be granted on the basis that the
exemption would make the development or field evaluation of a low-
emission motor vehicle easier and would not unreasonably lower the
safety level of the vehicle, the petition must include specified
information set forth at 49 CFR 555.6(c). The main requirements of that
section include: (1) Substantiation that the vehicle is a low-emission
vehicle; (2) documentation establishing that a temporary exemption
would not unreasonably degrade the safety of a vehicle; (3)
substantiation that a temporary exemption would facilitate the
development or field evaluation of the vehicle; (4) a statement of
whether the petitioner intends to conform to the standard at the end of
the exemption period; and (5) a statement that not more than 2,500
exempted vehicles will be sold in the United States in any 12-month
period for which an exemption may be granted.

II. Electronic Stability Control Systems Requirement

    In April 2007, NHTSA published a final rule requiring that vehicles
with a gross vehicle weight rating of 4,536 kilograms (kg) (10,000
pounds) or less be equipped with electronic stability control (ESC)
systems. ESC systems use automatic computer-controlled braking of
individual wheels to assist the driver in maintaining control in
critical driving situations in which the vehicle is beginning to lose
directional stability at the rear wheels (spin out) or directional
control at the front wheels (plow out). An anti-lock brake system (ABS)
is a prerequisite for an ESC system because ESC uses many of the same
components as ABS. Thus, the cost of complying with FMVSS No. 126 is
less for vehicle models already equipped with ABS.
    Preventing single-vehicle loss-of-control crashes is the most
effective way to reduce deaths resulting from rollover crashes. This is
because most loss-of-control crashes culminate in the vehicle leaving
the roadway, which dramatically increases the probability of a
rollover. NHTSA's crash data study of existing vehicles equipped with
ESC demonstrated that these systems reduce fatal single-vehicle crashes
of passenger cars by 55 percent and fatal single-vehicle crashes of
light trucks and vans (LTVs) by 50 percent.\1\ NHTSA estimates that ESC
has the potential to prevent 56 percent of the fatal passenger car
rollovers and 74 percent of the fatal LTV first-event rollovers that
would otherwise occur in single-vehicle crashes.\2\
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    \1\ Sivinski, R., Crash Prevention Effectiveness of Light-
Vehicle Electronic Stability Control: An Update of the 2007 NHTSA
Evaluation; DOT HS 811 486 (June 2011).
    \2\ Id.
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    The ESC requirement became effective for substantially all vehicles
on September 1, 2011.

III. Overview of Petition

    In accordance with 49 U.S.C. 30113 and the procedures in 49 CFR
Part 555, Tesla Motors, Inc. (Tesla) submitted a petition dated June 7,
2011 asking the agency for a temporary exemption from the electronic
stability control requirements of FMVSS No. 126. The bases for the
application are, first, that the exemption would make the development
or field evaluation of a low-emission vehicle easier and would not
unreasonably lower the safety level of that vehicle and, second, that
compliance would cause substantial economic hardship to a petitioner
that has tried in good faith to comply with the standard. However, the
agency has decided to grant the petition on the basis that an exemption
would make the development or field evaluation of a low-emission
vehicle easier and would not unreasonably lower the safety level of the
vehicle. Accordingly, this document will not further discuss the
portions of the petition related to only the economic hardship
arguments.
    Tesla has requested an exemption for the Roadster model for a
period from September 1, 2011 to December 31, 2011. In a supplemental
filing, Tesla stated that it now intends to manufacture no more than 80
vehicles under the requested exemption and that manufacturing would be
complete by October 20, 2011.
    Tesla is a Delaware corporation headquartered in California with
sales offices throughout the United States and overseas. Although Tesla
currently sells

only one vehicle, the Roadster, Tesla is scheduled to begin production
and sale of a new all-electric vehicle, the Model S, in 2012. Tesla is
also developing electric vehicle power train solutions for the Toyota
Motor Corporation RAV 4 sport utility vehicle and the Daimler AG
Mercedes A Class electric vehicle.
    Tesla began production of the all-electric Roadster in 2008. The
Roadster has a single-speed electrically actuated automatic
transmission and three phase, four pole AC induction motor. The
Roadster has a combined range of 245 miles on a single charge. Under an
agreement with Group Lotus plc (Lotus), Tesla purchases the Roadster
``glider,'' which uses the chassis and several other systems of the
Lotus Elise. The gliders are manufactured under Tesla's supervision and
direction at a Lotus factory in the United Kingdom and then shipped to
Menlo Park, California, where installation of the power train and other
final steps are taken prior to sale of the vehicle in the United
States.
    According to Tesla, the Roadster was conceived as a limited proof-
of-concept vehicle for later generations of Tesla vehicles. Tesla is
preparing to introduce its next electric vehicle, the four-door fully
electric Model S sedan. Tesla states that the Model S will meet or
exceed all FMVSSs in effect when the vehicle is released for production
in 2012. The Model S will carry up to seven passengers for 300 miles on
a single charge, but at less than half the price of the Tesla Roadster.
In parallel with the development of the Model S, Tesla is developing
electric power trains for two other vehicles intended for wide
distribution--the Toyota RAV 4 and Mercedes A Class electric vehicles.
For these reasons, Tesla asserts that granting the exemption will
support the development and evaluation of electric vehicles by Toyota
and Mercedes, as well as by Tesla itself.
    Tesla explains in its petition how the continued sale of Roadster
vehicles will support development and field evaluation of a highway-
capable electric vehicle. Tesla states that the development and sale of
the Roadster model has allowed it to develop its next all-electric
vehicle, the Model S. Tesla states that, with the permission of vehicle
owners, it has used data from computers installed in on-road Roadsters
related to vehicle operation, operating conditions, charging
conditions, state of charge, and other vehicle performance parameters
to determine how best to optimize its battery design and vehicle
software for future vehicle offerings such as the Model S. Tesla
believes that allowing the sale of additional Roadsters will continue
to enrich and add to its database of information for future electric
vehicle development. Tesla states that it cannot replicate this data in
laboratory or other non-highway conditions. Tesla contends that the
database from Roadster vehicles is the most substantial real-world
database available to government agencies such as NHTSA that are
involved in the evaluation of electric vehicles. Tesla also contends
that the 80 additional Roadster vehicles covered by its exemption
request have the most up-to-date software, hardware, controls and power
electronics of any Tesla vehicles, and that their operation therefore
will generate particularly valuable additional data that is most
valuable addition to the Tesla database. Because these Roadsters
incorporate the latest generation of technology and apply the most up-
to-date knowledge developed by Tesla, the company also asserts that
they are the most valuable vehicles for the development and release of
Tesla's next electric vehicle, the Model S.
    Tesla believes that safety will not be unduly compromised if the
exemption is granted. In support of this assertion, Tesla cites its
inclusion of a traction control system (TCS) on its vehicles. Tesla's
TCS is comprised of software, wheel speed sensors, and the drive system
electronic control unit (ECU). Tesla states that its TCS has many
elements of an ESC system required by FMVSS No. 126. Tesla claims that
the TCS is able to detect slip in the drive wheels through the
vehicle's ECU and that the vehicle will limit drive power until wheel
spin is controlled. However, Tesla notes that the TCS does not have the
capability to independently monitor or adjust steering inputs to
prevent oversteer or understeer, nor is it capable of applying brakes
independent of driver input, both of which are required by FMVSS No.
126.
    Further, Tesla believes that the lack of ESC systems on the
Roadster will not unduly compromise safety based on the intended use of
the Roadster. The Roadster is a low, two-seat sport coupe. Tesla
believes that, while the Roadster is capable of handling slippery roads
due to ice and snow, most owners either do not use their Roadsters
during winter months or sharply limit their use.
    Tesla contends that denial of its petition will jeopardize Tesla's
ability to make the transition to production of the Model S and other
electric vehicles. Tesla states that it currently employs approximately
1,100 people, primarily in Palo Alto and Fremont, California. Tesla had
intended its manufacturing and production line workers to complete
manufacture of the remaining Roadsters and then so shift their duties
over to the Model S. Tesla asserts that it is not yet ready to transfer
many Roadster manufacturing employees to the production operations for
the Model S, and that it therefore cannot support Roadster
manufacturing employees for the final quarter of 2011. Without the
additional 80 vehicles covered by its exemption request, Tesla's
production and manufacturing would have a significant gap in production
time lines. As a result, Tesla may be forced to lay off a significant
number of employees if it is not granted an exemption. Further, because
the Roadster is the only vehicle Tesla offers for sale in the United
States, Tesla contends that the cancellation of the program would
result in a significant loss of market for Tesla.
    In its petition, Tesla asserts that the continued sale of a high-
profile vehicle like the Roadster will make the U.S. public familiar
with the new possibilities of electric vehicles. The Roadster was
intended to demonstrate that electric vehicles can provide all the
performance, range and capabilities of internal combustion engine
vehicles, but without any emissions. Tesla contends that continued
production of the Roadster will help to ensure that the public remains
aware of the viability and practicality of high performance, long range
electric vehicles, as it makes the transition to the Model S.
    Tesla also believes that the exemption is in the public interest.
As stated above, Tesla asserts that, without the exemption, it may be
required to lay off a significant number of employees. Further, Tesla
notes that denying this petition would result in fewer electric
vehicles for sale in the United States. Tesla points out that, on the
basis of each mile driven, vehicles like the Roadster that operate only
on electricity have the greatest impact on reducing U.S. dependence on
foreign oil. As Tesla states in its petition, electric vehicles are not
just low-emission vehicles that would qualify for this exemption, but
zero emission vehicles. Finally, Tesla believes that continuing to sell
a long range, highway-capable, battery-powered electric vehicle in the
United States will lead to more electric vehicles entering the fleet.

IV. Notice of Receipt

    On August 5, 2011, we published in the Federal Register (76 FR
47639) a notice of receipt of Tesla's petition for temporary exemption,
and provided an opportunity for public comment. We received one comment
from the Advocates for Highway & Auto Safety (Advocates).

V. Agency Analysis, Response to Comment, and Decision

    In this section, we provide our analysis and decision regarding
Tesla's temporary exemption request concerning the ESC requirements of
FMVSS No. 126, including our response to the comment received by the
Advocates.
    As discussed below, we are granting Tesla's petition for the
Roadster to be exempted, for a period of 40 days after the date of
publication of this notice in the Federal Register, from the
requirements of FMVSS No. 126. The agency's rationale for this decision
is as follows:
    First, we conclude that Tesla has shown that an exemption from the
ESC requirements would make the development or field evaluation of a
low-emission motor vehicle easier. Specifically, we agree with Tesla
that, by producing additional Roadster models, Tesla will be able to
use data from computers installed on those vehicles to assist it in
optimizing its battery design and vehicle software for future all-
electric vehicle offerings, including its upcoming Model S, as well as
vehicles produced by other manufacturers working with Tesla.
Furthermore, Tesla's willingness to share data from its Roadster
database with NHTSA and other federal agencies means that the
additional data from the operation of these additional Roadsters will
help to advance the development, and to ensure the safety, of other
electric vehicles. We believe that the data from the Roadster database
can be used to ensure the safety of not only Tesla's future vehicles,
but also electric vehicles produced by all other manufacturers.
    Further, the production of additional Roadster models would allow
consumers of all-electric vehicles an additional option during the
exemption period. We agree with Tesla that continued production of a
high-profile vehicle like the Roadster, even for the very limited
period of 40 days and in the limited quantity of 80 vehicles, will help
to demonstrate to the U.S. public the performance, range and
capabilities of electric vehicles. We also agree with Tesla that
continued production of the Roadster for the limited period requested
by Tesla will ease Tesla's transition to the development and production
of the all-electric Model S. For that reason we agree that denial of
the petition could jeopardize Tesla's ability to produce the Model S
and other electric vehicles in the future. For these reasons, we agree
with Tesla that granting this petition will encourage the development
and sale of highway-capable electric vehicles by Tesla and also by
other manufacturers.
    Second, NHTSA concludes that the grant of this exemption would not
unreasonably lower the safety or impact protection level of the
vehicle. In particular, we have considered that Tesla produces a low,
two-seat sport vehicle. The low center of gravity provides some
additional protection from loss-of-control crashes. Furthermore, the
nature of the vehicle is such that we agree with Tesla's assertion that
Roadster owners would be less likely to use their vehicles in winter
months or during rain. Because the Roadster would be used less during
winter months or during rain, a Roadster is likely to be driven fewer
miles compared to an average vehicle. We believe that this factor
diminishes the likelihood that the failure to include an ESC system on
the Roadster would unreasonably lower the safety level of the vehicle.
    The Advocates argue that ESC is an important and proven safety
improvement. In support of their argument, the Advocates cite agency
and industry research, including the agency's most recent study of ESC
system effectiveness.\3\ While the agency continues to believe that ESC
has a substantial effect on the number of vehicle crashes, the relevant
inquiry is not the effectiveness of ESC systems. Rather, the relevant
inquiry is whether an exemption would unreasonably lower the safety
level of the vehicle in question. Although the agency has found
substantial benefits resulting from ESC systems on passenger cars, the
agency finds that the absence of ESC on the Roadster does not
unreasonably lower the safety level of that specific vehicle. We
believe that the expected use patterns of the Roadster, including the
relatively low number of miles driven by the average Roadster owner,
support this finding.
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    \3\ See supra, note 1.
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    The Advocates also argue that Tesla cannot guarantee the conditions
under which the vehicle will be used. That is, although Tesla argues
that Roadsters are less likely to be driven in winter months or during
rain, Tesla cannot guarantee that. However, we believe that the
Advocates would hold Tesla to too high of a burden of proof that would
essentially foreclose the possibility of any exemption being granted.
Moreover, although Tesla has not provided data in support of its
assertions, we find Tesla's assertions that a low, soft-top convertible
vehicle is less likely to be driven in the rain, snow, or winter months
to be plausible and persuasive.
    The Advocates also argue that Tesla's limited production of
exempted vehicles does not justify an exemption. The Advocates argue
that rarer vehicles are not safer just because they are rarer. While
the agency cannot dispute the assertion that rarer vehicles are not
safer because they are rarer, it does not follow that the agency should
not consider the expected production volume in support of an exemption
request. If Tesla intended to produce 2,500 vehicles per year over two
years rather than 80 vehicles in a little over a month, the agency
would judge Tesla's petition differently than the petition now before
it.
    Moreover, it is not just the limited number of Roadsters that would
be produced under the exemption, but the limited number of miles the
average Roadster is driven compared to other cars that Tesla cites in
support of its petition. The Advocates do not dispute the relatively
small number of vehicles that Tesla intends to produce under the
exemption and the relatively low-mileage use of the Roadster when
compared to other vehicles.
    The Advocates also contend that, because an FMVSS establishes only
the minimum performance requirements necessary for occupant protection,
an exemption must only be granted when absolutely necessary. However,
the statutory requirements for granting an exemption require only a
finding that an exemption is in the public interest and meets the
objectives of the Safety Act, in addition to the specific requirements
set forth for each of the four bases for an exemption.
    We also observe that a very limited number of vehicles would be
produced under this temporary exemption. Manufacturers granted
exemptions on the basis of furthering the development or field
evaluation of a low-emission vehicle are allowed to sell as many as
2,500 exempted vehicles in any 12-month period. Tesla has stated that
it intends to produce only 80 vehicles during the exemption period.
    The Advocates express a concern that Tesla has, in this petition,
requested a shorter exemption period than in its request for an
exemption from the advanced air bag requirements of FMVSS No. 208. The
Advocates suggest that the longer exemption period sought in the
advanced air bag exemption petition suggests that Tesla may continue
Roadster production beyond the date sought for this exemption. We
reject this argument as a basis for denying Tesla's petition. We give
greater weight to Tesla's most recent statement

that it intends to end Roaster production within less than 50 days of
the grant of this exemption than to any prior statements regarding its
production plans made in the context of prior submissions to the
agency.\4\
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    \4\ Furthermore, the effect of Tesla expressing different
production plans in its submissions related to this petition than in
its submissions on the advanced air bag petition are better
addressed in the context of the agency's response to the advanced
air bag petition because Tesla sought a longer exemption from the
advanced air bag requirements.
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    Based on the foregoing, we believe that any impact on safety from
granting the petition would be negligible and that Tesla has satisfied
the eligibility criteria for an exemption for the development or field
evaluation of a low-emission motor vehicle.
    The Advocates raise other issues in their comments that the agency
need not address in detail. Specifically, the Advocates argue that
Tesla had ample time to develop an FMVSS No. 126-compliant ESC system
because the final rule mandating ESC systems was published in the same
year that Roadster production first began. The Advocates also state
that the cost of including an ESC system is small relative to the cost
of the Roadster.\5\ The Advocates further argue that the loss of income
from sales of Roadsters that Tesla did not intend to produce cannot be
considered an economic hardship. Each of these comments relate to
requirements for economic hardship petitions. Because the agency has
determined that Tesla's exemption is justified under a different basis,
the agency need not address these three issues specifically in this
notice.
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    \5\ The agency does take note, however, that the cost of
implementing design modifications to the Roadster to accommodate ESC
would not be trivial.
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    We also find that this exemption would be consistent with the
public interest and the objectives of the Safety Act. NHTSA has
traditionally found that the public interest is served by affording
consumers a wider variety of motor vehicles, by encouraging the
development of fuel-efficient and alternative-energy vehicles, and
providing additional employment opportunities. We believe that all
three of these public interest considerations would be served by
granting Tesla's petition.
    We note that the denial of this request would remove one of the few
electric vehicles that is currently being sold in the U.S. market and
that granting this petition would afford U.S. consumers the continued
choice of this all-electric vehicle. As explained above, granting this
petition will ease the development of the Model S as well as other
electric vehicles, while conversely denial of the petition could
compromise Tesla's ability to move forward with the Model S. We believe
that granting this petition will have a positive impact on U.S.
employment in the automotive industry, and that denial of the petition
could directly impact the jobs of current Tesla employees supporting
the Roadster.
    Additionally, we believe that the requested exemption will have a
limited impact on general motor vehicle safety because of the small
number of vehicles that can be produced under this exemption. Finally,
it is critical to the agency's decision that Tesla is requesting a very
short exemption period and intends to sell only vehicles that comply
with all applicable FMVSS after the exemption period.
    We note that, as explained below, prospective purchasers will be
notified that the vehicle is exempted from the ESC requirements of
Standard No. 126. Under Sec.  555.9(b), a manufacturer of an exempted
vehicle must affix securely to the windshield or side window of each
exempted vehicle a label containing a statement that the vehicle
conforms to all applicable FMVSSs in effect on the date of manufacture
``except for Standard Nos. [listing the standards by number and title
for which an exemption has been granted] exempted pursuant to NHTSA
Exemption No. ----.'' This label notifies prospective purchasers about
the exemption and its subject. Under Sec.  555.9(c), this information
must also be included on the vehicle's certification label.\6\
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    \6\ Tesla's label would be required to list both its exemption
from FMVSS No. 126 and its exemption from the advanced air bag
requirements of FMVSS No. 208, which has been extended in a separate
decision that is published in today's Federal Register.
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    In consideration of the foregoing, we conclude that granting the
requested exemption from FMVSS No. 126, Electronic Stability Control
Systems, would facilitate the field evaluation or development of a low-
emission vehicle, and would not unreasonably lower the safety or impact
protection level of that vehicle. We further conclude that granting
this exemption would be in the public interest and consistent with the
objectives of the Safety Act.
    In accordance with 49 U.S.C. 30113(b)(3)(B)(iii), Tesla is granted
NHTSA Temporary Exemption No. EX 11-03 from FMVSS No. 126. The
exemption is for the Roadster model and shall remain effective from the
date on which notice of this decision is published in the Federal
Register for a period of 40 days, as indicated in the DATES section of
this document.

    Authority: (49 U.S.C. 30113; delegations of authority at 49 CFR
1.50. and 501.8)

    Issued on: September 22, 2011.
David L. Strickland,
Administrator.
[FR Doc. 2011-24899 Filed 9-27-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81562-81564]
[FR Doc No: 2015-32820]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76760; File No. SR-NASDAQ-2015-154]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Participant Fee

December 23, 2015.
    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 December 17, 2015, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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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 [sic] amend the Exchange's transaction fees
at Chapter XV, entitled ``Options Pricing,'' Section 10, entitled
``Participant Fee--Options.''
    The Exchange purposes [sic] an increase to its Participant Fee to
recoup costs incurred by the Exchange. The Exchange's Participant Fee
is competitive with those of other options exchanges.\3\ While the
amendment proposed herein is effective upon filing, the Exchange has
designated the amendment [sic] become operative on January 4, 2016.
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    \3\ See note 14 below.
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    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to increase the NOM Participant Fee, so the
Exchange can allocate its costs to various options market participants.
Today, the Exchange assesses all NOM Participants a $500 per month
Participant Fee. This fee was initially assessed in 2012.\4\ The
Exchange proposes to increase this Participant Fee from $500 to $1,000
per month for all NOM Participants. The proposed Participant Fee is in
addition to the trading rights fee of $1,000 per month to be an
Exchange member.\5\
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    \4\ See Securities and Exchange Act Release No. 68502 (December
20, 2012), 77 FR 76572 (December 28, 2012) (SR-NASDAQ-2012-139).
    \5\ See Exchange Rule 7001.
---------------------------------------------------------------------------

    The Exchange believes this Participant Fee is competitive with fees
at other options exchanges.\6\
---------------------------------------------------------------------------

    \6\ See note 14 below.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \7\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act \8\ 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 or
system which the Exchange operates or controls, and is not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4) and (5).
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    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, for example, the Commission indicated that

market forces should generally determine the price of non-core market
data because national market system regulation ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \9\ Likewise,
in NetCoalition v. NYSE Arca, Inc.\10\ (``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.\11\ 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.'' \12\
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    \9\ Securities Exchange Act Release No. 51808 at 37499 (June 9,
2005) (``Regulation NMS Adopting Release'').
    \10\ NetCoalition v. NYSE Arca, Inc., 615 F.3d 525 (D.C. Cir.
2010).
    \11\ See NetCoalition, at 534.
    \12\ Id. at 537.
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    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'. . . .'' \13\ 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.
---------------------------------------------------------------------------

    \13\ Id. at 539 (quoting ArcaBook Order, 73 FR at 74782-74783).
---------------------------------------------------------------------------

    The Exchange's proposal to increase the NOM Participant Fee from
$500 to $1,000 per month is reasonable because the Exchange is seeking
to recoup costs related to membership administration. The proposed fee
is competitive with fees at other options exchanges.\14\
---------------------------------------------------------------------------

    \14\ See The Chicago Board Options Exchange, Incorporated's Fees
Schedule. Per month a Market Maker Trading Permit is $5,500, an SPX
Tier Appointment is $3,000, a VIX Tier Appointment is $2,000, and an
Electronic Access Permit is $1,600. See also the International
Securities Exchange LLC's Schedule of Fees. Per month an Electronic
Access Member is assessed $500.00 for membership and a market maker
is assessed from $2,000 to $4,000 per membership depending on the
type of market maker. See also C2 Options Exchange, Incorporated's
Fees Schedule. Per month, a market-maker is assessed a $5,000 permit
fee, an Electronic Access Permit is assessed a $1,000 permit fee.
See also NYSE Arca, Inc.'s Fee Schedule. Per month, a Clearing Firm
is assessed a $1,000 per month fee for the first Options Trading
Permit (``OTP'') and $250 thereafter, and a market maker is assessed
a permit based on the maximum number of OTPs held by an OTP Firm or
OTP Holder during a calendar month ranging from $1,000 to $6,000 a
month.
---------------------------------------------------------------------------

    The Exchange's proposal to increase the NOM Participant Fee from
$500 to $1,000 per month is equitable and not unfairly discriminatory
because the Participant Fee will be assessed uniformly to each NOM
Participant.

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. In terms of inter-market
competition, 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 and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to 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.
    In terms of intra-market competition, the Exchange's proposal to
increase the NOM Participant Fee from $500 to $1,000 per month does not
impose an undue burden on competition because the Exchange would
uniformly assess the same Participant Fee to each NOM Participant. If
the proposed amendment is unattractive to market participants, it is
likely that the Exchange will lose Participants. Accordingly, the
Exchange does not believe that the proposed changes will impair the
ability of members or competing order execution venues to maintain
their competitive standing in the financial markets.

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.\15\
---------------------------------------------------------------------------

    \15\ 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_ADDRESS>Please include
File Number SR-NASDAQ-2015-154 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2015-154. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,

Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. 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-2015-154, and should
be submitted on or before January 20, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-32820 Filed 12-29-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57311-57312]
[DOCID:fr30se05-122]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-3261-EM]

Texas; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, Emergency Preparedness and
Response Directorate, Department of Homeland Security.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Texas (FEMA-3261-EM), dated September 21,
2005, and related determinations.

EFFECTIVE DATE: September 21, 2005.

FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal
Emergency Management Agency, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated

September 21, 2005, the President declared an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Texas, resulting from Hurricane Rita beginning on
September 20, 2005, and continuing, are of sufficient severity and
magnitude to warrant an emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121-5206 (Stafford Act). Therefore, I declare that such an
emergency exists in the State of Texas.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act to save lives, protect public health and safety, and
property or to lessen or avert the threat of a catastrophe in the
designated areas. Specifically, you are authorized to provide
emergency protective measures, (Category B), including direct
Federal assistance, under the Public Assistance program. This
assistance excludes regular time costs for subgrantees' regular
employees. In addition, you are authorized to provide such other
forms of assistance under Title V of the Stafford Act as you may
deem appropriate.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. For a period of up to 72 hours, you are authorized
to provide assistance for emergency protective measures, including
direct Federal assistance at 100 percent Federal funding of the
total eligible costs.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Acting Under Secretary for
Emergency Preparedness and Response, Department of Homeland Security,
under Executive Order 12148, as amended, Alexander S. Wells, of FEMA is
appointed to act as the Federal Coordinating Officer for this declared
emergency.
    I do hereby determine the following areas of the State of Texas to
have been affected adversely by this declared emergency:

    All 254 counties in the State of Texas for Public Assistance
Category B (emergency protective measures), including direct Federal
assistance, at 75 percent Federal funding of the total eligible
costs.
    For a period of up to 72 hours, assistance for emergency
protective measures, including direct Federal assistance, will be
provided at 100 percent Federal funding of the total eligible costs.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services Program; 97.034,
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and Households Housing; 97.049,
Individuals and Households Disaster Housing Operations; 97.050,
Individuals and Households Program--Other Needs; 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation Grant Program.)
R. David Paulison,
Acting Under Secretary, Emergency Preparedness and Response, Department
of Homeland Security.
[FR Doc. 05-19630 Filed 9-29-05; 8:45 am]

BILLING CODE 9110-10-P


(Ref. 20) and “Guidance for Industry:  Container Closure Systems for Packaging Human
Drugs and Biologics, Questions and Answers” (Ref. 21).
D.
Environmental Impact
Under 21 CFR 312.23(a)(7)(iv)(e), you must submit either a claim for categorical
exclusion under 21 CFR 25.30 or 25.31, or an environmental assessment under 21 CFR
25.40.  Such categorical exclusion is ordinarily granted, absent extraordinary
circumstances indicating that the specific proposed action might significantly affect the
quality of the human environment.  Extraordinary circumstances are described in 40 CFR
1508.27 and may include actions that create a potential for serious harm to the
environment and actions that adversely affect a species or the critical habitat of a species
determined to be endangered, threatened, or entitled to special protection (21 CFR
25.21).  See the “Guidance for Industry:  Environmental Assessment of Human Drug and
Biologics Applications” (Ref. 22) for additional information.
Note to FDA Reviewers:  Document in your review whether the sponsor has claimed a
categorical exclusion or evaluate the sponsor’s assessment of any extraordinary
circumstances using this product.
E.
Qualification of the Manufacturing Process
The manufacturing process for gene therapy products entails the use of reagents and
source materials of differing complexity, variability and risk for introduction of
adventitious agents.  Qualification of reagents and source materials, as well as ensuring
that appropriate controls are in place for monitoring manufacturing consistency and
product quality, are key elements in ensuring that subjects receive a product that is
consistently safe, pure, and potent.  We recommend that, prior to production of clinical
lots and initiation of clinical studies, you establish and implement written procedures to
ensure proper manufacturing oversight.  This includes the responsibilities and procedures
applicable to the quality control unit.  We recommend that you establish a quality control
(QC) plan and document that plan in writing.  For example, a sound QC plan must
provide for the following functions:
x
Responsibility for examining the various components used in the production of a
product (e.g., containers, closures, in-process materials) to ensure that they are
appropriate and meet defined, relevant quality standards (21 CFR 211.84(a));
27

Contains Nonbinding Recommendations
x
Responsibility for review and approval of production procedures, testing
procedures and acceptance criteria (21 CFR 211.22(c));
x
Responsibility for releasing or rejecting each clinical batch based on a cumulative
review of completed production records and other relevant information (21 CFR
211.22(a), 21 CFR 211.165, 21 CFR 211.192); and
x
Responsibility for investigating and initiating corrective actions if unexpected
results or errors occur during production (21 CFR 211.22(a), 21 CFR 211.192).
You should summarize the QC plan that is in place to prevent, detect, and correct
deficiencies that may compromise product integrity or function, or that may lead to the
possible transmission of adventitious infectious agents.  We recommend that QC
responsibilities be performed independently from production responsibilities by
dedicated QC personnel who are familiar with QC principles.  You should conduct
internal audits at planned intervals to evaluate effective implementation of the quality
plan and to determine if processes and products meet established parameters.  You should
develop and document audit procedures to ensure that the planned audit schedule takes
into account the relative risk of the various QC activities, the results of previous audits
and corrective actions, and the need to audit the entire operation at least annually.
Note to FDA Reviewers:  Document that you have reviewed the summary of the QC
plan.  Note each individual who has authority over the QC unit and the individual’s
assigned duties.  Document the date of the most recent internal audits of the
manufacturing operations and those of contract manufacturers, vendors, or other parties.
You should describe the changeover procedures that are followed to ensure that no cross-
contamination occurs among ex vivo genetically modified cells intended for an individual
subject and other products stored or produced in the same facility.  You should describe
the use of PCR assays for detecting area clearance, cleaning and decontamination
reagents and segregation of activities, and the qualification of aseptic processing steps.
Because most ex vivo genetically modified cell therapy products are not subject to final
sterile filtration prior to infusion, you should manufacture these products under aseptic
conditions.  A media fill is an appropriate method to qualify that the process produces a
sterile product.  Refer to the “Guidance for Industry:  Sterile Drug Products Produced by
Aseptic Processing – Current Good Manufacturing Practice” (Ref. 23) for further
information.
Note to FDA Reviewers:  Obtain consultative reviews from the Division of
Manufacturing and Product Quality, CBER, to assess any data submitted by the sponsor
on facilities and environmental issues such as decontamination and cleaning validation.
F.
Biostatistics
Note to FDA Reviewers:  Obtain consultative reviews for relevant portions of the CMC
section from the Division of Biostatistics to ensure the adequacy of proposed
experimental designs and analytic plans.  There are many significant design and analysis
issues in the areas of assay validation, establishing specifications, evaluation of product
28

Contains Nonbinding Recommendations
potency, and evaluation of product stability.  Proper statistical design and analysis of
such studies are essential to ensure reliable documentation of the safety, purity, and
potency of the product.  If applicable, document in your review recommendations from
the Biostatistics consult.
VIII.
PRECLINICAL STUDIES TO BE DOCUMENTED BY FDA REVIEWERS
A.
Summary of Concept Studies
Note to FDA Reviewers:  Document information provided by the sponsor to support the
scientific rationale underlying the proposal.  Include a brief summary of preclinical data
that was generated using in vivo animal studies and/or in vitro studies to assess the
product’s activity, efficacy, and any safety issues observed during the study.  Some issues
specific to gene therapy that should be documented include localization or trafficking of
vectors, and level and persistence of gene expression.
B.
Gonadal Distribution
Note to FDA Reviewers:  For gene therapy vectors used for direct in vivo administration,
work in consultation with the pharmacology/toxicology reviewer to document data that
demonstrate the extent to which a vector is able to disseminate out of the administration
site and distribute to the gonads.  In most cases, this information is not available at the
beginning of the Phase 1 study but would become available in the course of product
development.  Such data are usually obtained by using a PCR assay.  In cases where a
novel vector, route of administration, indication, or vector delivery system is proposed,
preclinical studies to assess vector dissemination may be appropriate prior to initiation of
the Phase 1 study.  Document in your review the sensitivity of this assay (amount
vector/
P
g cellular DNA), including assay controls (positive, negative and spiked
controls).  We believe that the PCR assay sensitivity should be less than 50 copies of
vector genome per
P
g cellular DNA.
IX.
CLINICAL STUDIES TO BE DOCUMENTED BY FDA REVIEWERS
Note to FDA Reviewers:  Provide a brief description of the following in the CMC review:
A.
Protocol Title
Name of the protocol.
B.
Subject Population
Define the population; e.g., size, gender, race, age, etc.
29

Contains Nonbinding Recommendations
C.
Route of Administration
Define; e.g., oral, intravenous, intramuscular, etc.
D.
Dose
Include the dosing regimen and whether there is a dose escalation.  Document the dosing
range and number of subjects enrolled in each dose.  Describe the plans for dose
escalation and what time interval/data evaluations occur between dose increases.
E.
Frequency
Include the frequency of dose injections per treatment cycle and the number of proposed
cycles.
F.
Genetic, Biochemical, and Immunological Testing
Assess, in conjunction with the clinical reviewer, whether all genetic and/or product-
specific biochemical and immunological testing of subjects is appropriate for the stage of
clinical investigation.  Evaluate the sensitivity and specificity of the test methods used to
demonstrate biological activity (e.g., immunological assay, PCR) and document this
information in your review.  In conjunction with the clinical reviewer, verify and
document that serum from a patient on a retroviral gene therapy protocol is analyzed for
the presence of RCR at 3, 6, and 12 months after treatment.  If all post-treatment assays
are negative during the first year, then yearly patient samples may be archived (Ref. 13).
G.
Informed Consent
If the informed consent document is submitted for your review, verify that the product is
described accurately and completely.
H.
Recombinant DNA Advisory Committee (RAC) Review
If the sponsor or the sponsor’s institution receives NIH funding for DNA recombinant
studies or if any clinical sites used in the study receive NIH funding for Recombinant DNA
studies, you should remind the sponsor that under the NIH Recombinant DNA Guidelines,
NIH will not allow the protocol to be initiated until the Recombinant DNA Advisory
Committee (RAC) review has occurred.  Confirm that the sponsor has submitted the
protocol to RAC for review.  For additional information refer to the “NIH Guidelines for
Research Involving Recombinant DNA Molecules” (Ref. 24).
X.
RECOMMENDATION TO BE DETERMINDED BY FDA REVIEWERS
Note to FDA Reviewers:  Describe any information that is missing or incomplete, and issues that
require additional clarification.  Provide an overall assessment from the CMC perspective of
30

Contains Nonbinding Recommendations
whether the trial may proceed or should be placed on clinical hold.  Document all information
obtained from the sponsor through telephone conversations or faxes.  Note this documentation in
the Recommendation Section of the Product Review Template, throughout the review document,
or as an attachment to the review, as appropriate.  Upon completion, sign and date the review
and then obtain concurrence from your supervisor.
XI.
COMMENTS TO SPONSOR GENERATED BY FDA REVIEWERS
Note to FDA Reviewers:  Draft letter comments on unresolved issues as discussed below.  Refer
to SOPP 8201, “Issuance of and Response to Clinical Hold Letters for Investigational New Drug
Applications” (Ref. 25), for additional information.  After you have obtained supervisory
concurrence on your review, forward your comments to the RPM for inclusion in a letter to the
sponsor.
A.
Clinical Hold
Clinical hold comments are comments that the sponsor must satisfactorily address prior
to allowing clinical studies to proceed after FDA has imposed a clinical hold.  These
comments must meet the criteria listed in 21 CFR 312.42(b).
B.
Non-Clinical Hold
Non-clinical hold comments are comments that the sponsor should address as product
development progresses.  In some cases, a sponsor may need to address specific
manufacturing issues by a certain point in clinical development, such as prior to initiation
of Phase 3 studies.
31

Contains Nonbinding Recommendations
XII.
REFERENCES
1.
Guidance for Industry:  Content and Format of Investigational New Drug Applications
(INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
Biotechnology-Derived Products, November 1995,
http://www.fda.gov/cder/guidance/phase1.pdf.
2.
Final Rule:  Eligibility Determination for Donors of Human Cells, Tissues, and Cellular
and Tissue-Based Products, (69 FR 29786, May 25, 2004),
http://www.fda.gov/cber/rules/suitdonor.pdf.
3.
Guidance for Industry:  Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps), August 2007,
http://www.fda.gov/cber/gdlns/tissdonor.pdf.
4.
Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals, July
12, 1993, http://www.fda.gov/cber/gdlns/ptccell.pdf.
5.
ICH Guidance on Quality of Biotechnological/Biological Products:  Derivation and
Characterization of Cell Substrates Used for Production of Biotechnological/Biological
Products, (63 FR 50244, September 21, 1998), http://www.fda.gov/cber/gdlns/qualbiot.pdf.
6.
Guidance for Industry:  Source Animal, Product, Preclinical and Clinical Issues
Concerning the Use of Xenotransplantation Products in Humans, April 2003,
http://www.fda.gov/cber/gdlns/clinxeno.htm.
7.
PHS Guideline on Infectious Disease Issues in Xenotransplantation, January 19, 2001,
http://www.fda.gov/cber/gdlns/xenophs0101.htm.
8.
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for
Human Use, February 28, 1997, http://www.fda.gov/cber/gdlns/ptc_mab.pdf.
9.
Manual of Standard Operating Procedures and Policies: Intercenter
Consultative/Collaborative Review Process, Version 4, dated June 18, 2004,
http://www.fda.gov/oc/ombudsman/intercentersop.pdf.
10.
FDA Guidance Concerning Demonstration of Comparability of Human Biological Product,
Including Therapeutic Biotechnology-derived Products, April 1996,
http://www.fda.gov/cber/gdlns/comptest.pdf.
11.
United States Pharmacopoeia (USP), Chapter <71> Sterility Tests, 23
rd
edition, 1995,
http://www.usp.org.
12.
ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell
Lines of Human or Animal Origin, (63 FR 51074, September 24, 1998),
http://www.fda.gov/cber/gdlns/virsafe.pdf.
32

Contains Nonbinding Recommendations
13.
Guidance for Industry:  Supplemental Guidance on Testing for Replication Competent
Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of
Patients in Clinical Trials Using Retroviral Vectors, dated October 2006,
http://www.fda.gov/cber/gdlns/retrogt1000.htm.
14.
ICH Topic Q3.  Impurities.
Guidance for Industry:  Q3A Impurities in New Drug Substances, February 2003,
http://www.fda.gov/cber/gdlns/ichq3a.pdf.
Guidance for Industry:  Q3B(R2) Impurities in New Drug Products, July 2006,
http://www.fda.gov/cber/gdlns/ichq3br.pdf.
Guidance for Industry:  Q3C Impurities: Residual Solvents, December 1997,
http://www.fda.gov/cber/gdlns/q3cresolvent.pdf.
15.
Guideline on Validation of the Limulus Amebocyte Lysate test as an End-Product
Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical
Devices, 1987, http://www.fda.gov/cber/gdlns/lal.pdf.
16.
Revisions to the General Safety Requirements for Biological Products, 68 FR 10157,
March 4, 2003.
17.
Guideline for Industry:  Quality of Biotechnological Products: Stability Testing of
Biotechnological/Biological Products, July 1996 (ICH Q5C),
http://www.fda.gov/cder/guidance/ichq5c.pdf.
18.
Guidance for Industry:  Q1A(R2): Stability Testing of New Drug Substances and Products
(Revision 2), November 2003, http://www.fda.gov/cber/gdlns/ichstab.pdf.
19.
Guidance for Industry:  Q1E:  Evaluation of Stability Data, June, 2004,
http://www.fda.gov/cber/gdlns/ichstabdta.pdf.
20.
Guidance for Industry:  Container Closure Systems for Packaging Human Drugs and
Biologics; Chemistry, Manufacturing, and Controls Documentation, May 1999,
http://www.fda.gov/cber/gdlns/cntanr.pdf.
21.
Guidance for Industry:  Container Closure Systems for Packaging Human Drugs and
Biologics, Questions and Answers, May 2002,
http://www.fda.gov/cber/gdlns/cntanrq&a.pdf.
22.
Guidance for Industry:  Environmental assessment of Human Drug and Biologics
Applications, Revision 1, July 1998, http://www.fda.gov/cber/gdlns/environ.pdf.
23.
Guidance for Industry:  Sterile Drug Products Produced by Aseptic Processing – Current
Good Manufacturing Practice, September 2004,
http://www.fda.gov/cber/gdlns/steraseptic.htm.
33

Contains Nonbinding Recommendations
24.
NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines),
April 2002, http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.
25.
Manual of Standard Operating Procedures and Policies Investigational New Drug; Issuance
of and Response to Clinical Hold Letters for Investigational New Drug Applications, SOPP
8201, Version #3, April 27, 1999, http://www.fda.gov/cber/regsopp/8201.htm.
34

Contains Nonbinding Recommendations
APPENDIX A – PRODUCT REVIEW TEMPLATE (GENE THERAPY)
PRODUCT REVIEW (GENE CELL)
Supervisor Concurrence/Date
IND:
XXXX
Sponsor’s Submission Date:
Month DD, YYYY
30 Day Review Due Date:
Month DD, YYYY
STATUS: Pending
DATE:
Month DD, YYYY
REVIEWER:
Your Name
Your Title, OCTGT/DCGT/Your Branch
THROUGH:
Branch Chief Name
Branch Chief, OCTGT/DCGT/Branch
SPONSOR:
Name:
Address:
Title:
Phone:
Fax:
SPONSOR POINT OF CONTACT:
Name:
Address:
Title:
Phone:
Fax:
TITLE OF IND:
PROPOSED USE:
REVIEW TEAM:
Clinical:
Pharm-Tox:
RPM:
Consults:
PRODUCT DESCRIPTION:
PHASE OF STUDY:
CROSS-REFERENCED INDS, IDES, MFS:
KEY WORDS:
INTRODUCTION / RATIONALE:
35

Contains Nonbinding Recommendations
STUDY OBJECTIVES:
PRODUCT MANUFACTURING AND CHARACTERIZATION:
Product Manufacturing - Components
Cells
Allogeneic or Autologous Cell Components
Cell Source:
Method of Collection:
Donor Screening:
Description
Tabulation of Testing
Cell Bank System - If Applicable
Master Cell Bank (MCB)
Description
Tabulation of Testing
Working Cell Bank (WCB)
Description
Tabulation of Testing
Reagents
Tabulation of Reagents Used in Manufacture
Reagent/Excipient
Concentration at use
Source
Grade
Vendor
COA
Qualification Program
Determination of Removal of Reagents from Final Product
Combination Products - If Applicable
Drug or Device Components - If Applicable
36

Contains Nonbinding Recommendations
Consult Review Issues:
Areas of Concern for Components:
Product Manufacturing - Procedures
Preparation of Autologous or Allogeneic Cells
Method of Cell Collection/Processing/Culture Conditions
Irradiation - If Applicable
Process Timing & Intermediate Storage
Final Harvest
Timing/Methods/Wash Procedure
Final Formulation
Formulation/Infusion Buffer
Excipients
Cell Density/Concentration in the Final Product
Storage Method Prior to Use
Areas of Concern for Manufacturing
PRODUCT TESTING
In-Process Testing and Criteria
Tabulation of Tests, Manufacturing Step, Test Methods, Criteria, and Test Sensitivity &
Specificity
37

Contains Nonbinding Recommendations
Test
Manufacturing
Step Where
Performed
Method
Criteria
Sensitivity
Specificity
Sterility
Mycoplasma
Purity
(endotoxin)


[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Notices]
[Pages 1597-1599]
[FR Doc No: 2023-00389]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1203]

Prescription Drug User Fee Act of 2023 VII Meetings Program for
Model-Informed Drug Development Approaches

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The seventh iteration of the Prescription Drug User Fee Act
(PDUFA VII), incorporated as part of the FDA User Fee Reauthorization
Act of 2022, highlights the goal of advancing model-informed drug
development (MIDD). The Food and Drug Administration (FDA or Agency) is
announcing the continuation of the MIDD Paired Meeting Program that
affords sponsors who are selected for participation the opportunity to
meet with Agency staff to discuss MIDD approaches in medical product
development. Meetings under the program will be conducted by FDA's
Center for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) during fiscal years 2023-2027. This
program is being conducted to fulfill FDA's performance commitment
under PDUFA VII. For this program, MIDD is defined as the application
of exposure-based, biological, and/or statistical models derived from
non-clinical and clinical data sources to address drug development and/
or regulatory issues (see Supplementary Information, I. Background, and
II. Eligibility and Selection for Participation of this notice). For
each approved proposal, the program consists of two meetings between
sponsors or applicants and the relevant center that provide an
opportunity for drug developers and FDA to discuss the application of
MIDD approaches to the development and regulatory evaluation of medical
products in development.

DATES: FDA will accept requests to participate in the program on a
continuous basis beginning on October

1, 2022, through June 1, 2027. See section III of this notice for
instructions about how to request participation in the program.
Meeting-granted and -denied decisions will be made the last 2 weeks of
each quarter of the fiscal year based on submissions received to date.
Requesters will receive a meeting-granted or -denied notification no
later than the second week of the new quarter.
    The program will proceed from October 1, 2022, through September
30, 2027. The Agency will notify sponsors of proposals not selected for
a given quarter. Sponsors who do not participate in the program may
seek Agency interaction through existing channels (e.g., Type C meeting
requests, critical path innovation meetings). The listed eligibility
criteria and procedures outlined in this Federal Register notice
reflect the current thinking at the time of publication. Processes may
be revised and will be communicated as this program evolves. The most
current program eligibility criteria and procedures may be found on the
MIDD Program website: https://www.fda.gov/drugs/development-resources/model-informed-drug-development-paired-meeting-program.

ADDRESSES: Comments about this program can be submitted until February
10, 2023. You may submit comments about the MIDD meetings program 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-1203 for ``Prescription Drug User Fee Act of 2023 VII
Meetings Program for Model-Informed Drug Development Approaches.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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 Dockets Management Staff. 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.govinfo.gov/content/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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:
    CDER: Yvonne Knight, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2142,
Silver Spring, MD 20993,<PHONE_NUMBER>, [email protected] with
the subject line ``MIDD Meetings Program for CDER.''
    CBER: Christopher Egelebo, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 5340, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected] with the subject line ``MIDD Meetings
Program for CBER.''

SUPPLEMENTARY INFORMATION:

I. Background

    Under the FDA User Fee Reauthorization Act of 2022, FDA agreed, in
accordance with the ``PDUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2023 Through 2027: I. Ensuring the
Effectiveness of the Human Drug Review, Part L. Enhancing Regulatory
Decision Tools to Support Drug Development and Review'' to provide
information on how a sponsor can apply to participate in the MIDD
Meetings Program (https://www.fda.gov/media/151712/download).
    FDA will build on the success of the MIDD Paired Meeting Pilot
under PDUFA VI by continuing to advance and integrate the development
and application of exposure-based, biological, and statistical models
derived from non-clinical and clinical data sources in drug development
and regulatory review. FDA is announcing the continuation of this
meeting program to satisfy the above-mentioned commitment and to
facilitate the continued use of MIDD approaches. These approaches
exclude statistical designs involving complex adaptations, Bayesian
methods, or other features requiring computer simulations to determine
the operating characteristics of a confirmatory clinical trial. MIDD
approaches use a variety of quantitative methods to help balance the
risks and benefits of drug products in development. When successfully
applied, MIDD approaches can improve clinical trial efficiency,
increase the probability of regulatory success, and optimize drug
dosing/therapeutic individualization in the absence of dedicated
trials.

    The goal of the early meeting discussions granted under this
program is to provide advice on how specific, proposed MIDD approaches
can be used in a particular drug development program. FDA has committed
to accepting one to two appropriate meeting requests quarterly each
fiscal year. The meetings granted will include an initial and followup
meeting on the same drug development issues. The second meeting will
occur within approximately 60 days of receiving the briefing package.

II. Eligibility and Selection for Participation in the MIDD Program

    The sponsor should be a drug/biologics development company
(interested consortia or software/device developer should come in
partnership with a drug development company) and have an
investigational new drug application (IND) or pre-IND (PIND) number for
the relevant program. FDA welcomes submissions related to any relevant
MIDD topics, such as:
     Dose selection or estimation (e.g., for dose/dosing
regimen selection or refinement)
     Clinical trial simulation (e.g., based on drug-trial-
disease models to inform the duration of a trial, select appropriate
response measures, predict outcomes, etc.)
     Predictive or mechanistic safety evaluation (e.g., use of
systems pharmacology/mechanistic models for predicting safety or
identifying critical biomarkers of interest)

III. Procedures and Submission Information

A. General Information

    The MIDD program will be jointly administered by CDER's Office of
Clinical Pharmacology, in the Office of Translational Sciences, which
is the point of contact for all communications for CDER products, and
CBER's Office of Biostatistics and Pharmacovigilance, which is the
point of contact for all communications for CBER products.

B. How To Submit a Meeting Request and Meeting Package

    Meeting requests should be submitted electronically to the relevant
application (i.e., PIND, IND) with ``MIDD Program Meeting Request for
CDER'' (CDER applications) or ``MIDD Program Meeting Request for CBER''
(CBER applications) in the subject line. Information about providing
regulatory submissions in electronic format is available at: https://www.fda.gov/drugs/development-approval-process-drugs/forms-submission-requirements.

C. Content and Format of the Meeting Request

    Include the following information in the meeting request (no more
than three to four pages):
    1. Product name.
    2. Application number.
    3. Chemical name and structure.
    4. Proposed indication(s) or context of product development.
    5. A brief statement of the purpose and objectives of the meeting.
The statement should include a brief background of the MIDD issues
underlying the agenda.
    6. MIDD approach(es) considered for the product under development
and how MIDD can assess uncertainties about issues (e.g., dosing,
duration, patient selection) in a way that can inform regulatory
decision-making.
    7. A list of issues for discussion with the Agency about the
specific MIDD proposed approach for the applicable drug development
program.

D. Content and Format of the Meeting Information Package

    Sponsors whose meeting requests are granted as part of the program
should submit a meeting information package electronically with ``MIDD
Program Meeting Package for CDER'' (CDER applications) or ``MIDD
Program Meeting Package for CBER'' (CBER applications) in the subject
line no later than 47 days before the initial meeting and 60 days
before the follow-up meeting. This meeting package should include the
following information:
    1. Product name.
    2. Application number.
    3. Chemical name and structure.
    4. Proposed indications or context of product development.
    5. Background section that includes a brief history of the
development program and the events leading up to the meeting as well as
the status of product development.
    6. Proposed agenda, including estimated times needed for discussion
of each agenda item.
    7. List of questions for discussion along with a brief summary
explaining the question of interest and the context of use for each
question. State whether the model will be used to inform future trials,
to provide mechanistic insight, or in lieu of a clinical trial.
    8. The drug development issue (e.g., dosing, clinical trial design,
safety prediction, etc.), the proposed MIDD approach to the solution,
information to support discussion (e.g., a description of the data
utilized for developing the models, model development, simulation plan,
results), assessment of model risk, and how the Agency can help guide
any next steps relative to the regulatory decision-making process
should be summarized and clearly articulated with any supporting data
imperative to the discussion.

E. Meeting Summaries

    A meeting summary will be sent to the requester within 30 days of
each meeting.

IV. Paperwork Reduction Act of 1995

    While this notice contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this notice. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information pertaining to Prescription Drug User Fee Program have
been approved under OMB control number 0910-0297. The collections of
information for requesting meetings with FDA about drug development
programs have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR part 312 for INDs and clinical
trials have been approved under OMB control number 0910-0014. The
collections of information in 21 CFR part 601 for biologics license
applications have been approved under OMB control number 0910-0338.

    Dated: January 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00389 Filed 1-10-23; 8:45 am]
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[Federal Register Volume 86, Number 15 (Tuesday, January 26, 2021)]
[Notices]
[Page 7168]
[FR Doc No: 2021-01641]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2020-78]

Petition for Exemption; Summary of Petition Received; California
Fire Pilots Association

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before February 16, 2021.

ADDRESSES: Send comments identified by docket number FAA-2020-1127
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Linda Lane,<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Timothy R. Adams,
Deputy Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2020-1127.
    Petitioner: California Fire Pilots Association.
    Section(s) of 14 CFR Affected: Sec.  61.51(j).
    Description of Relief Sought: California Fire Pilots Association
(CFPA) seeks an exemption from Sec.  61.51(j), of Title 14, Code of
Federal Regulations (14 CFR) to the extent necessary to allow CFPA's
pilots to log flight time while flying California Department of
Forestry and Fire Protection agency public aircraft. Current
regulations for logging flight time in a public aircraft under the
direct operational control of Federal, State, county, or municipal law
enforcement agency is limited to operations where the pilot is engaged
on an official law enforcement flight. Additionally, CFPA seeks to have
the exemption, if granted, remain in effect until the Administrator
completes the modification of Sec.  61.51(j) as required by Section 517
of the FAA Reauthorization Act of 2018 (Pub. L. 115-254).

[FR Doc. 2021-01641 Filed 1-25-21; 8:45 am]
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[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57183]
[FR Doc No: 2021-22395]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4525-DR; Docket ID FEMA-2021-0001]

Utah; Amendment No. 5 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Utah (FEMA-4525-DR), dated April 4, 2020, and related
determinations.

DATES: This change occurred on July 6, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Tammy L.
Littrell, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Nancy J. Dragani as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22395 Filed 10-13-21; 8:45 am]
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