[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Rules and Regulations]
[Pages 60676-60679]
[FR Doc No: 2013-24031]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0090; Directorate Identifier 2012-NM-149-AD;
Amendment 39-17595; AD 2013-19-13]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B,
747-200C, 747-300, 747-400, 747-400D, and 747SP series airplanes. This
AD was prompted by reports of worn or incorrectly assembled latches on
main deck escape slides installed on airplane doors. This AD requires
determining if the latches are correctly assembled; and doing
corrective actions if necessary. This AD also requires, for certain
airplanes, modifications to the escape slide/rafts and escape slides.
We are issuing this AD to prevent a latch hook moving from closed to
open in an escape slide/raft or escape slide, which could result in the
escape slide/raft or escape slide not deploying correctly in an
emergency, or releasing/inflating into the passenger cabin and causing
injury to passengers and crew.

DATES: This AD is effective November 6, 2013.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 6,
2013.

ADDRESSES: For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. For Goodrich service information identified in
this AD, contact Goodrich Corporation, Aircraft Interior Products,
ATTN: Technical Publications, 3414 South Fifth Street, Phoenix, AZ
85040-1169; telephone<PHONE_NUMBER>; Internet http://www.goodrich.com/TechPubs. You may review copies of the referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sarah Piccola, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to the specified products. The
NPRM published in the Federal Register on February 8, 2013 (78 FR
9346). The NPRM proposed to require determining if the latches on main
deck escape slides installed on airplane doors are correctly assembled;
and doing corrective actions if necessary. The NPRM also proposed to
require, for certain airplanes, modifications to the escape slide/rafts
and escape slides.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(78 FR 9346, February 8, 2013) and the FAA's response to each comment.

Request To Extend Compliance Time

    Delta Air Lines (DAL) requested that the compliance time in the
NPRM (78 FR 9346, February 8, 2013) be extended to 60 months. DAL
stated that this will

allow for the modification to be accomplished at the next scheduled
overhaul for DAL's affected slides.
    We disagree with DAL's request to extend the compliance time. In
developing an appropriate compliance time for this action, we
considered the safety implications, parts availability, and normal
maintenance schedules for the timely accomplishment of the inspections
and modification. However, under the provisions of paragraph (j) of
this final rule, we will consider requests for approval of an extension
of the compliance time if sufficient data are submitted to substantiate
that the new compliance time would provide an acceptable level of
safety. We have not changed this final rule in this regard.

Requests To Refer to Revised Service Information

    United Airlines and Boeing stated that Boeing has issued revised
service information. The commenters requested that the service
information in the NPRM (78 FR 9346, February 8, 2013) be updated to
refer to Boeing Special Attention Service Bulletin 747-25-3428,
Revision 4, dated February 25, 2013.
    DAL requested that the NPRM (78 FR 9346, February 8, 2013) be
revised to allow the replacement of affected slides with slides on
which the inspection and modification have been done in accordance with
the Accomplishment Instructions of Boeing Special Attention Service
Bulletin 747-25-3428, Revision 3, dated June 14, 2012.
    We agree with United Airlines' and Boeing's requests and have
revised paragraphs (c), (g), and (h) in this final rule to refer to
Boeing Special Attention Service Bulletin 747-25-3428, Revision 4,
dated February 25, 2013.
    We also agree with DAL's request and have revised paragraph (i) of
this final rule by redesignating paragraph (i) of the NPRM (78 FR 9346,
February 8, 2013) as paragraph (i)(2), and adding new paragraph (i)(1),
which provides credit for the applicable actions required by paragraph
(g) of this final rule, if those actions were performed before the
effective date of this final rule using Boeing Special Attention
Service Bulletin 747-25-3428, Revision 3, dated June 14, 2012.

Request To Allow Replacement of Slides Using a Means Other Than the
Service Information

    DAL requested that, alternatively, the proposed AD (78 FR 9346,
February 8, 2013) be revised to include a statement that accomplishment
of the inspection and modification by means of an approved routine
maintenance item would be acceptable.
    As previously stated, we deem it acceptable to replace an affected
part with a part that has been inspected and modified in accordance
with the Accomplishment Instructions of Boeing Special Attention
Service Bulletin 747-25-3428, Revision 3, dated June 14, 2012.
    Regarding the use of an approved maintenance item instead of the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 747-25-3428, Revision 3, dated June 14, 2012, DAL included
this as a conditional statement if the slide replacement discussed
above was deemed unacceptable. As stated above, we agree that affected
slides can be replaced with slides that have completed the inspection
and modification in accordance with the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 747-25-3428, Revision 3,
dated June 14, 2012. However, once this final rule is issued, any
person may request approval of an AMOC under the provisions of
paragraph (j) of this final rule. We have not changed this final rule
in this regard.

Additional Change to This Final Rule

    We added Note 1 to paragraph (g) of this final rule to reference
additional guidance material.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously--and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 9346, February 8, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 9346, February 8, 2013).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 121 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on  U.S.
             Action                    Labor cost            Parts cost      Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Determine if latches are         1 work-hour x $85 per   $0...............  $85..............  $10,285.
 correctly assembled.             hour = $85.
Option to rework/replace         Between 3 and 24 work-  $286 per latch...  Between $541 and   Between $65,461
 latches instead of determining   hours x $85 per hour                       $2,326.            and $281,446.
 if latches are correctly         = Between $255 and
 assembled.                       $2,040.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the latch assembly
determination. We have no way of determining the number of aircraft
that might need this replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
               Action                         Labor cost                Parts cost           Cost per product
----------------------------------------------------------------------------------------------------------------
Corrective action..................  Between 3 and 24 work-hours  $286 per latch........  Between $541 and
                                      x $85 per hour = Between                             $2,326.
                                      $255 and $2,040.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, all of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 adding the following new airworthiness
directive (AD):

2013-19-13 The Boeing Company: Amendment 39-17595; Docket No. FAA-
2013-0090; Directorate Identifier 2012-NM-149-AD.

(a) Effective Date

    This AD is effective November 6, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 747-100, 747-100B,
747-100B SUD, 747-200B, 747-200C, 747-300, 747-400, 747-400D, and
747SP series airplanes; certificated in any category; as identified
in Boeing Special Attention Service Bulletin 747-25-3428, Revision
4, dated February 25, 2013; except for Groups 3-4, Configuration 2,
and Group 9, Configuration 2, airplanes.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 25, Equipment/furnishings.

(e) Unsafe Condition

    This AD was prompted by reports of worn or incorrectly assembled
latches on main deck escape slides installed on airplane doors. We
are issuing this AD to prevent a latch hook moving from closed to
open in an escape slide/raft or escape slide, which could result in
the escape slide/raft or escape slide not deploying correctly in an
emergency, or releasing/inflating into the passenger cabin and
causing injury to passengers and crew.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Replacement or Rework of Escape Slide Latch Assembly

    Within 48 months after the effective date of this AD: Determine
if the latches in the main deck escape slide/rafts and the escape
slides installed on the airplane doors are correctly assembled, and
do all applicable corrective actions, in accordance with the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 747-25-3428, Revision 4, dated February 25, 2013. Do all
applicable corrective actions before further flight. Options
provided in Boeing Special Attention Service Bulletin 747-25-3428,
Revision 4, dated February 25, 2013, for determining the correct
assembly of the latches are acceptable for the corresponding
requirement of this paragraph.

    Note 1 to paragraph (g) of this AD: Boeing Special Attention
Service Bulletin 747-25-3428, Revision 4, dated February 25, 2013,
refers to Goodrich Service Bulletin 25-367, Revision 1, dated May 1,
2012, as an additional source of guidance for unpacking the escape
slide/raft assemblies.

(h) Concurrent Requirements

    For Groups 1, 5, 10, and 13 airplanes, as identified in Boeing
Special Attention Service Bulletin 747-25-3428, Revision 4, dated
February 25, 2013: Prior to or concurrently with accomplishing the
actions required by paragraph (g) of this AD, replace the packboard
cap nuts with flush-type inserts, reinforce the lower packboard
support bracket attachments, install hooks, modify the lower liner
of the main entry door and packboard, and remove the ``Press to
Test'' circuit panel and associated circuitry, in accordance with
the Accomplishment Instructions of Boeing Service Bulletin 747-25-
2425, Revision 1, dated September 7, 1979.

(i) Credit for Previous Actions

    (1) This paragraph provides credit for the applicable actions
required by paragraph (g) of this AD, if those actions were
performed before the effective date of this AD using Boeing Special
Attention Service Bulletin 747-25-3428, Revision 3, dated June 14,
2012, which is not incorporated by reference in this AD.
    (2) This paragraph provides credit for the applicable concurrent
actions required by paragraph (h) of this AD, if those actions were
performed before the effective date of this AD using Boeing Service
Bulletin 747-25-2425, dated August 25, 1978, which is not
incorporated by reference in this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO)
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(k) Related Information

    (1) For more information about this AD, contact Sarah Piccola,
Aerospace Engineer, Cabin Safety and Environmental Systems

Branch, ANM-150S, FAA, Seattle Aircraft Certification Office, 1601
Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:
425-917-6590; email<EMAIL_ADDRESS>    (2) For Goodrich service information identified in this AD,
contact Goodrich Corporation, Aircraft Interior Products, ATTN:
Technical Publications, 3414 South Fifth Street, Phoenix, AZ 85040-
1169; telephone<PHONE_NUMBER>; Internet http://www.goodrich.com/TechPubs.
    (3) Boeing service information identified in this AD that is not
incorporated by reference may be obtained at the addresses specified
in paragraphs (l)(3) and (l)(4) of this AD.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Special Attention Service Bulletin 747-25-3428,
Revision 4, dated February 25, 2013.
    (ii) Boeing Service Bulletin 747-25-2425, Revision 1, dated
September 7, 1979. (Pages 1 through 4 of this document are dated
September 7, 1979. Pages 5 through 20 of this document are dated
August 25, 1978.)
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207;
telephone<PHONE_NUMBER>, extension 1; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 13, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-24031 Filed 10-1-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12772-12774]
[FR Doc No: 2022-04755]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2022-0018]

Agency Information Collection Activities; Notice and Request for
Comment; Title: FMVSS Considerations for Vehicles With Automated
Driving Systems: Seating Preference Study

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

ACTION: Notice and request for comments on a request for approval of a
new information collection.

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SUMMARY: The National Highway Traffic Safety Administration (NHTSA)
invites public comments about our intention to request approval from
the Office of Management and Budget (OMB) for a new information
collection. Before a Federal agency can collect certain information
from the public, it must receive approval from OMB. Under procedures
established by the Paperwork Reduction Act of 1995, before seeking OMB
approval, Federal agencies must solicit public comment on proposed
collections of information, including extensions and reinstatement of
previously approved collections. This document describes a collection
of information for which NHTSA intends to seek OMB approval to conduct
an experiment to gather both objective and subjective data regarding
occupant/passenger seat preference in Automated Driving System-
Dedicated Vehicles (ADS-DVs).

DATES: Comments must be submitted on or before May 6, 2022.

ADDRESSES: You may submit comments identified by the Docket No. NHTSA-
2022-0018 through any of the following methods:
     Electronic Submissions: Go to the Federal eRulemaking
Portal at http://www.regulations.gov. Follow the online instructions
for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail or Hand Delivery: Docket Management, U.S. Department
of Transportation, 1200 New Jersey Avenue SE, West Building, Room W12-
140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except on Federal holidays. To be sure someone is there to help
you, please call<PHONE_NUMBER> before coming.
    Instructions: All submissions must include the agency name and
docket number for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit https://www.transportation.gov/privacy.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets via internet.

FOR FURTHER INFORMATION CONTACT: For additional information or access
to background documents, contact Arryn Robbins, Office of Behavioral
Safety Research (NPD-320),<PHONE_NUMBER>, National Highway Traffic
Safety Administration, W46-466, U.S. Department of Transportation, 1200
New Jersey Avenue SE, Washington, DC 20590.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), before an agency submits a proposed
collection of information to OMB for approval, it must first publish a
document in the Federal Register providing a 60-day comment period and
otherwise consult with members of the public and affected agencies
concerning each proposed collection of information. The OMB has
promulgated regulations describing what must be included in such a
document. Under OMB's regulation (at 5 CFR 1320.8(d)), an agency must
ask for public comment on the following: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (c) how to enhance
the quality, utility, and clarity of the information to be collected;
and (d) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In compliance with these requirements, NHTSA
asks for public comments on the following proposed collection of
information for which the agency is seeking approval from OMB.
    Title: FMVSS Considerations for Vehicles with Automated Driving
Systems: Seating Preference Study.
    OMB Control Number: New.
    Form Number(s): NHTSA Forms 1624, 1625, and 1626.

                 Table 1--Forms To Be Used in the Study
------------------------------------------------------------------------

------------------------------------------------------------------------
NHTSA Form 1624........................  Eligibility Questionnaire--
                                          FMVSS Considerations for
                                          Vehicles with Automated
                                          Driving Systems: Seating
                                          Preference Study.
NHTSA Form 1625........................  Demographic Questionnaire--
                                          FMVSS Considerations for
                                          Vehicles with Automated
                                          Driving Systems: Seating
                                          Preference Study.
NHTSA Form 1626........................  Post Experiment Questionnaire--
                                          FMVSS Considerations for
                                          Vehicles with Automated
                                          Driving Systems: Seating
                                          Preference Study.
------------------------------------------------------------------------

    Type of Request: New collection.
    Type of Review Requested: Regular.
    Requested Expiration Date of Approval: 3 years from date of
approval.
    Summary of the Collection of Information: 49 U.S.C. 30181, 30182,
and 30183 authorize the Secretary of Transportation (NHTSA by
delegation) to conduct research, development, and testing programs,
including activities related to new and emerging technologies that
impact, or that may impact, motor vehicle safety. NHTSA proposes to
collect information from the public regarding occupant/passenger seat
preference in Automated Driving System-Dedicated Vehicles (ADS-DVs).
Adults aged 18 and older will participate in an on-road study after
giving informed consent. Participants will ride in one passenger
vehicle and two ADS-DVs on a closed test track. Questionnaire data will
be collected at the beginning and end of participation for each
participant. Objective data will be collected via the data acquisition
systems installed in each study vehicle. The data from each participant
will be combined, stratified by demographic information and analyzed.
    There are four information collections for the study. The (1)
Eligibility

Questionnaire will be used to identify eligible participants for this
study; results from this questionnaire will not be kept or analyzed.
Candidates who are selected for the study will participate in a single
test-track experiment and will complete two additional questionnaires
while participating in the experiment. The (2) Demographic
Questionnaire will be used for description of the participant sample
(e.g., number of males and females in the dataset, final age range for
all participants, and driving experience range for all participants).
This is necessary to compare the sample collected to the general
driving population. The (3) objective data collected via data
acquisition systems installed in each study vehicle during the test-
track experiment is necessary for collecting information about
participants' seat selection, any seat changes during the ride, seat
belt use, and how participants interact with the HMI. The (4) Post
Experiment Questionnaire will be used to analyze the perceptions and
opinions of ADS-DV technology within the participant sample, as well as
to gather any comments regarding their seat preference and seat belt
use. This data will be used to determine how and why participants
choose seating preferences in ADS-DVs.

Description of the Need for the Information and Proposed Use of the
Information

    The National Highway Traffic Safety Administration's (NHTSA's)
mission is to save lives, prevent injuries, and reduce economic losses
resulting from motor vehicle crashes. ADS technology is rapidly
developing, and current Federal motor vehicle safety standards (FMVSS)
and/or NHTSA guidance may need to be adapted to ensure this technology
is deployed safely. Many of NHTSA's FMVSS focus on particular seating
positions and thus, changes in seating preferences could impact those
FMVSS. This study will provide NHTSA information about the seating
preferences of occupants in vehicles that do not require a human driver
in the left front seat. Several safety outcomes stem from occupant
seating preference, which may change in the future as Automated Driving
Systems (ADS) change seating configurations and the way people use
vehicles. ADS-Dedicated Vehicles (ADS-DVs) are vehicles that lack
manually operated driving controls, and therefore do not require a
human driver or occupant to drive the vehicle or sit in the left front
seat (the ``driver's seat'' in conventional vehicles). In conventional
vehicles, there is the basic assumption that a human will always be in
the left front seat while the vehicle is operating because a human
driver would be necessary to operate those vehicles. ADS-DVs provide
the opportunity for occupants to sit in any seat they choose in the
vehicle. It is currently unknown where occupants may choose to sit when
riding in an ADS-DV. Moreover, new seating configurations for occupants
of ADS-DVs may necessitate changes to how and where information is
presented to occupants about their responsibilities as occupants (e.g.,
closing doors, fastening seatbelts). Furthermore, occupants will need a
human-machine interface (HMI) to provide input that they are ready for
the ride to begin, or to request that the ride stop. At present, no
standardized or otherwise commercially produced HMIs exist for this
purpose. Therefore, in order to conduct the research, a prototype HMI
will be developed. The two main goals for this study are to:
    1. Describe the occupant distribution for ADS-DVs (i.e., seating
distribution).
    2. Use the prototype HMI to evaluate whether occupants would choose
to initiate a ride in an ADS-DV without a seatbelt.
    Affected Public: Adults ages 18 and older who meet eligibility
criteria such as holding a valid driver's license and having used a
ride-sharing application at least once in the past year.
    Estimated Number of Respondents: An expected total of up to 100
participants will be recruited to participate in the study. It is
estimated that 200 respondents will be needed in order to identify 100
eligible participants.
    Frequency: One-time collection.
    Estimated Total Annual Burden Hours: 268.
    The eligibility questionnaire will have a maximum of 28 questions
and NHTSA estimates it will take approximately 20 minutes to complete.
Therefore, NHTSA estimates the total time associated with completing
eligibility questionnaires to be 67 hours (200 responses x 20 minutes =
66.7 hours). Study Intake, (reading study information sheet and
obtaining participant consent, general study instruction) is expected
to take 10 minutes to complete. Both the demographic and post-
experiment questionnaires will have a maximum of 20 questions and NHTSA
estimates that it will take each eligible participant 10 minutes to
complete the demographic questionnaire and 10 minutes to complete the
post-experiment questionnaire. Therefore, NHTSA estimates the total
burden for Study Intake to be 17 hours (100 responses x 10 minutes =
16.67 hours), Demographic Questionnaire to be 17 hours (100 responses x
10 minutes = 16.67 hours), and The Post Experiment questionnaire to be
17 hours (100 responses x 10 minutes = 16.67 hours). Accordingly, NHTSA
estimates the total burden hours for this information collection to be
268 hours.
    The table below shows the estimated burden hours for this
information collection, which accounts for the maximum number of
expected responses and drop-outs.

                         Estimated Burden Hours
------------------------------------------------------------------------
                                                 Estimated      Total
                                     Maximum     individual   estimated
            Instrument              number of      burden       burden
                                   respondents   (minutes)      hours
------------------------------------------------------------------------
Eligibility Questionnaire........          200           20           67
Study Intake.....................          100           10           17
Demographic questionnaire........          100           10           17
Study Participation..............          100           90          150
Post Experiment Questionnaire....          100           10           17
                                  --------------------------------------
    Total........................          200           60          268
------------------------------------------------------------------------

    Estimated Total Annual Burden Cost: The only cost burdens
respondents will incur are costs related to travel to and from the
study location. The costs are minimal and are expected to be offset by

the honorarium that will be provided to all research participants.
    Public Comments Invited: You are asked to comment on any aspects of
this information collection, including (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; (b) the accuracy of the Department's estimate
of the burden of the proposed information collection; (c) ways to
enhance the quality, utility and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended; 49 CFR 1.49; and DOT Order 1351.29.

Cem Hatipoglu,
Associate Administrator, Vehicle Safety Research.
[FR Doc. 2022-04755 Filed 3-4-22; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: August 2, 2007 (Volume 72, Number 148)]
[Notices]
[Page 42406-42408]
[DOCID:fr02au07-86]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

July 25, 2007.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC07-117-000.
    Applicants: Sunbury Generation LP; Corona Power, LLC.
    Description: Joint Application of Sunbury Generation LP and Corona
Power LLC for authorization under section 203 of the Federal Power Act.
    Filed Date: July 18, 2007.
    Accession Number: 20070720-0050.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 8, 2007.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG07-57-000.
    Applicants: EL Segundo Power II LLC.
    Description: Notice of Self-Certification of EL Segundo Power II
LLC of exempt wholesale generator status.
    Filed Date: July 6, 2007.
    Accession Number: 20070606-5040.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 1, 2007.

    Docket Numbers: EG07-57-000.
    Applicants: EL Segundo Power II LLC.
    Description: Clarification of June 6, 2007 filing of EL Segundo
Power II LLC.

    Filed Date: June 26, 2007.
    Accession Number: 20070626-5027.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 1, 2007.

    Docket Numbers: EG07-61-000.
    Applicants: Warm Springs Biomass Project, LLC.
    Description: Amendment to Notice of Self-Certification of Exempt
Wholesale Generator Status.
    Filed Date: July 12, 2007.
    Accession Number: 20070711-5233.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 2, 2007.

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

    Docket Numbers: ER01-666-009.
    Applicants: EWO Marketing, LP.
    Description: EWO Marketing LP submits the refund report related to
refunds.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0180.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER04-831-003.
    Applicants: Calpine Newark, LLC.
    Description: Calpine Newark, LLC submits an updated market analysis
in accordance with FERC's letter order dated July 21, 2004.
    Filed Date: July 23, 2007.
    Accession Number: 20070724-0200.
    Comment Date: 5 p.m. Eastern Time on Monday, August 13, 2007.

    Docket Numbers: ER04-925-017.
    Applicants: Merrill Lynch Commodities, Inc.
    Description: Triennial Updated Market Power Analysis for Merrill
Lynch Commodities, Inc.
    Filed Date: July 19, 2007.
    Accession Number: 20070724-0175.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 9, 2007.

    Docket Numbers: ER06-739-006; ER06-738-006; ER03-983-005; ER07-501-
002; ER07-758-001; ER02-537-009.
    Applicants: Cogen Technologies Linden Venture, L.P.
    Description: Cogen Technologies Linden Venture, LP et al notifies
FERC of a change in status resulting from the acquisition of a 100
percent indirect interest in Shady Hills by General Electric Capital
Corp.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0178.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER07-570-003.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
revised Market Administration and Control Area Services Tariff and Open
Access Transmission Tariff Sheets in compliance w/FERC's July 21, 2007
order.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0179.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER07-946-002; ER07-947-002; ER07-948-002.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits First Revised Sheet 8 to
1st Revised FERC Electric Rate Schedule 226.
    Filed Date: July 19, 2007.
    Accession Number: 20070724-0176.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 9, 2007.

    Docket Numbers: ER07-954-001.
    Applicants: American Transmission Company LLC.
    Description: American Transmission Company LLC submits a response
to an informal request for information by FERC Staff regarding the
amended Distribution-Transmission Interconnection Agreement filed on
May 25, 2007.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0177.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER07-1171-001.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Co submits an errata to the
corrected version of the tariff sheets filed in section 205 Filing.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0135.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER07-1175-000.
    Applicants: Illinois Power Company d/b/a AmerenIP.
    Description: Illinois Power Co dba AmerenIP's et al requests
approval of the Joint Ownership Agreement with Ameren Transco.
    Filed Date: July 19, 2007.
    Accession Number: 20070724-0130.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 9, 2007.

    Docket Numbers: ER07-1176-000.
    Applicants: Niagara Mohawk Power Corporation.
    Description: Niagra Mohawk Power Co submits a notice of
Cancellation of Rate Schedule 172 with Lockport Energy Associates, LP.
    Filed Date: July 19, 2007.
    Accession Number: 20070724-0131.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 9, 2007.

    Docket Numbers: ER07-1177-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits an executed Small Generator Interconnection Agreement with Odin
Wind Farm, LLC.
    Filed Date: July 19, 2007.
    Accession Number: 20070724-0132.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 9, 2007.

    Docket Numbers: ER07-1178-000.
    Applicants: Xcel Energy Operating Companies.
    Description: Xcel Energy Services Inc submits the Revised and
Restated Interconnection and Interchange Agreement dated July 23, 2007
b/w Northern States Power Company (Minnesota), Northern States Power Co
(Wisconsin) etc.
    Filed Date: July 19, 2007.
    Accession Number: 20070724-0186.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 9, 2007.

    Docket Numbers: ER07-1179-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits its quarterly
filing of Facilities Agreements pursuant to the Procedures for
Implementation of section 3.3 of the 1987 Agreement.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0182.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER07-1180-000.
    Applicants: California Independent System Operator Corporation
    Description: Petition of the California Independent System Operator
Corp to waive sanctions for violation of section <IP_ADDRESS> of its tariff
through October 18, 2006.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0137.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER07-1181-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits a
single limited revision to its Open Access Transmission Tariff.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0136.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER07-1182-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits its request for an extension of the Broad Constrained Area
mitigation measures provided in their Open Access Transmission & energy
Markets Tariff.

    Filed Date: July 20, 2007.
    Accession Number: 20070724-0134.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

    Docket Numbers: ER07-1183-000.
    Applicants: Susquehanna Energy Products, LLC.
    Description: SIG Energy, LLLP submits a supplement to its June 8,
2007 Notice of Succession.
    Filed Date: July 20, 2007.
    Accession Number: 20070724-0133.
    Comment Date: 5 p.m. Eastern Time on Friday, August 10, 2007.

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

    Docket Numbers: ES07-41-000.
    Applicants: Duquesne Light Company.
    Description: Duquesne Light Co's Filing of Pro Forma Financial
Statements.
    Filed Date: July 19, 2007.
    Accession Number: 20070719-5054.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 9, 2007.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose
Secretary.
 [FR Doc. E7-14957 Filed 8-1-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Pages 6972-6996]
[FR Doc No: 2015-02467]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0126]

Authorizations of Emergency Use of In Vitro Diagnostic Devices
for Detection of Ebola Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of three Emergency Use Authorizations (EUAs) (the
Authorizations), one of which was amended after initial issuance, for
three in vitro diagnostic devices for detection of the Ebola virus in
response to the 2014 Ebola virus outbreak in West Africa. FDA is
issuing these Authorizations under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by BioFire Defense, LLC (BioFire
Defense) and altona Diagnostics GmbH (altona). The Authorizations
contain, among other things, conditions on the emergency use of the
authorized in vitro diagnostic devices. The Authorizations follow the
September 22, 2006, determination by then-Secretary of the Department
of Homeland Security (DHS), Michael Chertoff, that the Ebola virus
presents a material threat against the U.S. population sufficient to
affect national security. On the basis of such determination, the
Secretary of Health and Human Services (HHS) declared on August 5,
2014, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection of Ebola virus
subject to the terms of any authorization issued under the FD&C Act.
The Authorizations, which include an explanation of the reasons for
issuance, are reprinted in this document.

DATES: The Authorizations for the BioFire FilmArray NGDS BT-E Assay and
BioFire FilmArray Biothreat-E test are effective as of October 25,
2014. The Authorization for the altona RealStar[supreg] Ebolavirus RT-
PCR Kit 1.0, which was amended and reissued on November 26, 2014, is
effective as of November 10, 2014.

ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION

section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Luciana Borio, Assistant Commissioner
for Counterterrorism Policy, Office of Counterterrorism and Emerging
Threats, and Acting Deputy Chief Scientist, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver
Spring, MD 20993-0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of DHS that there is a domestic
emergency, or a significant potential for a domestic emergency,
involving a heightened risk of attack with a biological, chemical,
radiological, or nuclear agent or agents; (2) a determination by the
Secretary of the Department of Defense that there is a military
emergency, or a significant potential for a military emergency,
involving a heightened risk to U.S. military forces of attack with a
biological, chemical, radiological, or nuclear agent or agents; (3) a
determination by the Secretary of HHS that there is a public health
emergency, or a significant potential for a public health emergency,
that affects, or has a significant potential to affect, national
security or the health and security of U.S. citizens living abroad, and
that involves a biological, chemical, radiological, or nuclear agent or
agents, or a disease or condition that may be attributable to such
agent or agents; or (4) the identification of a material threat by the
Secretary of DHS under section 319F-2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the CDC (to the extent feasible and
appropriate given the applicable circumstances), FDA \1\ concludes: (1)
That an agent referred to in a declaration of emergency or threat can
cause a serious or life-threatening disease or condition; (2) that,
based on the totality of scientific evidence available to FDA,
including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that: (A) The product may be
effective in diagnosing, treating, or preventing (i) such disease or
condition; or (ii) a serious or life-threatening disease or condition
caused by a product authorized under section 564, approved or cleared
under the FD&C Act, or licensed under section 351 of the PHS Act, for
diagnosing, treating, or preventing such a disease or condition caused
by such an agent; and (B) the known and potential benefits of the
product, when used to diagnose, prevent, or treat such disease or
condition, outweigh the known and potential risks of the product,
taking into consideration the material threat posed by the agent or
agents identified in a declaration under section 564(b)(1)(D) of the
FD&C Act, if applicable; (3) that there is no adequate, approved, and
available alternative to the product for diagnosing, preventing, or
treating such disease or condition; and (4) that such other criteria as
may be prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Requests for In Vitro Diagnostic Devices for Detection of the
Ebola Virus

    On September 22, 2006, then-Secretary of DHS, Michael Chertoff,
determined that the Ebola virus presents a material threat against the
U.S. population sufficient to affect national security.\2\ On August 5,
2014, under section 564(b)(1) of the FD&C Act, and on the basis of such
determination, the Secretary of HHS declared that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics
for detection of Ebola virus, subject to the terms of any authorization
issued under section 564 of the FD&C Act. Notice of the declaration of
the Secretary was published in the Federal Register on August 12, 2014
(79 FR 47141). On October 22, 2014, BioFire Defense submitted complete
EUA requests for both the BioFire FilmArray NGDS BT-E Assay and for the
BioFire FilmArray Biothreat-E test, and on October 25, 2014, FDA
issued, an EUA for the BioFire FilmArray NGDS BT-E Assay and an EUA for
the BioFire FilmArray Biothreat-E test, subject to the terms of these
authorizations. On October 29, 2014, altona submitted a complete EUA
request for the RealStar[supreg] Ebolavirus RT-PCR Kit 1.0, and on
November 10, 2014, FDA issued, an EUA for the RealStar[supreg]
Ebolavirus RT-PCR Kit 1.0, subject to the terms of this authorization.
On November 26, 2014, in response to a request from altona on November
18, 2014, FDA amended and reissued in its entirety the EUA to allow, in
addition to altona, distributors that are authorized by altona to
distribute the

RealStar[supreg] Ebolavirus RT-PCR Kit 1.0 with certain conditions
applicable to such authorized distributor(s), and to allow the use of
the assay under the EUA at certain non-U.S. laboratories, with certain
conditions. The EUA, as amended and reissued on November 26, 2014,
which includes an explanation for its reissuance, is reprinted in this
document. Because the November 26, 2014, Authorization for altona's
Ebola assay replaces in its entirety the EUA issued on November 10,
2014, the original Authorization issued on November 10, 2014, is not
reprinted in this document.
---------------------------------------------------------------------------

    \2\ Under to section 564(b)(1) of the FD&C Act, the HHS
Secretary's declaration that supports EUA issuance must be based on
one of four determinations, including the identification by the
Secretary of DHS of a material threat under to section 319F-2 of the
PHS Act sufficient to affect national security or the health and
security of U.S. citizens living abroad (section 564(b)(1)(D) of the
FD&C Act).
---------------------------------------------------------------------------

III. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the Internet at http://www.regulations.gov.

IV. The Authorizations

    Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of certain in vitro diagnostic devices.
The Authorization for the BioFire FilmArray NGDS BT-E Assay issued on
October 25, 2014, in its entirety (not including the authorized
versions of the fact sheets and other written materials) follows and
provides an explanation of the reasons for its issuance, as required by
section 564(h)(1) of the FD&C Act:
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN09FE15.000

[GRAPHIC] [TIFF OMITTED] TN09FE15.001

[GRAPHIC] [TIFF OMITTED] TN09FE15.002

[GRAPHIC] [TIFF OMITTED] TN09FE15.003

[GRAPHIC] [TIFF OMITTED] TN09FE15.004

[GRAPHIC] [TIFF OMITTED] TN09FE15.005

[GRAPHIC] [TIFF OMITTED] TN09FE15.006

    The Authorization for the BioFire FilmArray Biothreat-E test issued
October 25, 2014, in its entirety (not including the authorized
versions of the fact sheets and other written materials) follows and
provides an explanation of the reasons for its issuance, as required by
section 564(h)(1) of the FD&C Act:

[GRAPHIC] [TIFF OMITTED] TN09FE15.007

[GRAPHIC] [TIFF OMITTED] TN09FE15.008

[GRAPHIC] [TIFF OMITTED] TN09FE15.009

[GRAPHIC] [TIFF OMITTED] TN09FE15.010

[GRAPHIC] [TIFF OMITTED] TN09FE15.011

[GRAPHIC] [TIFF OMITTED] TN09FE15.012

[GRAPHIC] [TIFF OMITTED] TN09FE15.013

    The Authorization for the RealStar[supreg] Ebolavirus RT-PCR Kit
1.0, originally issued on November 10, 2014, as amended and reissued in
its entirety on November 26, 2014, (not including the authorized
versions of the fact sheets and other written materials) follows and
provides an explanation of the reasons for its issuance, as required by
section 564(h)(1) of the FD&C Act, and its amendment:

[GRAPHIC] [TIFF OMITTED] TN09FE15.014

[GRAPHIC] [TIFF OMITTED] TN09FE15.015

[GRAPHIC] [TIFF OMITTED] TN09FE15.016

[GRAPHIC] [TIFF OMITTED] TN09FE15.017

[GRAPHIC] [TIFF OMITTED] TN09FE15.018

[GRAPHIC] [TIFF OMITTED] TN09FE15.019

[GRAPHIC] [TIFF OMITTED] TN09FE15.020

[GRAPHIC] [TIFF OMITTED] TN09FE15.021

    Dated: February 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02467 Filed 2-6-15; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Notices]
[Pages 26412-26413]
[FR Doc No: 2019-11854]

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

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: EC19-96-000.
    Applicants: Grady Wind Energy Center, LLC, Pattern Energy Group
Inc.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of Grady Wind Energy Center, LLC, et al.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5351.
    Comments Due: 5 p.m. ET 6/21/19.

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

    Docket Numbers: ER10-1437-010.
    Applicants: Tampa Electric Company.
    Description: Notice of Change in Status of Tampa Electric Company.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5218.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER10-2794-029; ER12-1825-027; ER14-2672-014.
    Applicants: EDF Trading North America, LLC, EDF Energy Services,
LLC, EDF Industrial Power Services (CA), LLC.
    Description: Notice of Non-Material Change in Status of the EDF
Sellers.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5526.
    Comments Due: 5 p.m. ET 6/20/19.

    Docket Numbers: ER17-1531-003.
    Applicants: CPV Fairview, LLC.
    Description: Supplement (Confidential Attachment A) to May 3, 2019
Supplement to January 17, 2019 Notice of Change in Status of CPV
Fairview, LLC.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5537.
    Comments Due: 5 p.m. ET 6/20/19.

    Docket Numbers: ER18-734-002.
    Applicants: Frenchtown III Solar, LLC.
    Description: Compliance filing: Frenchtown III Solar Compliance
Filing to be effective 4/1/2018.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5504.
    Comments Due: 5 p.m. ET 6/20/19.

    Docket Numbers: ER18-1226-002.
    Applicants: PA Solar Park, LLC.
    Description: Compliance filing: PA Solar Park Compliance Filing to
be effective 6/1/2018.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5094.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER19-467-002.
    Applicants: New York Independent System Operator, Inc.
    Description: Compliance filing: Compliance re: Electric storage
facility participation in markets as ELRs to be effective 12/31/9998.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5374.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER19-511-002.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Compliance Filing Pursuant to May
3, 2019 Order re: Peak Shaving Adjustments to be effective 2/5/2019.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5398.
    Comments Due: 5 p.m. ET 6/20/19.

    Docket Numbers: ER19-1180-000.
    Applicants: First Choice Energy LLC.
    Description: Report Filing: Refund Report Filing to be effective N/
A.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5406.
    Comments Due: 5 p.m. ET 6/20/19.

    Docket Numbers: ER19-2011-000.
    Applicants: New Brunswick Energy Marketing Corporation.
    Description: Request for Limited Waiver of New Brunswick Energy
Marketing Corporation.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5365.
    Comments Due: 5 p.m. ET 6/13/19.

    Docket Numbers: ER19-2015-000.
    Applicants: Virginia Electric and Power Company, Monongahela Power
Company, The Potomac Edison Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Dominion, Potomac and
Monongahela submit Interconnection Agreement SA No. 4874 to be
effective 4/30/2019.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5427.
    Comments Due: 5 p.m. ET 6/20/19.

    Docket Numbers: ER19-2016-000.
    Applicants: AC Energy, LLC.
    Description: Notice of Cancellation of Market-Based Rate Tariff of
AC Energy, LLC.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5521.
    Comments Due: 5 p.m. ET 6/20/19.

    Docket Numbers: ER19-2017-000.
    Applicants: San Diego Gas & Electric Company.
    Description: Informational Filing [Cycle 8] of Transmission Owner
Rate Appendix X Formula rate mechanism of San Diego Gas & Electric
Company.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5522.
    Comments Due: 5 p.m. ET 6/20/19.

    Docket Numbers: ER19-2018-000.
    Applicants: Wolverine Power Supply Cooperative, Inc.
    Description: Sec.  205(d) Rate Filing: Application to Modify
Reactive Power Revenue Requirements for Rate Schedule 20 to be
effective 6/1/2019.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5196.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER19-2019-000.
    Applicants: Tucson Electric Power Company.
    Description: Sec.  205(d) Rate Filing: Formula Transmission Rate to
be effective 8/1/2019.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5197.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER19-2020-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-05-31_SA 3304 Lincoln
Land Wind-Ameren GIA (J757) to be effective 5/16/2019.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5205.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER19-2021-000.
    Applicants: New England Power Pool Participants Committee.
    Description: Sec.  205(d) Rate Filing: Jun 2019 Membership Filing
to be effective 5/1/2019.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5209.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER19-2022-000.
    Applicants: PacifiCorp.
    Description: Tariff Cancellation: Termination of Exelon NITSA (OR
D.A.) to be effective 7/31/2019.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5213.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER19-2023-000.
    Applicants: Tucson Electric Power Company.
    Description: Application for Abandoned Plant Cost Recovery of
Tucson Electric Power Company.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5347.
    Comments Due: 5 p.m. ET 6/21/19.

    Docket Numbers: ER19-2024-000.
    Applicants: Pacific Gas and Electric Company.

    Description: Sec.  205(d) Rate Filing: May 2019 Western
Interconnection Agreement Biannual Filing to be effective 8/1/2019.
    Filed Date: 5/31/19.
    Accession Number: 20190531-5368.
    Comments Due: 5 p.m. ET 6/21/19.

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

    Docket Numbers: ES19-31-000.
    Applicants: Duquesne Light Company.
    Description: Duguesne Light Company submits Application for an
Order Authorizing the Issuance of Short--Term Indebtedness.
    Filed Date: 5/30/19.
    Accession Number: 20190531-0001.
    Comments Due: 5 p.m. ET 6/20/19.

    Take notice that the Commission received the following electric
reliability filings.

    Docket Numbers: RD19-6-000.
    Applicants: North American Electric Reliability Corporation,
Western Electricity Coordinating Council.
    Description: Joint Petition of North American Electric Reliability
Corporation and Western Electricity Coordinating Council for Approval
of Proposed Reliability Standard IRO-002-6.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5525.
    Comments Due: 5 p.m. ET 7/1/19.

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

    Docket Numbers: RR19-6-000.
    Applicants: North American Electric Reliability Corporation.
    Description: North American Electric Reliability Corporation's
Report of Comparisons of Budgeted to Actual Costs for 2018 for NERC and
the Regional Entities.
    Filed Date: 5/30/19.
    Accession Number: 20190530-5519.
    Comments Due: 5 p.m. ET 6/20/19.

    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: May 31, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-11854 Filed 6-5-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 2, 2009 (Volume 74, Number 230)]
[Notices]
[Page 63170-63171]
[DOCID:fr02de09-63]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) revision of a current
information

collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on September 8, 2009, vol. 74, no. 172, page 46292.
Fractional Ownership is a program that offers increased flexibility in
aircraft ownership.

DATES: Please submit comments by January 4, 2010.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Fractional Aircraft Ownership Programs.
    Type of Request: Revision of a currently approved collection.
    OMB Control Number: 2120-0684.
    Form(s): There are no FAA forms associated with this collection.
    Affected Public: An estimated 11 Respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden per Response: Approximately 45 minutes per
response.
    Estimated Annual Burden Hours: An estimated 19,609 hours annually.
    Abstract: Fractional Ownership is a program that offers increased
flexibility in aircraft ownership. Owners purchase shares of an
aircraft and agree to share their aircraft with others having an
ownership share in that same aircraft. Owners agree to put their
aircraft into a ``pool'' of other shared aircraft and to lease their
aircraft to another owner in that pool. The aircraft owners use a
common management company to maintain the aircraft and administer the
leasing of the aircraft among the owners.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to oira_
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on November 24, 2009.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. E9-28829 Filed 12-1-09; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: December 10, 2009 (Volume 74, Number 236)]
[Rules and Regulations]
[Page 65458-65460]
[DOCID:fr10de09-16]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 225

[FRA-2008-0136, Notice No. 1]
RIN 2130-ZA02

Adjustment of Monetary Threshold for Reporting Rail Equipment
Accidents/Incidents for Calendar Year 2010

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: This rule increases the rail equipment accident/incident
reporting threshold from $8,900 to $9,200 for certain railroad
accidents/incidents involving property damage that occur during
calendar year 2010. This action is needed to ensure that FRA's
reporting requirements reflect cost increases that have occurred since
the reporting threshold was last computed in December of 2008.

DATES: This regulation is effective January 1, 2010.

FOR FURTHER INFORMATION CONTACT: Arnel B. Rivera, Staff Director, U.S.
Department of Transportation, Federal Railroad Administration, Office
of Safety Analysis, RRS-22, Mail Stop 25, West Building 3rd Floor, Room
W33-306, 1200 New Jersey Ave., SE., Washington, DC 20590 (telephone
202-493-1331); or Gahan Christenson, Trial Attorney, U.S. Department of
Transportation, Federal Railroad Administration, Office of Chief
Counsel, RCC-10, Mail Stop 10, West Building 3rd Floor, Room W31-204,
1200 New Jersey Ave., SE., Washington, DC 20590 (telephone 202-493-
1381).

SUPPLEMENTARY INFORMATION:

Background

    A ``rail equipment accident/incident'' is a collision, derailment,
fire, explosion, act of God, or other event involving the operation of
railroad on-track equipment (standing or moving) that results in
damages to railroad on-track equipment, signals, tracks, track
structures, or roadbed, including labor costs and the costs for
acquiring new equipment and material, greater than the reporting
threshold for the year in which the event occurs. 49 CFR 225.19(c).
Each rail equipment accident/incident must be reported to FRA using the
Rail Equipment Accident/Incident Report (Form FRA F 6180.54). 49 CFR
225.19(b) and (c). As revised, effective in 1997, paragraphs (c) and
(e) of 49 CFR 225.19 provide that the dollar figure that constitutes
the reporting threshold for rail equipment accidents/incidents will be
adjusted, if necessary, every year in accordance with the procedures
outlined in appendix B to part 225 to reflect any cost increases or
decreases.

New Reporting Threshold

    Approximately one year has passed since the rail equipment
accident/incident reporting threshold was revised. 73 FR 78657
(December 23, 2008). Consequently, FRA has recalculated the threshold,
as required by Sec.  225.19(c), based on increased costs for labor and
increased costs for equipment. FRA has determined that the current
reporting threshold of $8,900, which applies to rail equipment
accidents/incidents that occur during calendar year 2009, should
increase by $300 to $9,200 for equipment accidents/incidents occurring
during calendar year 2010, effective January 1, 2010. The specific
inputs to the equation set forth in appendix B (i.e., Tnew = Tprior *
[1 + 0.4(Wnew - Wprior)/Wprior + 0.6(Enew - Eprior)/100]) to part 225
are:

----------------------------------------------------------------------------------------------------------------
                   Tprior                           Wnew            Wprior            Enew            Eprior
----------------------------------------------------------------------------------------------------------------
$8,900......................................       $24.04379        $22.86094        182.03333        180.16667
----------------------------------------------------------------------------------------------------------------

    Where: Tnew = New threshold; Tprior = Prior threshold (with
reference to the threshold, ``prior'' refers to the previous threshold
rounded to the nearest $100, as reported in the Federal Register); Wnew
= New average hourly wage rate, in dollars; Wprior = Prior average
hourly wage rate, in dollars; Enew = New equipment average PPI value;
Eprior = Prior equipment average PPI value. Using the above figures,
the calculated new threshold, (Tnew) is $9,183.88, which is rounded to
the nearest $100 for a final new reporting threshold of $9,200.

Notice and Comment Procedures and Effective Date

    In this rule, FRA has recalculated the monetary reporting threshold
based on the formula discussed in detail and adopted, after notice and
comment, in the final rule published December 20, 2005, 70 FR 75414.
FRA has found that both the current cost data inserted into this pre-
existing formula and the original cost data that they replace were
obtained from reliable Federal government sources. FRA has found that
this rule imposes no additional burden on any person, but rather
provides a benefit by permitting the valid comparison of accident data
over time. Accordingly, finding that notice and comment procedures are
either impracticable, unnecessary, or contrary to the public interest,
FRA is proceeding directly to the final rule.
    FRA regularly recalculates the monetary reporting threshold using a
pre-existing formula near the end of each calendar year. Therefore, any
person affected by this rule anticipates the on-going adjustment of the
threshold and has reasonable time to make any minor changes necessary
to come into compliance with the regulations. FRA attempts to use the
most recent data available to calculate the updated reporting threshold
prior to the next calendar year. FRA has found that issuing the rule in
December of each calendar year and making the rule effective on January
1, of the next year, allows FRA to use the most up-to-date data when
calculating the reporting threshold and to compile data that accurately
reflects rising wages and equipment costs. As such, FRA has

found that it has good cause to make the effective date January 1,
2010.

Regulatory Impact

Executive Order 12866 and DOT Regulatory Policies and Procedures

    This rule has been evaluated in accordance with existing policies
and procedures, and determined to be non-significant under both
Executive Order 12866 and DOT policies and procedures (44 FR 11034
(Feb. 26, 1979)).

Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) requires
a review of proposed and final rules to assess their impact on small
entities, unless the Secretary certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Pursuant to Section 312 of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), FRA has issued a final policy
that formally establishes ``small entities'' as including railroads
that meet the line-haulage revenue requirements of a Class III
railroad. 49 CFR part 209, app. C. For other entities, the same dollar
limit in revenues governs whether a railroad, contractor, or other
respondent is a small entity. Id.
    About 696 of the approximately 731 railroads in the United States
are considered small entities by FRA. FRA certifies that this final
rule will have no significant economic impact on a substantial number
of small entities. To the extent that this rule has any impact on small
entities, the impact will be neutral or insignificant. The frequency of
rail equipment accidents/incidents, and therefore also the frequency of
required reporting, is generally proportional to the size of the
railroad. A railroad that employs thousands of employees and operates
trains millions of miles is exposed to greater risks than one whose
operation is substantially smaller. Small railroads may go for months
at a time without having a reportable occurrence of any type, and even
longer without having a rail equipment accident/incident. For example,
current FRA data indicate that 3,266 rail equipment accidents/incidents
were reported in 2005, with small railroads reporting 348 of them. In
2006, 2,990 rail equipment accidents/incidents were reported, and small
railroads reported 374 of them. Data for 2007 show that 2,685 rail
equipment accidents/incidents were reported, with small railroads
reporting 359 of them. Data for 2008 show that 2,448 rail equipment
accidents/incidents were reported, with small railroads reporting 291
of them. On average for those four calendar years, small railroads
reported about 12% (ranging from 11% to 13%) of the total number of
rail equipment accidents/incidents. FRA notes that these data are
accurate as of the date of issuance of this final rule, and are subject
to minor changes due to additional reporting. Absent this rulemaking
(i.e., any increase in the monetary reporting threshold), the number of
reportable accidents/incidents would increase, as keeping the 2009
threshold in place would not allow it to keep pace with the increasing
dollar amounts of wages and rail equipment repair costs. Therefore,
this rule will be neutral in effect. Increasing the reporting threshold
will slightly decrease the recordkeeping burden for railroads over
time. Any recordkeeping burden will not be significant and will affect
the large railroads more than the small entities, due to the higher
proportion of reportable rail equipment accidents/incidents experienced
by large entities.

Paperwork Reduction Act

    There are no new information collection requirements associated
with this final rule. Therefore, no estimate of a public reporting
burden is required.

Federalism Implications

    Executive Order 13132, entitled, ``Federalism,'' issued on August
4, 1999, requires that each agency ``in a separately identified portion
of the preamble to the regulation as it is to be issued in the Federal
Register, provide[] to the Director of the Office of Management and
Budget a federalism summary impact statement, which consists of a
description of the extent of the agency's prior consultation with State
and local officials, a summary of the nature of their concerns and the
agency's position supporting the need to issue the regulation, and a
statement of the extent to which the concerns of the State and local
officials have been met * * *.'' This rulemaking action has been
analyzed in accordance with the principles and criteria contained in
Executive Order 13132. This rule will not have a substantial direct
effect on States, on the relationship between the National Government
and the States, or on the distribution of power and the
responsibilities among the various levels of government, as specified
in the Executive Order 13132. Accordingly, FRA has determined that this
rule will not have sufficient federalism implications to warrant
consultation with State and local officials or the preparation of a
federalism assessment. Accordingly, a federalism assessment has not
been prepared.

Environmental Impact

    FRA has evaluated this regulation in accordance with its
``Procedures for Considering Environmental Impacts'' (FRA's Procedures)
(64 FR 28545, May 26, 1999) as required by the National Environmental
Policy Act (42 U.S.C. 4321 et seq.), other environmental statutes,
Executive Orders, and related regulatory requirements. FRA has
determined that this regulation is not a major FRA action (requiring
the preparation of an environmental impact statement or environmental
assessment) because it is categorically excluded from detailed
environmental review pursuant to section 4(c)(20) of FRA's Procedures.
64 FR 28545, 28547, May 26, 1999. In accordance with section 4(c) and
(e) of FRA's Procedures, the agency has further concluded that no
extraordinary circumstances exist with respect to this regulation that
might trigger the need for a more detailed environmental review. As a
result, FRA finds that this regulation is not a major Federal action
significantly affecting the quality of the human environment.

Unfunded Mandates Reform Act of 1995

    Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency ``shall, unless
otherwise prohibited by law, assess the effects of Federal regulatory
actions on State, local, and Tribal governments, and the private sector
(other than to the extent that such regulations incorporate
requirements specifically set forth in law).'' Section 202 of the Act
(2 U.S.C. 1532) further requires that ``before promulgating any general
notice of proposed rulemaking that is likely to result in the
promulgation of any rule that includes any Federal mandate that may
result in expenditure by State, local, and Tribal governments, in the
aggregate, or by the private sector, of [$141,300,000 or more (as
adjusted for inflation)] in any one year, and before promulgating any
final rule for which a general notice of proposed rulemaking was
published, the agency shall prepare a written statement'' detailing the
effect on State, local, and Tribal governments and the private sector.
The final rule will not result in the expenditure, in the aggregate, of
$141,300,000 or more in any one year, and thus preparation of such a
statement is not required.

Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a
Statement

of Energy Effects for any ``significant energy action.'' 66 FR 28355
(May 22, 2001). Under the Executive Order, a ``significant energy
action'' is defined as any action by an agency (normally published in
the Federal Register) that promulgates or is expected to lead to the
promulgation of a final rule or regulation, including notices of
inquiry, advance notices of proposed rulemaking, and notices of
proposed rulemaking: That (1)(i) is a significant regulatory action
under Executive Order 12866 or any successor order, and (ii) is likely
to have a significant adverse effect on the supply, distribution, or
use of energy; or (2) that is designated by the Administrator of the
Office of Information and Regulatory Affairs as a significant energy
action. FRA has evaluated this final rule in accordance with Executive
Order 13211. FRA has determined that this final rule is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. Consequently, FRA has determined that this regulatory action
is not a ``significant energy action'' within the meaning of Executive
Order 13211.

Privacy Act

    Anyone is able to search the electronic form of all our comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.regulations.gov.

List of Subjects in 49 CFR Part 225

    Investigations, Penalties, Railroad safety, Reporting and
recordkeeping requirements.

The Rule

0
In consideration of the foregoing, FRA amends part 225 of chapter II,
subtitle B of title 49, Code of Federal Regulations, as follows:

PART 225--[AMENDED]

0
1. The authority citation for part 225 continues to read as follows:

    Authority: 49 U.S.C. 103, 322(a), 20103, 20107, 20901-02, 21301,
21302, 21311; 28 U.S.C. 2461, note; and 49 CFR 1.49.

0
2. Amend Sec.  225.19 by revising the first sentence of paragraph (c)
and revising paragraph (e) to read as follows:

Sec.  225.19  Primary groups of accidents/incidents.

* * * * *
    (c) Group II--Rail equipment. Rail equipment accidents/incidents
are collisions, derailments, fires, explosions, acts of God, and other
events involving the operation of on-track equipment (standing or
moving) that result in damages higher than the current reporting
threshold (i.e., $6,700 for calendar years 2002 through 2005, $7,700
for calendar year 2006, $8,200 for calendar year 2007, $8,500 for
calendar year 2008, $8,900 for calendar year 2009 and $9,200 for
calendar year 2010) to railroad on-track equipment, signals, tracks,
track structures, or roadbed, including labor costs and the costs for
acquiring new equipment and material. * * *
* * * * *
    (e) The reporting threshold is $6,700 for calendar years 2002
through 2005, $7,700 for calendar year 2006, $8,200 for calendar year
2007, $8,500 for calendar year 2008, $8,900 for calendar year 2009 and
$9,200 for calendar year 2010. The procedure for determining the
reporting threshold for calendar years 2006 and beyond appears as
paragraphs 1-8 of appendix B to part 225.
* * * * *

    Issued in Washington, DC, on December 4, 2009.
Joseph C. Szabo,
Administrator.
[FR Doc. E9-29476 Filed 12-9-09; 8:45 am]

BILLING CODE 4910-06-P


Comment Info: =================

General Comment:Dear Mr. Zeller:
             I am writing as a consumer of e-cigarettes to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.  I'm asking as a individual consumer of e-cigarettes for an extension for the comment period of the Proposed Rule  to be extended for an additional 105 days, from the current 75 days for a total of 180 days.
     This Proposed Rule brings up a number of issues and questions that are very important and relevant to me, and as a customer of e-cigarettes The Proposed Rule will have a significant impact on me.  In the Proposed Rule it asks many different questions I feel the need to respond, giving my thoughts and comments to many of these issues, but with my limited time to devote to the research and giving my thoughtful comments on these very important questions,  I find my time  is very limited.  I have already spent many hours reading, dissecting, trying to digest these issues, and they do take time to get threw.  I don't think its  unreasonable to extend the comment period 105 days for a total of 180 days for the public comment, considering it took many years for the FDA to come up with this rule, and this is the only opportunity for us consumers to provide our feedback for something that will highly effect our lives.
     I 100% believe e-cigarettes have saved my life, and feel very strongly in e-cigarettes as being a viable alternitive  to combustable cigarettes. In my comment I want to beable to provide my personal story, science and evidence-based responses to your many questions, so you at FDA can take my comment into serious  account.  I know that the FDA has the authority under 21 CFR 10.40  to extend the time frame of the comment period, and has done this in the past on many occasions. I ask you to exercise your authority for this very important issue, so all the shareholders will have the opportunity to have time to submit well informed comments on this proposed regulations.

Thank you for your time and consideration of my request.