[Federal Register Volume 84, Number 103 (Wednesday, May 29, 2019)]
[Proposed Rules]
[Pages 24735-24741]
[FR Doc No: 2019-11088]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 218

[Docket No. FRA-2014-0033, Notice No. 4]
RIN 2130-AC48

Train Crew Staffing

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

ACTION: Notice of proposed rulemaking (NPRM); withdrawal.

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SUMMARY: FRA withdraws the March 15, 2016 NPRM concerning train crew
staffing. In withdrawing the NPRM, FRA is providing notice of its
affirmative decision that no regulation of train crew staffing is
necessary or appropriate for railroad operations to be conducted safely
at this time.

DATES: As of May 29, 2019, the NPRM published on March 15, 2016 (81 FR
13918), is withdrawn.

FOR FURTHER INFORMATION CONTACT: Alan H. Nagler, Senior Attorney, U.S.
Department of Transportation, Federal Railroad Administration, Office
of Chief Counsel, Room W31-309, 1200 New Jersey Avenue SE, Washington,
DC 20590,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents for Supplementary Information

I. Background
    A. Comments Generally Supporting the Proposed Rule
    B. Comments Generally Opposing the Proposed Rule
II. FRA's Decision
    A. There Is No Direct Safety Connection Between Train Crew
Staffing and the Lac-M[eacute]gantic or Casselton Accidents
    B. Rail Safety Data Does Not Support a Train Crew Staffing
Rulemaking
    C. Comments to the NPRM Do Not Support a Train Crew Staffing
Rulemaking
    D. A Train Crew Staffing Rule Would Unnecessarily Impede the
Future of Rail Innovation and Automation
    E. FRA's Withdrawal Is an Affirmative Decision Not To Regulate
With the Intention To Preempt State Laws

I. Background

    FRA has the authority to regulate train crew staffing pursuant to
its broad authority to, ``as necessary, . . . prescribe regulations and
issue orders for every area of railroad safety supplementing laws and
regulations in effect on October 16, 1970.'' \1\ On March 15, 2016, FRA
issued an NPRM which proposed regulations establishing minimum
requirements for the size of train crew staffs depending on the type of
operation (referred to herein as train crew staffing). The proposed
rule was not statutorily mandated, but rather, arose out of two rail
accidents in 2013 (Lac-M[eacute]gantic, Quebec and Casselton, North
Dakota).\2\ Following the Lac-M[eacute]gantic and Casselton accidents,
the rail industry, Transportation Safety Board of Canada (TSB of
Canada), and DOT undertook a variety of investigations and actions \3\
to address rail safety and hazardous materials issues highlighted by
those accidents, including FRA's submission of a task to the Railroad
Safety Advisory Committee (RSAC).\4\
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    \1\ 49 U.S.C. 20103; 49 CFR 1.89.
    \2\ The accidents are described in the NPRM. See 81 FR 13918,
13921-13924 (Mar. 15, 2016).
    \3\ Some of those actions are described in the NPRM. See, e.g.,
81 FR at 13922 (Mar. 15, 2016).
    \4\ To adopt a participatory approach to rulemaking, in 1996,
FRA first established the RSAC, which is designed to bring together
all segments of the rail community to provide advice and
recommendations to FRA on railroad safety issues. The RSAC includes
representatives from railroads, labor, shippers, industry
associations, and other government agencies. The RSAC provides
recommendations to FRA on issuing and updating regulations and
identifies non-regulatory approaches to improve safety. The most
recent RSAC meeting occurred on April 24, 2019.
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    On August 29, 2013, RSAC accepted a task (No. 13-05) entitled
``Appropriate Train Crew Size'' and formed a Working Group. The task
statement noted that in light of the Lac-M[eacute]gantic accident,
``FRA believes it is appropriate to review whether train crew staffing
practices affect railroad safety.'' Because FRA did not have reliable
or conclusive statistical data to suggest whether one-person crew
operations are safer or less safe than multiple-person crew operations,
FRA hoped that RSAC would provide useful analysis, including conclusive
data addressing whether there is a safety benefit or detriment from
crew redundancy (i.e., multiple-person train crews) and a report on the
costs and benefits associated with crew redundancy.

    Despite meeting five times from October 2013 to March 2014, the
RSAC Working Group was unable to reach consensus on any recommendation
or identify conclusive, statistical data to suggest whether there is a
safety benefit or detriment from crew redundancy. As noted in the NPRM,
the accident data railroads provided did not capture accidents where
the cause or contributing factor was a lack of a second crewmember and
thus that data did not aid the Working Group.
    Although RSAC was unable to identify data necessary to determine
whether a regulation was needed to address train crew staffing, FRA
believed it was important to give the broader public an opportunity to
provide input on this issue. Accordingly, on March 15, 2016, FRA issued
the NPRM with an initial 60-day comment period. FRA then extended the
comment period for an additional month \5\ and held a public hearing on
July 15, 2016. Subsequently, FRA extended the comment period through
August 15, 2016.\6\
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    \5\ 81 FR 30229 (May 16, 2016).
    \6\ 81 FR 39014 (June 15, 2016).
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    FRA received nearly 1,600 comments on the NPRM from industry
stakeholders and individuals, including current, former, and retired
crewmembers. FRA also received comments from the National
Transportation Safety Board (NTSB), two members of Congress, and
numerous state and local government officials. A general summary of the
comments is provided below.\7\
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    \7\ The order the comments are discussed in this document,
whether by issue or by commenter, is not intended to reflect the
significance of the comment raised or the standing of the commenter.
Additionally, this summary of the comments is intended to provide
both a general understanding of the overall extent and nature of the
comments, as well as give some specific descriptions to provide
context. Not every comment is described in this summary though all
were thoughtfully considered and, when specific numbers of comments
are identified by comment theme or issue, such numbers are
approximate as some comments could not be easily grouped with
others.
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A. Comments Generally Supporting the Proposed Rule

    Approximately 1,545 of the written comments were in support of some
kind of train crew staffing requirements, although not necessarily the
exact proposed requirements found in the NPRM. Two railroad employee
unions, the Brotherhood of Locomotive Engineers and Trainmen (BLET) and
the International Association of Sheet Metal, Air, Rail and
Transportation Workers Transportation Division (SMART TD), submitted
comments advocating for changes to the proposed rule. Commenters
supportive of the rule commonly sought more stringent requirements that
would mandate fewer, or no, exceptions to a two-person train crew, or
require the second person be a certified conductor under FRA's
requirements in 49 CFR part 242. The four central points of these
comments were that: (1) A train crew's duties are too demanding for one
person; (2) new technology will make the job more complex; (3)
unpredictable scheduling makes fatigue a greater factor when there is
only a one-person crew; and (4) the idea of a one-person train crew is
seemingly in conflict with the statutory and regulatory requirements
for certification of both locomotive engineers and conductors.
    The vast majority of comments supporting crew staffing
requirements, approximately 1,418, were filed by members of the public
on behalf of themselves as individuals. Most of these individual
commenters identified themselves as current, former, or retired train
crewmembers. These commenters largely provided anecdotal information
supporting why they thought trains staffed with fewer than two persons
created unsafe conditions. For example, Mike Rankin, who also testified
at the public hearing, recalled that he was a conductor working with a
locomotive engineer and was able to ``cut'' (separate) a train in half
after a grade crossing accident. He stated that his actions likely
saved a teenager's life by allowing emergency first responders quick
access to the injured teenager though the grade crossing, and enabling
hospital treatment much faster than if only one train crewmember had
been present and the crossing remained blocked.
    A variety of governmental officials and organizations also
indicated support for train crew staffing requirements, but with a
greater focus on safety for the communities in proximity to railroad
tracks, as opposed to the safety of the rail operation itself. For
example, FRA heard testimony at the public hearing from Mayor Karen
Darch of Barrington, Illinois. Mayor Darch explained that local
governments and railroads face the same task of determining appropriate
staffing levels, with the local governments focusing on police, fire,
and emergency medical services. She testified ``FRA should be concerned
that industry may be tempted to bet on its favorable accident odds and
make overly hasty staffing decisions to reduce operating costs.'' She
asked FRA to ``balance the interests of the public living or traveling
with proximity to'' railroad track, because the economies of
``villages, towns, and cities are negatively impacted on a daily basis
by train or grade crossing warning device malfunctions that block
crossings.'' FRA also heard testimony from Mr. Ronnie C. Harris,
Executive Director of the Louisiana Municipal Association, an
organization that represents 303 cities, towns, and villages, and two
consolidated parish governments in Louisiana. Mr. Harris expressed
concern about dangerous commodities being transported by rail on long
trains that have reached as long as 11,000 feet in length, and that,
without two crewmembers, any blocked crossings would remain blocked for
considerably longer than the time it would take a two-person crew to
unblock a crossing.\8\ In addition to these summarized comments, FRA
also received written comments generally supporting the NPRM's proposed
requirements from State and local governmental officials, agencies and
organizations from at least 16 States.
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    \8\ FRA is currently researching the rail operation safety
issues associated with freight train length, as well as
participating in a U.S. Government Accountability Office (GAO)
engagement (code 102557) on the same subject.
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    Two Members of Congress commented on the rule, and they echoed the
concerns of State and local governmental commenters, as well as the
labor unions. For instance, then-Senator Heidi Heitkamp (North Dakota)
testified at the public hearing that, as a representative of a State
that moves a lot of oil by rail, the people she represented are
concerned about safety and they want to know that their government is
doing everything possible from a regulatory standpoint to keep the
movement of oil and other hazardous materials safe. Senator Heitkamp
testified that she supports a crew staffing rule because she has heard
from rail workers in her State that believe having two crew members is
essential for their safety and the public's safety. Senator Heitkamp
further added that the NPRM provided the right balance as it proposed
to allow exceptions grounded in a safety rationale. Then-Rep. Richard
M. Nolan (8th District, Minnesota) also commented in support of the
rule. Like BLET and SMART TD, Rep. Nolan supported FRA adopting a more
stringent requirement that the second crewmember must be a certified
conductor.
    The Western Organization of Resource Councils (WORC), a regional
network of grassroots community organizations that includes 12,200
members, many of whom are farmers, ranchers, and others directly
affected by coal, oil, and gas development and who live in communities
along rail lines, raised

concerns with trains being operated with fewer than two crewmembers.
WORC commented that the 20-car hazardous materials threshold for ``key
trains'' is not stringent enough to adequately protect communities and
advocated for a single car threshold for determining whether a second
crewmember must be present.
    The Environmental Law & Policy Center, an organization dedicated to
the protection of the environment, commented that a second crewmember
can be critical in containing environmental damage or making
operational moves that could prevent accidents, and thus believes it is
common sense that two crewmembers are better than one.
    The National League of Cities (NLC), an advocate for more than
19,000 cities, villages, and towns, supported the NPRM. NLC commented
that local officials are concerned with the significant increase in the
volume of hazardous materials shipments combined with rail operators
seeking to reduce crew sizes. NLC supported the rule as a response to
``preventable tragedies of the past.''

B. Comments Generally Opposing the Proposed Rule

    Railroads, railroad associations, other associations and
organizations, and some individual commenters submitted approximately
39 comments that largely took the position that FRA should not regulate
train crew size for a variety of reasons. The Association of American
Railroads (AAR) commented that FRA's admission as to a lack of safety
data meant the rule was ``arbitrary,'' indicating that AAR believed the
rule could be determined unlawful through judicial review as a
challenge under the Administrative Procedure Act (APA). AAR supported
the NTSB's approach encouraging FRA to first modify its accident report
form to include the number of crewmembers in the controlling cab at the
time of an accident and then use the data it gathers to evaluate the
safety adequacy of current regulatory requirements.\9\ In addition, AAR
noted that the crew staffing issue has historically been left for labor
relations and that one-person train crews are currently being used
safely. Further, AAR also believed that: (1) The accidents FRA relied
on in the NPRM as the basis for the proposed rule did not provide such
a basis; (2) FRA massively underestimated the costs of the rule on the
industry; and (3) FRA's proposed rule was stifling innovation just as
autonomous technologies were emerging and DOT was removing roadblocks
to automation in other modes of transportation. AAR also provided
research documents to support its position. For instance, AAR funded
two studies conducted by Oliver Wyman, a consulting firm. One study,
``Analysis of North American Freight Rail Single-Person Crews: Safety
and Economics,'' concluded that safety data analyses show single-person
crew operations appear as safe as multiple-person crew operations, if
not safer. This study also concluded that the proposed rule would
greatly reduce U.S. railroads' ability to control operating costs,
without making the industry safer. A second study, ``Assessment of
European Railways: Characteristics and Crew-Related Safety,'' critiqued
several of the assertions FRA made in its Regulatory Impact Analysis
(RIA) on the NPRM, and generally found that European rail operations
are comparable to U.S. rail operations and therefore the success of the
European network in implementing single-person crew operations can
serve as a model for the U.S. rail system. AAR also submitted a
comparative risk assessment completed by ICF Incorporated, a consulting
firm, titled ``Evaluation of Single Crew Risks,'' which compared
traditional Class I railroad two-person crew mainline operations with
an FRA-compliant positive train control (PTC) system installed for both
one-person- and two-person-crew mainline operations to determine the
frequency of accidents that might be impacted by crew size. That
assessment found almost no difference in accident rates between one-
and two-person operations where PTC has been fully implemented. Union
Pacific Railroad and Norfolk Southern Railway were two of the Class I
freight railroads represented by AAR that submitted extensive comments
raising the same themes.
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    \9\ The NTSB's comment on the NPRM stated that the NTSB had not
taken a prior position on crew size but that its accident report
investigation into the derailment of National Railroad Passenger
Corporation (Amtrak) train no. 188 in Philadelphia, Pennsylvania, on
May 12, 2015, would address the issue. In that report, issued on May
17, 2016, the NTSB made a finding that FRA's ``accident database is
inadequate for comparing relevant accident rates based on crew size
because the information about accident circumstances and number of
crewmembers in the controlling cab is insufficient.'' NTSB, RAR-16/
02, Derailment of Amtrak Passenger Train 188 at 19 (2016).
Therefore, the NTSB made new recommendations to FRA to capture
crewmember data and use the data to evaluate the adequacy of current
crew size regulations. Id. (citing recommendations R-16-33 and R-16-
34). On April 25, 2018, FRA asked RSAC to consider forming a working
group to meet and discuss possible changes and updates to FRA's data
collection requirements that would include the NTSB's
recommendations and RSAC accepted that task. That process is
ongoing.
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    The American Short Line and Regional Railroad Association (ASLRRA)
objected to the NPRM for several reasons. ASLRRA was concerned about
the financial impact and paperwork burden the rule would have on short
line railroads, which generally are small entities, and questioned
whether FRA adequately followed existing legal requirements that
protect small businesses. ASLRRA challenged FRA's lack of data and
FRA's internal survey of its regional personnel to determine the extent
of one-person crew operations. Also, ASLRRA commented that its members
would have a competitive disadvantage compared to the trucking
industry, if the NPRM was finalized, and it submitted an economic paper
suggesting the proposed rule's requirements may induce railroads to
reallocate scarce resources away from upgrades to track and equipment.

II. FRA's Decision

    While FRA continues to monitor the potential safety impact of train
crew staffing, for the reasons provided below, FRA finds that no
regulation of train crew staffing is necessary or appropriate at this
time. FRA believes that current safety programs and actions taken
following the Lac-M[eacute]gantic and Casselton accidents are the
appropriate avenues for addressing those accidents. Moreover, despite
studying this issue in-depth and performing extensive outreach to
industry stakeholders and the general public, FRA's statement in the
NPRM that it ``cannot provide reliable or conclusive statistical data
to suggest whether one-person crew operations are generally safer or
less safe than multiple-person crew operations'' still holds true
today. Accordingly, FRA withdraws the NPRM.

A. There Is No Direct Safety Connection Between Train Crew Staffing and
the Lac-M[eacute]gantic or Casselton Accidents

    Although the Lac-M[eacute]gantic and Casselton accidents initially
led FRA to review the potential impact of train crew staffing on
safety, FRA subsequently determined that no direct conclusions could be
drawn about train crew staffing's safety impact on those accidents. As
FRA acknowledged in the NPRM, the TSB of Canada's investigation report
on the Lac-M[eacute]gantic accident concluded it would have been
possible for a single operator to apply a sufficient number of hand
brakes within a reasonable amount of time to have secured the train
involved in that

accident.\10\ The NPRM summarized TSB of Canada's finding that it could
not be concluded that a one-person crew contributed to the accident,
and that risk, if any, posed by a one-person crew was not determined to
have directly led to the accident. Simply put, TSB of Canada found no
direct causal connection between this catastrophic accident and the
number of train crewmembers.\11\ As FRA acknowledged in the NPRM, ``FRA
does not have information that suggests that there have been any
previous accidents involving one-person crew operations that could have
been avoided by adding a second crewmember.'' \12\ That fact remains
true today.
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    \10\ 81 FR at 13921.
    \11\ Railway Investigation Report R13D0054 at 117-18 (July 6,
2013), http://bit.ly/VLqVBk.
    \12\ 81 FR at 13921.
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    While the NPRM noted some indirect connections between crew
staffing and railroad safety with respect to the Lac-M[eacute]gantic
and Casselton accidents, those connections are tangential at best and
do not provide a sufficient basis for FRA regulation of train crew
staffing requirements. For example, TSB of Canada made indirect
connections in the Lac-M[eacute]gantic accident between the railroad's
poor safety culture and the one train crewmember's alleged failure to
properly secure the train. However, in making this connection, TSB of
Canada emphasized that a single crewmember could have prevented or
helped avoid the catastrophic accident by following the railroad's rule
requiring a proper hand brake effectiveness test (i.e., to determine
whether a sufficient number of hand brakes were applied to properly
secure the train), and that the incident may have been just as likely
with multiple train crewmembers and a poor safety culture.
    Likewise, after reviewing the facts of the Casselton accident as
described in the NPRM,\13\ and FRA's final accident investigation
report,\14\ FRA believes that the same type of positive post-accident
mitigating actions were achievable with: (1) Fewer than two crewmembers
on the BNSF grain train involved in the accident, and (2) a well-
planned, post-accident protocol that quickly brings railroad employees
to the scene of an accident.\15\ In other words, the facts of the
accident suggest that BNSF could have duplicated the mitigating moves
of the grain train crew with responding emergency crewmembers. While
FRA acknowledges the BNSF key train crew performed well, potentially
saving each other's lives, it is possible that one properly trained
crewmember, technology, and/or additional railroad emergency planning
could have achieved similar mitigating actions. Thus, the indirect
safety connections cited in the NPRM do not provide a sufficient basis
for FRA regulation of train crew staffing.
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    \13\ 81 FR at 13923-24.
    \14\ https://www.fra.dot.gov/eLib/details/L18586#p1_z50_gD_lAC_y2013.
    \15\ BNSF's post-accident actions included the development of an
inventory of emergency response resources along crude oil train
routes, identifying locations for staging emergency response
equipment, and identifying contacts for community notification.
NTSB/Railroad Accident Brief RAB-17/01 at 15-16, https://www.ntsb.gov/investigations/AccidentReports/Reports/RAB1701.pdf.
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    FRA's current safety programs and actions taken by FRA and DOT
following the Lac-M[eacute]gantic and Casselton accidents appropriately
address safety concerns raised by those accidents. In direct response
to the Lac-M[eacute]gantic derailment, FRA has taken the following
actions to ensure the safe transportation of products by rail in the
United States, with a particular focus on certain hazardous materials
that present an immediate danger for communities and the environment in
the event of a train accident.
     FRA issued Emergency Order (E.O.) 28 to address the
immediate dangers that arise from unattended equipment left unsecured
on mainline tracks.\16\ E.O. 28 was rescinded on the effective date of
a subsequent final rule,\17\ discussed further below.
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    \16\ See 78 FR 48218, Aug. 7, 2013.
    \17\ See Securement of Unattended Equipment, 80 FR 47349, 47358,
Aug. 6, 2015.
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     FRA and the Pipeline and Hazardous Materials Safety
Administration (PHMSA) jointly issued a Safety Advisory to railroads
and commodity shippers detailing eight recommended actions the industry
should take to better ensure the safe transport of hazardous
materials.\18\ These recommendations include: Reviewing the details and
lessons learned from the Lac M[eacute]gantic accident; reviewing crew
staffing levels; removing and securing the train's ``reverser'' when
unattended; reviewing all railroad operating procedures and testing/
operating rules related to securing a train; reviewing Transport
Canada's directives to secure and safely operate a train; and
conducting a system-wide assessment of security risks when a train is
unattended and identifying mitigation efforts for those risks.
Additionally, the Safety Advisory recommends testing and sampling of
crude oil for proper classification for shipment, as well as a review
of all shippers' safety and security plans.
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    \18\ See Federal Railroad Administration Safety Advisory 2013-
06, Lac-M[eacute]gantic Railroad Accident and DOT Safety
Recommendations, 78 FR 48224, Aug. 7, 2013, available at http://www.fra.dot.gov/eLib/details/L04720.
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     FRA and PHMSA jointly issued a follow-up Safety
Advisory.\19\ In this Safety Advisory, PHMSA and FRA reinforced the
importance of proper characterization, classification, and selection of
a packing group for Class 3 materials, and the corresponding
requirements in the federal hazardous materials regulations for safety
and security planning. In addition, the Safety Advisory reinforced that
FRA expects offerors by rail and rail carriers to revise their safety
and security plans required by the federal hazardous materials
regulations, including the required risk assessments, to address the
safety and security issues identified in FRA's E.O. 28 and the August
7, 2013, joint Safety Advisory.
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    \19\ See Federal Railroad Administration Safety Advisory 2013-
07, Safety and Security Plans for Class 3 Hazardous Materials
Transported by Rail, 78 FR 69745, Nov. 20, 2013, available at
https://www.fra.dot.gov/eLib/details/L04861.
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     FRA and PHMSA jointly issued a Safety Advisory
specifically regarding the transportation of petroleum crude oil.\20\
More specifically, the Safety Advisory recommends that offerors and
carriers of Bakken crude oil by rail tank car select and use the
railroad tank car designs with the highest level of integrity
reasonably available within their fleet for shipment of these hazardous
materials by rail in interstate commerce. Further, the Safety Advisory
recommends offerors and carriers of Bakken crude oil avoid the use of
older, legacy DOT Specification 111 or CTC 111 tank cars for the
shipment of such oil, to the extent reasonably practicable.
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    \20\ See Federal Railroad Administration Safety Advisory 2014-
01, Notice of Safety Advisory, 79 FR 27370, May 13, 2014, available
at https://www.fra.dot.gov/eLib/details/L05222.
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     FRA coordinated with PHMSA on a PHMSA final rule adopting
new operational requirements for certain trains transporting large
quantities of flammable liquids known as ``high-hazard flammable
trains''; enhancing safety improvements in tank car design standards;
providing a sampling and classification program for unrefined
petroleum-based products; and mandating notification requirements.\21\
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    \21\ See Hazardous Materials: Enhanced Tank Car Standards and
Operational Controls for High Hazard Flammable Trains, 80 FR 26643,
May 8, 2015.
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     FRA issued a final rule to strengthen existing securement
regulations, which mitigate risks associated with the unintended

movement of unattended equipment.\22\ Additional requirements addressed
hazards identified from the Lac-M[eacute]gantic accident. The final
rule codified much of FRA's E.O. 28, requiring railroads to implement
procedures to ensure the proper securement of equipment containing
certain types and amounts of hazardous materials when left unattended.
For example, the rule contains requirements to ensure that each
locomotive left unattended outside of a yard is equipped with an
operative exterior locking mechanism and that such locks be applied on
the controlling locomotive cab door when a train is transporting tank
cars loaded with certain hazardous materials. The rule also provides
that such hazardous materials trains may only be left unattended on a
main track or siding if justified in a plan adopted by the railroad,
accompanied by an appropriate job briefing, and proper securement is
made and verified. This rule also requires additional verification of
securement if a non-railroad emergency responder may have been in a
position to have affected the equipment.
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    \22\ See Securement of Unattended Equipment, 80 FR 47349, Aug.
6, 2015.
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    In addition to those actions, FRA previously addressed post-
accident protocols for passenger trains through the passenger train
emergency preparedness regulation.\23\ That rule, typically referred to
as the passenger train ``e-prep'' rule, requires each railroad involved
in passenger train operations to submit a plan, for FRA approval, that
ensures the railroad can effectively and efficiently manage passenger
train emergencies. The e-prep rule does not require a specific number
of on-board personnel, but rather ensures that railroads can
successfully implement the emergency preparedness plans and those
operations adopted under the rule; this notice of withdrawal does not
have any effect on the emergency preparedness plan requirements.
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    \23\ 49 CFR part 239, Passenger Train Emergency Preparedness; 63
FR 24630 (May 4, 1998).
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    As identified in the NPRM, FRA is also in the process of developing
regulations requiring Class I railroads, other freight railroads with
inadequate safety performance, and all passenger railroads to implement
safety risk reduction programs (RRPs).\24\ These RRPs represent a
comprehensive, system-oriented approach to safety that determines an
operation's level of risk by identifying and analyzing applicable
hazards and developing strategies to mitigate that risk. As part of its
RRP, a railroad would identify safety hazards and risks associated with
its operations, which could include changes in train crew staffing.\25\
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    \24\ On August 12, 2016, FRA published a final rule, found at 49
CFR part 270, mandating that commuter and intercity passenger
railroads develop and implement a system safety program to improve
the safety of their operations. 81 FR 53850. A stay was issued on
this final rule until September 4, 2019, to consider petitions for
reconsideration. 83 FR 63106. (Dec. 7, 2018). Similarly, on February
27, 2015, FRA published an NPRM that proposes to require each Class
I railroad and any freight railroad with inadequate safety
performance develop and implement an RRP to improve the safety of
their operations. 80 FR 10950.
    \25\ For example, FRA's proposed risk reduction rule would
require, if made final, that a railroad's safety performance
evaluation monitors the railroad's system to identify emerging or
new risks, which is expected to include a reduction in crew staffing
levels. See proposed 49 CFR 271.105, 80 FR at 10992-93. FRA's system
safety final rule requires that once FRA approves a railroad's plan,
the railroad must apply a risk-based hazard analysis to identify
hazards such as ``employee levels and schedules'' and must also
perform a new analysis whenever there are ``significant operational
changes.'' 49 CFR 270.103(q)(1) and (3).
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    In particular, as new technologies are introduced that may be
connected to future reductions in crew size (e.g., PTC technology),
railroads will be required to analyze the safety impacts of
implementing those technologies as part of their RRPs. As provided in
49 CFR part 270 and proposed in 49 CFR part 271,\26\ railroads required
to have an RRP shall conduct a technology analysis evaluating current,
new, or novel technologies that may mitigate or eliminate hazards and
the resulting risks identified through the risk-based hazard management
program. The technology analysis must also analyze the safety impact of
implementing the identified technologies.
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    \26\ See 49 CFR part 270.103 and proposed 49 CFR 271.109, 80 FR
at 10993.
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B. Rail Safety Data Does Not Support a Train Crew Staffing Rulemaking

    FRA's accident/incident safety data \27\ does not establish that
one-person operations are less safe than multi-person train crews.
Indeed, as FRA noted in the NPRM, existing one-person operations ``have
not yet raised serious safety concerns'' and, in fact, ``it is possible
that one-person crews have contributed to the [railroads'] improving
safety record.'' \28\ The NTSB also concurs with that conclusion:
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    \27\ 49 CFR part 225, Railroad Accidents/Incidents: Reports
Classification, and Investigations.
    \28\ 81 FR at 13950 and 13932.

    [T]here is insufficient data to demonstrate that accidents are
avoided by having a second qualified person in the cab. In fact, the
NTSB has investigated numerous accidents in which both qualified
individuals in a two-person crew made mistakes and failed to avoid
an accident.\29\
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    \29\ NTSB, RAR-16/02, Derailment of Amtrak Passenger Train 188,
at 18 (2016).

    FRA reviewed accident/incident data over a seventeen-year period
ending in 2018 and could not determine that any of the accidents/
incidents involving a one-person crew would have been prevented by
having multiple crewmembers.\30\ Moreover, because ``FRA does not
capture data that would provide information regarding the total
operating mileage for one-person crew operations in the United States
(or even two-person operations), it is impossible for FRA to normalize
the data and be able to compare the accident/incident rate of one-
person operations to that of two-person train crew operations to see if
one-person operations appear safer or less safe.'' \31\
---------------------------------------------------------------------------

    \30\ FRA presented safety data to the RSAC covering nearly 12
years of railroad safety data between January 2002 and October 2013.
The data was developed by reviewing accident/incident reports
submitted to FRA. As stated in the NPRM, the ``accident/incident
reports involving one-person train crews . . . do not clearly help
determine that the accident/incident would have been prevented by
having multiple crewmembers.'' 81 FR at 13931. In a subsequent
review of the data through 2018, FRA again could not conclude that
any of the accidents/incidents involving a one-person crew would
have been prevented by having multiple crewmembers.
    \31\ 81 FR at 13931.
---------------------------------------------------------------------------

    For these reasons, this accident/incident data does not support a
train crew staffing regulation. Rather, the accident/incident data FRA
presented in the NPRM suggests that a railroad with a higher rate of
train accidents involving the transportation of hazardous materials
could find itself more likely to continue that trend, regardless of the
size of the crew, assuming the railroad takes no further action to
prevent such accidents from occurring.\32\
---------------------------------------------------------------------------

    \32\ 81 FR 13930-32.
---------------------------------------------------------------------------

    Without ``data to prove a direct correlation between higher rates
of safety and multiple person crews,'' \33\ FRA provided the Working
Group with five FRA-sponsored research reports,\34\

as well as one Transportation Research Board (TRB) conference report
that contained presentations from multiple research reports, before the
first meeting of the RSAC in October 2013. While these reports identify
safety issues that railroads should consider when evaluating any
reduction in the number of train crewmembers or a shift in
responsibilities among those crewmembers, the reports do not indicate
that one-person crew operations are less safe and therefore do not form
a sufficient basis for a final rule on crew staffing.
---------------------------------------------------------------------------

    \33\ 81 FR at 13919.
    \34\ The following is a list of the five research reports and
their location on FRA's website:
    (1) Cognitive and Collaborative Demands of Freight Conductor
Activities: Results and Implications of a Cognitive Task Analysis--
Human Factors in Railroad Operations, Final Report, dated July 2012,
DOT/FRA/ORD-12/13. The report was prepared and researched by the
John A. Volpe National Transportation Systems Center (Volpe Center).
http://www.fra.dot.gov/eLib/details/L04331.
    (2) Rail Industry Job Analysis: Passenger Conductor, Final
Report, dated Feb. 2013, DOT/FRA/ORD-13/07. The report was prepared
and researched by the Volpe Center. http://www.fra.dot.gov/eLib/details/L04321.
    (3) Fatigue Status in the U.S. Railroad Industry, Final Report,
dated Feb. 2013, DOT/FRA/ORD-13/06. www.fra.dot.gov/Elib/Document/2929. The report was prepared and researched by QinetiQ North
America and FRA's Office of Research and Development.
    (4) Technology Implications of a Cognitive Task Analysis for
Locomotive Engineers--Human Factors in Railroad Operations, Final
Report, dated Jan. 2009, DOT/FRA/ORD-09/03. The report was prepared
and researched by the Volpe Center. www.fra.dot.gov/Elib/Document/381.
    (5) Using Cognitive Task Analysis to Inform Issues in Human
Systems Integration in Railroad Operations--Human Factors in
Railroad Operations, Final Report, dated May 2013, DOT/FRA/ORD-13/
31. The report was prepared and researched by the Volpe Center.
http://www.fra.dot.gov/eLib/details/L04589.
---------------------------------------------------------------------------

C. Comments to the NPRM Do Not Support a Train Crew Staffing Rulemaking

    Based on its review and careful consideration of all the comments
to the NPRM, FRA has determined that no regulation of train crew
staffing is necessary or appropriate at this time. The comments do not
provide conclusive data suggesting that there have been any previous
accidents involving one-person crew operations that could have been
avoided by adding a second crewmember or that one-person crew
operations are less safe.
    While the comments note some indirect connections between crew
staffing and railroad safety, such as post-accident response or
handling of disabled trains, those indirect connections do not provide
a sufficient basis for FRA regulation of train crew staffing
requirements. Moreover, FRA believes the indirect safety connections
cited in the comments could be achieved with fewer than two crewmembers
with a well-planned, disabled-train/post-accident protocol that quickly
brings railroad employees to the scene of a disabled train or accident.
FRA expects railroads would consider these protocols as mitigation
options under their RRPs when evaluating any changes to train crew
staffing levels. Thus, FRA believes that its previously discussed
current safety programs, along with other actions taken by FRA and DOT,
more appropriately address the safety concerns raised by the
commenters.
    FRA also does not concur with commenters who assert that the idea
of a one-person train crew is seemingly in conflict with the statutory
and regulatory requirements for certification of both locomotive
engineers and conductors. There are no specific statutes or regulations
prohibiting a one-person train crew, nor is there a specific
requirement that would prohibit autonomous technology from operating a
locomotive or train in lieu of a certified locomotive engineer.
However, the NPRM identified several regulations that a railroad would
need to be cognizant of when adjusting its crew staffing levels, while
acknowledging that none of those regulations requires a minimum number
of crewmembers to achieve compliance.

D. A Train Crew Staffing Rule Would Unnecessarily Impede the Future of
Rail Innovation and Automation

    FRA's current regulatory regime is largely based on traditional or
``legacy'' equipment and systems \35\ that railroads are, in many
instances, moving away from. DOT has recognized that the integration of
technology and automation across our transportation system has the
potential to increase productivity, facilitate freight movement, create
new kinds of jobs, and, most importantly, improve safety significantly
by reducing accidents caused by human error.\36\ FRA's accident/
incident data for calendar year 2017 shows that railroads reported
1,710 train accidents not occurring at highway grade crossings, and the
most frequent of which, 38 percent of those accidents (650), were
attributable to human factor causes.\37\ The potential benefits of
automation will certainly bring new challenges, requiring active steps
to prepare for the future by engaging with new technologies to ensure
safety without hampering innovation.
---------------------------------------------------------------------------

    \35\ Notable exceptions are 49 CFR part 236, subparts H and I,
which contain FRA's standards for processor-based signal and train
control systems and positive train control regulations.
    \36\ DOT's ``Preparing for the Future of Transportation,''
Automated Vehicles 3.0 (Oct. 4, 2018).
    \37\ The other causes cited were track (27 percent),
miscellaneous (18 percent), motive power/equipment (14 percent), and
signal caused, all track types (3 percent). https://safetydata.fra.dot.gov/officeofsafety/default.aspx.
---------------------------------------------------------------------------

    DOT's approach to achieving safety improvements begins with a focus
on removing unnecessary barriers and issuing voluntary guidance, rather
than regulations that could stifle innovation. In furtherance of these
goals, on March 29, 2018, FRA published a request for information (RFI)
on the subject of automation in the railroad industry.\38\ The RFI's
purpose was to facilitate comments that would help FRA understand the
current stage and development of automated railroad operations and how
the agency can best position itself to support the integration and
implementation of new automation technologies to increase the safety,
reliability, and capacity of the nation's railroad system. Some
commenters to the RFI identified the train crew staffing rulemaking as
a potential barrier to automation or other technology improvements.
Similar comments were submitted to the train crew staffing NPRM itself.
FRA generally agrees with those comments and, without sufficient safety
data showing the need for such a rule, concurs that the NPRM should be
withdrawn.
---------------------------------------------------------------------------

    \38\ 83 FR 13583.
---------------------------------------------------------------------------

    By requiring a minimum number of crewmembers for certain trains,
finalizing the train crew staffing rule would have departed from FRA's
long-standing regulatory approach of not endorsing any particular crew
staffing arrangement.\39\ FRA completely disagrees with the comments
suggesting that there is a specific statutory or regulatory requirement
that a certified locomotive engineer and a certified conductor are
required on each locomotive or train. The lack of a legal prohibition
means that each railroad is free to make train crew staffing decisions
as part of their operational management decisions, which would include
consideration of technological advancements and any applicable
collective bargaining agreements. However, the NPRM identified several
regulations that a railroad would need to be cognizant of when
adjusting its crew staffing levels, while acknowledging that none of
those regulations requires a minimum number of crewmembers to achieve
compliance. For example, the NPRM noted that when complying with the
requirements in 49 CFR 218.99 for performing a shoving or pushing
movement, a second crewmember routinely provides point protection.
However, the NPRM also noted that the point protection rule permits use
of cameras for performing these movements.\40\
---------------------------------------------------------------------------

    \39\ For example, FRA's conductor certification final rule
provides that: ``It is FRA's intent that this conductor
certification regulation . . . be neutral on the crew consist issue.
Nothing in part 242 should be read as FRA's endorsement of any
particular crew consist arrangement.'' 76 FR 69802, 69825 (Nov. 9,
2011).
    \40\ 81 FR at 13932 (citing 49 CFR 218.99).

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

E. FRA's Withdrawal Is an Affirmative Decision Not To Regulate With the
Intention To Preempt State Laws

    In issuing this withdrawal, FRA has determined that no regulation
of train crew staffing is necessary or appropriate at this time and
intends for the withdrawal to preempt all state laws attempting to
regulate train crew staffing in any manner. FRA believes that nine
states have laws in place regulating crew size in some manner:
California, West Virginia, and Wisconsin require a minimum of two crew
members for certain trains; \41\ Arizona, California, Ohio, and Oregon
have ``full crew'' requirements for certain trains; \42\ and
Massachusetts, New Jersey, and Washington impose other
restrictions.\43\ FRA also believes that laws regulating crew size have
been proposed in 30 states since 2015.\44\
---------------------------------------------------------------------------

    \41\ Cal. Lab. Code Sec.  6903(a); W. Va. Code Ann. Sec.  24-3-
1b(a); Wis. Stat. Ann. Sec.  192.25(2).
    \42\ Ariz. Rev. Stat. Ann. Sec.  40-881; Cal. Lab. Code Sec.
6901(a); Ohio Rev. Code Ann. Sec.  4999.06; Or. Rev. Stat. Ann.
Sec.  824.300.
    \43\ Mass. Gen. Laws Ann. ch. 160, Sec.  185; N.J. Stat. Ann.
Sec.  48:12-155; Wash. Rev. Code Ann. Sec.  81.40.010(1).
    \44\ 2016 Ala. S.B. 239; 2019 Ariz. H.B. 2102; 2019 Colo. H.B.
1034; 2019 Geor. H.B. 190; 2019 Idaho H.B. 53; 2019 Ill. S.B. 24;
2016 Ind. H.B. 1029; 2019 Iowa S.F. 248; 2015 Kan. S.B. 164; 2019
Ky. H.B. 111; 2016 La. H.B. 778; 2019 Maine H.P. 521; 2019 Md. H.B.
66; 2017 Mass. S.B. 1953; 2019 Minn. S.F. 263; 2019 Mo. H.B. 179;
2019 Neb. L.B. 611; 2017 Nev. S.B. 427; 2019 N.M. H.B. 244; 2015
N.Y. S.B. 7435; 2015 N.D. H.B. 1357; 2017 Ohio S.B. 74; 2017 Okla.
H.B. 1195; 2017 Pa. H.B. 1585; 2018 S.D. H.B. 1150; 2019 Tex. H.B.
742; 2019 Utah S.B. 176; 2018 Va. H.B. 1789; 2019 Wash. S.B. 5877;
2019 Wyo. H.B. 104.
---------------------------------------------------------------------------

    Provisions of the federal railroad safety statutes, specifically
the former Federal Railroad Safety Act of 1970 (FRSA), repealed and
recodified at 49 U.S.C. 20106, mandate that laws, regulations, and
orders ``related to railroad safety'' be nationally uniform.\45\ The
FRSA provides that a state law is preempted where FRA, under authority
delegated from the Secretary of Transportation, ``prescribes a
regulation or issues an order covering the subject matter of the State
requirement.'' \46\ A federal regulation or order covers the subject
matter of a state law where ``the federal regulations substantially
subsume the subject matter of the relevant state law.'' \47\ A federal
regulation or order need not be identical to the state law to cover the
same subject matter. The Supreme Court has held preemption can be found
from ``related safety regulations'' and ``the context of the overall
structure of the regulations.'' \48\ Federal and state actions cover
the same subject matter when they address the same railroad safety
concerns.\49\ FRA intends this notice of withdrawal to cover the same
subject matter as the state laws regulating crew size and therefore
expects it will have preemptive effect.
---------------------------------------------------------------------------

    \45\ 49 U.S.C. 20106(a)(1).
    \46\ 49 U.S.C. 20106(a)(2). While the FRSA also includes a
narrow savings clause for ``essentially local safety hazards'' which
might except an otherwise preempted state law, that clause would not
apply to the state laws at issue which would apply statewide and
therefore do not address an ``essentially local'' hazard. 49 U.S.C.
20106(a)(2); H.R. Rep. No. 1194, 91st Cong., 2d Sess. (1970)
(``these local hazards would not be statewide in character''); see
also Norfolk & Western Ry. Co. v. Public Utilities Com'n of Ohio,
926 F.2d 567, 571 (6th Cir. 1991) and National Ass'n of Regulatory
Util. Comm'rs v. Coleman, 542 F.2d 11, 13 (3d Cir. 1976) (both
holding that the local hazard exception cannot be applied to uphold
the application of a statewide rule).
    \47\ CSX Transportation, Inc. v. Easterwood, 507 U.S. 658, 664-
65 (1993).
    \48\ Easterwood, 507 U.S. at 674.
    \49\ Burlington Northern R.R. v. Montana, 880 F.2d 1104, 1105
(9th Cir. 1989).
---------------------------------------------------------------------------

    This notice of withdrawal provides what the Supreme Court referred
to as ``negative'' or ``implicit'' preemption. The Court recognized
that ``where failure of . . . federal officials affirmatively to
exercise their full authority takes on the character of a ruling that
no such regulation is appropriate or approved pursuant to the policy of
the statute,'' any state law enacting such a regulation is
preempted.\50\
---------------------------------------------------------------------------

    \50\ Ray v. Atlantic Richfield Co., 435 U.S. 151, 178 (1978)
(quoting Bethlehem Steel Co. v. New York State Labor Relations
Board, 330 U.S. 767, 774 (1947)). For example, FRA examined the
effectiveness of strobe and oscillating lights on locomotives and
concluded they were not effective in reducing grade-crossing
accidents and mandating them was therefore unjustified. 48 FR 20257
(May 5, 1983). When examined by the Ninth Circuit, the court held
that ``[u]nder [FRSA], where the FRA has rejected the requirement of
strobe or oscillating lights, a state may not require them.''
Marshall v. Burlington Northern, Inc., 720 F.2d 1149, 1154 (9th Cir.
1983).
---------------------------------------------------------------------------

    After closely examining the train crew staffing issue and
conducting significant outreach to industry and public stakeholders,
FRA determined that issuing any regulation requiring a minimum number
of train crewmembers would not be justified because such a regulation
is unnecessary for a railroad operation to be conducted safely at this
time. Thus, this notice of withdrawal provides FRA's determination that
no regulation of train crew staffing is appropriate and that FRA
intends to negatively preempt any state laws concerning that subject
matter.

    Issued in Washington, DC, under the authority set forth in 49
CFR 1.89(b).
Ronald L. Batory,
Administrator.
[FR Doc. 2019-11088 Filed 5-28-19; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Rules and Regulations]
[Pages 69586-69588]
[FR Doc No: 2010-28550]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 516

[Docket No. FDA-2010-N-0534]

New Animal Drugs for Minor Use and Minor Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations regarding new animal drugs for minor use and minor species
to update language and to clarify the regulations consistent with the
explanations in the preambles to the proposed and final rules
establishing them. This action is being taken to ensure accuracy and
clarity in the Agency's regulations.
    Elsewhere in this issue of the Federal Register, FDA is publishing
a companion proposed rule, under FDA's usual procedure for notice-and-
comment rulemaking, to provide a procedural framework to finalize the
rule in the event the Agency receives any significant adverse comments
and withdraws this direct final rule. The companion proposed rule and
direct final rule are substantively identical.

DATES: This rule is effective March 30, 2011. Submit either electronic
or written comments by January 31, 2011. If FDA receives no significant
adverse comments within the specified comment period, the Agency will
publish a document confirming the effective date of the final rule in
the Federal Register within 30 days after the comment period on this
direct final rule ends. If timely significant adverse comments are
received, the Agency will publish a document in the Federal Register
withdrawing this direct final rule before its effective date.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0534, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Meg Oeller, Center for Veterinary
Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Minor Use and Minor Species Animal Health Act of 2004 amended
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish
new regulatory procedures that provide incentives intended to make more
drugs legally available to veterinarians and animal owners for the
treatment of minor animal species and uncommon diseases in major animal
species. FDA published the final rule to implement these regulations
(part 516 (21 CFR part 516)) in the Federal Register of July 26, 2007
(72 FR 41010).
    FDA is issuing this direct final rule to amend its regulations
regarding new animal drugs for minor use and minor species (MUMS) in
part 516 to update language and clarify the intent of the regulations
consistent with the preambles to the proposed and final rules.
    In Sec.  516.3(b), FDA is amending the definition of ``Same dosage
form'' to make it clearer that the six dosage form categories listed in
the regulations under Sec.  516.3(b)(i) through (b)(vi) are the
``categories'' of dosage forms that the preamble to the proposed rule
referenced as follows: ``The second test of sameness which the statute
establishes to determine eligibility of an animal drug for designation
is `same dosage form.' The agency proposes to

use the long-established dosage form categories listed in Title 21 of
the Code of Federal Regulations to implement this statutory
requirement'' (70 FR 56394 at 56398, September 27, 2005). To accomplish
this clarification, the amendment will add the word ``categories''
after the phrase ``dosage forms'' and remove the ``s'' from ``forms''
in the first sentence of the definition.
    Section 516.20(b)(2) requires that requests for MUMS designation
include ``* * * the generic and trade name, if any, of the drug * * *''
intended to be designated and FDA is amending this language to replace
the terms ``generic'' and ``trade'' with the terms ``established'' and
``proprietary'', respectively, because the latter are the terms used in
the FD&C Act (see section 502(e) (21 U.S.C. 352(e)). FDA is also
revising this language to clarify that ``drug'' in the context of Sec.
516.20(b)(2) refers to the ``active pharmaceutical ingredient (API)''
name rather than to a formulated drug product name. The purpose of the
information required in this provision of the regulation is to permit
the Agency to determine whether a drug is eligible for designation on
the basis that it is not the ``same drug'' as a drug that is already
designated, conditionally approved, or approved (see section
573(a)(2)(B) of the FD&C Act (21 U.S.C. 360ccc-2)) and, because the
definition of ``same drug'' in Sec.  516.3(b) requires a knowledge of
the drug's ``active moiety'' in order to make this determination, a
request for MUMS designation needs to include the API name. This is
because the API name includes the active moiety and the drug product
name normally does not. FDA is also clarifying the relationship between
established and proprietary names in this context with the use of
parentheses.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. FDA is revising part 516 by updating language
and clarifying its intent. This rule is intended to make
noncontroversial changes to existing regulations. The Agency does not
anticipate receiving any significant adverse comment on this rule.
    Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule. The companion proposed rule provides the procedural
framework within which the rule may be finalized in the event the
direct final is withdrawn because of any significant adverse comment.
The comment period for this direct final rule runs concurrently with
the comment period of the companion proposed rule. Any comments
received in response to the companion proposed rule will also be
considered as comments regarding this direct rule.
    FDA is providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If FDA
receives any significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one that explains why the rule would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without a change. In
determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, we will consider whether the comment
raises an issue serious enough to warrant a substantive response in a
notice-and-comment process in accordance with section 553 of the
Administrative Procedure Act (5 U.S.C. 553). A comment recommending a
rule change in addition to this rule will not be considered a
significant adverse comment unless the comment also states why this
rule would be ineffective without the additional change.
    If FDA does not receive significant adverse comment, the Agency
will publish a document in the Federal Register confirming the
effective date of the final rule. The Agency intends to make the direct
final rule effective 30 days after publication of the confirmation
document in the Federal Register.
    A full description of FDA's policy on direct final rule procedures
may be found in a guidance document published in the Federal Register
of November 21, 1997 (62 FR 62466). The guidance document may be
accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

III. Legal Authority

    FDA's authority to issue this direct final rule is provided by
section 512(b)(1) of the FD&C Act (21 U.S.C. 360b(b)(1)). This section
states that any person may file with the Secretary of Health and Human
Services an application with respect to any intended use or uses of a
new animal drug and sets forth the specific information that must be
included in such an application. In addition, section 701(a) of the
FD&C Act (21 U.S.C. 371(a)) gives FDA general rulemaking authority to
issue regulations for the efficient enforcement of the FD&C Act. FDA is
issuing this direct final rule under these authorities.

IV. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this direct final rule would not impose any
compliance costs on the sponsors of animal drug products that are
currently marketed or in development, the Agency certifies that the
direct final rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
direct final rule to result in any 1-year expenditure that would meet
or exceed this amount.

VI. Federalism

    FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the direct final rule

does not contain policies that have substantial direct effects 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. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This direct final rule contains information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information addressed in the direct final
rule have been approved by OMB in accordance with the PRA under the
regulations governing designation of new animal drugs for MUMS (part
516, OMB control number 0910-0605). Thus, Sec.  516.20 as amended, does
not constitute a new or additional paperwork burden requiring OMB
approval.

VIII. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.

0
Therefore under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
516 is amended as follows:

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
1. The authority citation for 21 CFR part 516 continues to read as
follows:

    Authority:  21 U.S.C. 360ccc-1, 360ccc-2, 371.

0
2. Amend Sec.  516.3(b) by revising the introductory text of the
definition of ``Same dosage form'' to read as follows:

Sec.  516.3  Definitions.

* * * * *
    (b) * * *
    Same dosage form means the same as one of the dosage form
categories specified in the following parts of this chapter:
* * * * *

0
3. Amend Sec.  516.20 by revising paragraph (b)(2) to read as follows:

Sec.  516.20  Content and format of a request for MUMS-drug
designation.

* * * * *
    (b) * * *
    (2) The name and address of the sponsor; the name of the sponsor's
primary contact person and/or permanent-resident U.S. agent including
title, address, and telephone number; the established name (and
proprietary name, if any) of the active pharmaceutical ingredient of
the drug; and the name and address of the source of the active
pharmaceutical ingredient of the drug.
* * * * *

    Dated: November 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28550 Filed 11-12-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 158 (Thursday, August 15, 2013)]
[Rules and Regulations]
[Pages 49660-49662]
[FR Doc No: 2013-19649]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0262; Directorate Identifier 2013-NE-13-AD;
Amendment 39-17548; AD 2013-16-10]
RIN 2120-AA64

Airworthiness Directives; Hamilton Standard Division and Hamilton
Sundstrand Corporation Propellers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for
Hamilton Standard Division model 6/5500/F and 24PF and Hamilton
Sundstrand Corporation model 14RF, 14SF, 247F, and 568F series
propellers. This AD was prompted by the amount of corrosion detected
during major inspections (MI). This AD requires incorporating
inspections, based on a calendar time, into the propeller maintenance
schedule. We are issuing this AD to prevent corrosion that could result
in propeller failure and loss of airplane control.

DATES: This AD is effective September 19, 2013.

ADDRESSES: The Docket Operations office is located at Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001.
    For service information identified in this AD, contact Hamilton
Sundstrand Corporation, One Hamilton Road, Mail Stop 1A-3-C63, Windsor
Locks, CT 06096-1010; or Hamilton Standard Division, One Hamilton Road,
United Technologies Corporation, Mail Stop 1A-3-C63, Windsor Locks, CT
06096-1010; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: http://myhs.hamiltonsundstrand.com. You may view this service information at
the FAA, Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA 01803. 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 street address for
the Docket Office (phone:<PHONE_NUMBER>) is provided in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Michael Schwetz, Aerospace Engineer,
Boston Aircraft Certification Office, FAA, 12 New England Executive
Park, Burlington, MA 01803; 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 to include an AD that would apply to the specified products.
The NPRM published in the Federal Register on May 23, 2013 (78 FR
30795). The NPRM proposed to require incorporating inspections, based
on a calendar time, into the propeller maintenance schedule.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (78 FR 30795, May 23,
2013) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 30795, May 23, 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 30795, May 23, 2013).

Costs of Compliance

    We estimate that this AD affects about 1,044 propeller/hub
combinations installed on airplanes of U.S. registry. We also estimate
that it will take about 160 hours per propeller to perform one MI. The
average labor rate is $85 per hour. Based on these figures, we estimate
the cost of this AD on U.S. operators to be $14,198,400.

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 to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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):

2013-16-10 Hamilton Standard Division and Hamilton Sundstrand
Corporation: Amendment 39-17548; Docket No. FAA-2013-0262;
Directorate Identifier 2013-NE-13-AD.

(a) Effective Date

    This AD is effective September 19, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Hamilton Standard Division 6/5500/F and 24PF
and Hamilton Sundstrand Corporation 14RF, 14SF, 247F, and 568F
series propellers.

(d) Unsafe Condition

    This AD was prompted by the amount of corrosion detected during
major inspections

(MI). We are issuing this AD to prevent corrosion that could result
in propeller failure and loss of airplane control.

(e) Compliance

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

(f) MI for Blades and Hubs That Have an Updated Airworthiness
Limitations Section (ALS)

    For Hamilton Sundstrand Corporation propeller models 14RF-9,
14RF-21, 14SF-5, 14SF-7, 14SF-11E, and 568F-1, that have an approved
update to the ALS, within 45 days after the effective date of this
AD, perform an MI on the blades and hubs no later than seven years
after the date since installation (DSI). The DSI will begin at
initial installation after the most recent MI or initial
installation after production. Guidance on the inspections can be
found in the applicable Hamilton Sundstrand Corporation models/
manuals 14RF-9/P5186, revision 12, January 20, 2012; 14RF-21/P5189,
revision 8, February 20, 2013; 14SF-5/P5188, revision 10, dated
January 14, 2013; 14SF-7/P5185, revision 13, dated December 13,
2011; 14SF-11E/P5207, revision 2, dated June 28, 2012; and 568F-1/
P5206, revision 9, dated February 22, 2013.

(g) MI for Blades and Hubs That Do Not Have an Updated ALS

    For Hamilton Standard Division propeller models 6/5500/F and
24PF and Hamilton Sundstrand Corporation propeller models 14RF-19,
14RF-37, 14SF-11, 14SF-15, 14SF-23, 14SF-17, 14SF-19, 247F-1, 247F-
1E, 247F-3, 568F-1, 568F-5, and 568F-7, that do not have an approved
update to the ALS, within one year after the effective date of this
AD, perform an MI on the blades and hubs no later than seven years
after the DSI. The DSI will begin at initial installation after the
most recent MI or initial installation after production. Guidance on
the inspections can be found in the applicable Hamilton Standard
Division models/manuals 6/5500/F/P5190 and 24PF/61-12-01, and
Hamilton Sundstrand Corporation models/manuals 14RF-19/P5199, 14RF-
37/P5209, 14SF-11/P5196, 14SF-15/P5197, 14SF-23/P5197, 14SF-17/
P5198, 14SF-19/P5198, 247F-1/P4202, 247F-1E/P5204, 247F-3/P5205,
568F-1/P5214, 568F-5/P5203, and 568F-7/P5211.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Boston Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19
to make your request.

(i) Related Information

    (1) For more information about this AD, contact Michael Schwetz,
Aerospace Engineer, Boston Aircraft Certification Office, FAA, 12
New England Executive Park, Burlington, MA 01803; phone: 781-238-
7761; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Hamilton Sundstrand Corporation models/manuals 14RF-9/P5186,
revision 12, January 20, 2012; 14RF-21/P5189, revision 8, February
20, 2013; 14SF-5/P5188, revision 10, dated January 14, 2013; 14SF-7/
P5185, revision 13, dated December 13, 2011; 14SF-11E/P5207,
revision 2, dated June 28, 2012; and 568F-1/P5206, revision 9, dated
February 22, 2013, which are not incorporated by reference in this
AD, can be obtained from Hamilton Sundstrand Corporation, using the
contact information in paragraph (i)(3) of this AD.
    (3) For service information identified in the AD, contact
Hamilton Sundstrand Corporation, One Hamilton Road, Mail Stop 1A-3-
C63, Windsor Locks, CT 06096-1010; or Hamilton Standard Division,
United Technologies Corporation, One Hamilton Road, Mail Stop 1A-3-
C63, Windsor Locks, CT 06096-1010; phone:<PHONE_NUMBER>; fax: 860-
660-0372; email<EMAIL_ADDRESS>Internet: http://myhs.hamiltonsundstrand.com. You may view this service information
at the FAA, Engine & Propeller Directorate, 12 New England Executive
Park, Burlington, MA 01803. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

(j) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on August 2, 2013.
Carlos A. Pestana,
Acting Assistant Directorate Manager, Engine & Propeller Directorate,
Aircraft Certification Service.
[FR Doc. 2013-19649 Filed 8-9-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73653-73654]
[FR Doc No: 2012-29794]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 7910-006]

Milburnie Hydro Inc.; Notice of Termination of Exemption by
Implied Surrender and Soliciting Comments, Protests, and Motions To
Intervene

    Take notice that the following hydroelectric proceeding has been
initiated by the Commission:
    a. Type of Proceeding: Termination of exemption by implied
surrender.
    b. Project No.: 7910-006.
    c. Date Initiated: December 4, 2012.
    d. Exemptee: Milburnie Hydro Inc.
    e. Name and Location of Project: The Milburnie Hydroelectric
Project is located on Neuse River in Wake County, North Carolina.
    f. Filed Pursuant to: 18 CFR 4.106.
    g. Exemptee Contact Information: Mr. Michael Allen, President,
Milburnie Hydro, P.O. Box 1401, Burlington, NC 27216-1401.
    h. FERC Contact: Krista Sakallaris<PHONE_NUMBER> or
<EMAIL_ADDRESS>    i. Deadline for filing comments, protests, and motions to intervene
is 30 days from the issuance date of this notice. Please file your
submittal electronically via the Internet (eFiling) in lieu of paper.
Please refer to the instructions on the Commission's Web site under
http://www.ferc.gov/docs-filing/efiling.asp and filing instructions in
the Commission's Regulations at 18 CFR section 385.2001(a)(1)(iii).\1\
To assist you with eFilings you should refer to the submission
guidelines document at http://www.ferc.gov/help/submission-guide/user-guide.pdf. In addition, certain filing requirements have statutory or
regulatory formatting and other instructions. You should refer to a
list of these ``qualified documents'' at http://www.ferc.gov/docs-filing/efiling/filing.pdf. You must include your name and contact
information at the end of your comments. Please include the project
number (P-7910-006) on any documents or motions filed. The Commission
strongly encourages electronic filings; otherwise, you should submit an
original and seven copies of its submittal to the following address:
The Secretary, Federal Energy Regulatory Commission, Mail Code: DHAC,
PJ-12, 888 First Street NE., Washington, DC 20426.
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    \1\ http://www.ferc.gov/legal/fed-sta.asp Select the link for
Code of Federal Regulations and navigate to Sec.  385.2001.
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    j. Description of Existing Facilities: The inoperative project
consists of the following existing facilities: (1) A 14-foot-high and
625-foot-long concrete dam; (2) a reservoir with an estimated storage
area of 500 acre-feet; (3) a powerhouse with a total installed capacity
of 645 kW; (4) transmission lines; and (5) appurtenant facilities.
    k. Description of Proceeding: The exemptee is in violation of
Standard Article 1 of its exemption; which was granted on May 11, 1984
(27 FERC ] 62,132). The Commission's regulations, 18 CFR 4.106,
provides, among other things, that the Commission reserves the right to
revoke an exemption if any term or condition of the exemption is
violated. At some point between May 2006 and September 2009, vandals
stole wiring from the projects powerhouse, causing the project to
become inoperable.
    On October 21, 2009, August 21, 2012, and on November 16, 2012, the
Commission directed the exemptee to file a public safety plan and a
plan and schedule to restore operation to the project, or to surrender
the exemption. The Commission also informed the exemptee that it was in
violation of the terms and conditions of the exemption. The exemptee
has not attempted to restore project operation and has not responded to
the Commissions letters by filing the required plans.
    The Division of Dam Safety and Inspections accompanied by staff
from the U.S. Fish and Wildlife Service and the North Carolina
Department of Environment and Natural Resources inspected the project
in August 2012; neither the exemptee nor a representative for the
project attended the inspection. The exemptee has not properly
maintained the project and it remains inoperable. By not operating the
project as proposed and authorized, the exemptee is in violation of the
terms and conditions of the exemption.
    l. This notice is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street NE.,
Washington, DC 20426. The filing may also be viewed on the Commission's
Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the
Docket number (P-7910-006) excluding the last three digits in the
docket number field to access the notice. You may also register online
at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via

email of new filings and issuances related to this or other pending
projects. For assistance, call toll-free 1-866-208-3676 or email
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, and 385.214. In determining the appropriate action to take,
the Commission will consider all protests filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any protests or motions to
intervene must be received on or before the specified deadline date for
the particular proceeding.
    o. Filing and Service of Responsive Documents--Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE,'' as applicable; (2) set forth in the heading
the project number of the proceeding to which the filing responds; (3)
furnish the name, address, and telephone number of the person
commenting, protesting or intervening; and (4) otherwise comply with
the requirements of 18 CFR 385.2001 through 385.2005. All comments,
protests or motions to intervene must set forth their evidentiary basis
and otherwise comply with the requirements of 18 CFR 4.34(b). All
comments, protests, or motions to intervene should relate to project
works which are the subject of the termination of exemption. A copy of
any protest or motion to intervene must be served upon each
representative of the exemptee specified in item g above. If an
intervener files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency. A copy of all other filings in reference to
this notice must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described proceeding. If any agency does not
file comments within the time specified for filing comments, it will be
presumed to have no comments.

    Dated: December 4, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-29794 Filed 12-10-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Notices]
[Page 70974]
[FR Doc No: 2013-28425]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension:
    Rule 12d3-1, OMB Control No. 3235-0561, SEC File No. 270-504.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information summarized below. The Commission plans to
submit these existing collections of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Section 12(d)(3) of the Investment Company Act of 1940 (15 U.S.C.
80a) generally prohibits registered investment companies (``funds''),
and companies controlled by funds, from purchasing securities issued by
a registered investment adviser, broker, dealer, or underwriter
(``securities-related businesses''). Rule 12d3-1 (``Exemption of
acquisitions of securities issued by persons engaged in securities
related businesses'' (17 CFR 270.12d3-1)) permits a fund to invest up
to five percent of its assets in securities of an issuer deriving more
than fifteen percent of its gross revenues from securities-related
businesses, but a fund may not rely on rule 12d3-1 to acquire
securities of its own investment adviser or any affiliated person of
its own investment adviser.
    A fund may, however, rely on an exemption in rule 12d3-1 to acquire
securities issued by its subadvisers in circumstances in which the
subadviser would have little ability to take advantage of the fund,
because it is not in a position to direct the fund's securities
purchases. The exemption in rule 12d3-1(c)(3) is available if (i) the
subadviser is not, and is not an affiliated person of, an investment
adviser that provides advice with respect to the portion of the fund
that is acquiring the securities, and (ii) the advisory contracts of
the subadviser, and any subadviser that is advising the purchasing
portion of the fund, prohibit them from consulting with each other
concerning securities transactions of the fund, and limit their
responsibility in providing advice to providing advice with respect to
discrete portions of the fund's portfolio.
    Based on an analysis of fund filings, the staff estimates that
approximately 775 fund portfolios enter into subadvisory agreements
each year.\1\ Based on discussions with industry representatives, the
staff estimates that it will require approximately 3 attorney hours to
draft and execute additional clauses in new subadvisory contracts in
order for funds and subadvisers to be able to rely on the exemptions in
rule 12d3-1. Because these additional clauses are identical to the
clauses that a fund would need to insert in their subadvisory contracts
to rely on rules 10f-3, 17a-10, and 17e-1 and because we believe that
funds that use one such rule generally use all of these rules, we
apportion this 3 hour time burden equally to all four rules. Therefore,
we estimate that the burden allocated to rule 12d3-1 for this contract
change would be 0.75 hours.\2\ Assuming that all 775 funds that enter
into new subadvisory contracts each year make the modification to their
contract required by the rule, we estimate that the rule's contract
modification requirement will result in 581 burden hours annually.\3\
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    \1\ Based on information in Commission filings, we estimate that
44.4 percent of funds are advised by subadvisers.
    \2\ This estimate is based on the following calculation (3 hours
/ 4 rules = .75 hours).
    \3\ This estimate is based on the following calculation: (0.75
hours x 775 portfolios = 581 burden hours).
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    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Written comments are invited on: (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 collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: November 21, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-28425 Filed 11-26-13; 8:45 am]
BILLING CODE 8011-01-P