Attachment N: February 16, 2011 Notice “Regulatory Review of Existing DOT Regulations” (76 FR 8940)

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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Proposed Rules

• Mail: Docket Management Facility;
U.S. Department of Transportation, 1200
Office of the Secretary
New Jersey Avenue, SE., Washington,
DC 20590–0001. If you submit
14 CFR Chapters I, II, III
comments by mail and would like to
know that they reached the facility,
23 CFR Chapters I, II, III
please enclose a stamped, self-addressed
envelope or postcard.
46 CFR Chapter II
• Hand Delivery or Courier: West
Building, Ground Floor, Room W12–
48 CFR Chapter 12
140, 1200 New Jersey Avenue, SE.,
Washington, DC between 9 a.m. and
49 CFR Chapters I, II, III and V, VI, VII,
5 p.m. ET., Monday through Friday,
VIII, X, XI
except Federal holidays.
• Fax: 202–493–2251.
[Docket No. DOT–OST–2011–0025]
To avoid duplication, please use only
Regulatory Review of Existing DOT
one of these four methods. All
Regulations
comments received will be posted
without change to http://
AGENCY: Office of the Secretary of
www.regulations.gov and will include
Transportation (OST), DOT.
any personal information you provide.
ACTION: Notice and request for
Docket: To read background
comments.
documents or comments received, go to
http://www.regulations.gov and click on
SUMMARY: In accordance with Executive
Order 13563, ‘‘Improving Regulation and the ‘‘read comments’’ box in the upper
right hand side of the screen. Then, in
Regulatory Review,’’ the Department of
the ‘‘Keyword’’ box insert ‘‘OST–2011–
Transportation (Department or DOT) is
0025’’ and click ‘‘Search.’’ Next, click the
conducting a review of its existing
‘‘Open Docket Folder’’ in the ‘‘Actions’’
regulations to evaluate their continued
validity and determine whether they are column. Finally, in the ‘‘Title’’ column,
click on the document you would like
crafted effectively to solve current
to review. If you do not have access to
problems. As part of this review, the
the Internet, you may view the docket
Department invites the public to
online by visiting the Docket
participate in a comment process
designed to help the Department ensure Management Facility in Room W12–140
on the ground floor of the Department
that it has a plan for periodically
of Transportation West Building, 1200
analyzing existing significant rules to
New Jersey Avenue, SE., Washington,
determine whether they should be
DC 20590, between 9 a.m. and 5 p.m.,
modified, streamlined, expanded, or
repealed and identify specific rules that Monday through Friday, except Federal
holidays.
may be outmoded, ineffective,
insufficient, or excessively burdensome. FOR FURTHER INFORMATION CONTACT: Neil
R. Eisner, Assistant General Counsel for
The Department also will hold a public
Regulation and Enforcement,
meeting to discuss and consider
Department of Transportation, 1200
comments from members of the public.
DATES: Comments should be received on New Jersey Avenue, SE., Washington,
DC 20590; (202) 366–4723. E-mail:
or before April 1, 2011. Late-filed
neil.eisner@dot.gov.
comments will be considered to the
extent practicable. In addition, the
SUPPLEMENTARY INFORMATION:
Department will hold a public meeting
Executive Order 13563
beginning at 9:30 a.m. ET on March 14,
2011, at the DOT headquarters, to
On January 18, 2011, President
discuss the regulatory review and take
Obama issued Executive Order 13563,
public comments. Commenters wishing which outlined a plan to improve
to have time allocated to them at the
regulation and regulatory review (76 FR
public meeting should submit initial
3821, 1/21/11). Executive Order 13563
comments by March 3, 2011, and clearly reaffirms and builds upon governing
indicate their desire to have time
principles of contemporary regulatory
allocated at the public meeting.
review, including Executive Order
12866, ‘‘Regulatory Planning and
ADDRESSES: You may submit comments
to Docket DOT–OST–2011–0025 by any Review,’’ (58 FR 51735, 10/4/1993), by
requiring Federal agencies to design
of the following methods:
cost-effective, evidence-based
• Federal eRulemaking Portal: Go to
regulations that are compatible with
http://www.regulations.gov and follow
economic growth, job creation, and
the instructions for sending your
competitiveness. The President’s plan
comments electronically.

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DEPARTMENT OF TRANSPORTATION

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recognizes that these principles should
not only guide the Federal government’s
approach to new regulation, but to
existing ones as well. To that end,
Executive Order 13563 requires agencies
to review existing significant rules to
determine if they are outmoded,
ineffective, insufficient, or excessively
burdensome.
To facilitate this review, Executive
Order 13563 requires each agency to
develop and submit to the Office of
Management and Budget’s Office of
Information and Regulatory Affairs a
preliminary plan for retrospectively
analyzing existing rules. Specifically,
the Department must provide a plan for
periodically reviewing existing
significant regulations to determine
whether any such regulations should be
modified, streamlined, expanded, or
repealed so as to make the Department’s
regulatory program more effective or
less burdensome in achieving the
Department’s regulatory objectives.
As Executive Order 13563 reaffirms,
the regulatory process must be
transparent and provide opportunities
for public participation. The
Department particularly believes, given
its broad regulatory responsibility, this
participation should extend to the
Department’s obligations under the
Executive Order to conduct a
retrospective review of existing
regulations. This review will be more
meaningful if it involves input from
those affected by the Department’s
regulations.
DOT’s Regulatory Responsibility
The mission of the Department is to
serve the United States by ensuring a
safe, fast, efficient, accessible, and
convenient transportation system that
meets our vital national interests and
enhances the quality of life of the
American people, today and into the
future. The Department carries out its
mission through the Office of the
Secretary (OST) and the following
operating administrations (OAs):
Federal Aviation Administration (FAA);
Federal Highway Administration
(FHWA); Federal Motor Carrier Safety
Administration (FMCSA); Federal
Railroad Administration (FRA); Federal
Transit Administration (FTA); Maritime
Administration (MARAD); National
Highway Traffic Safety Administration
(NHTSA); Pipeline and Hazardous
Materials Safety Administration

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(PHMSA); Research and Innovative
Technology Administration (RITA); and
St. Lawrence Seaway Development
Corporation (SLSDC). Although the
Surface Transportation Board (STB) is a
component of DOT, it is
organizationally independent and, as a
result, the Department does not have
responsibility for the STB’s regulatory
agenda.
DOT has statutory responsibility for a
wide range of regulations. For example,
DOT regulates safety in the aviation,
motor carrier, railroad, motor vehicle,
commercial space, and pipeline
transportation areas. DOT regulates
aviation consumer and economic issues,
and provides financial assistance and
writes the necessary implementing rules
for programs involving highways,
airports, mass transit, the maritime
industry, railroads, and motor
transportation and vehicle safety. It
writes regulations carrying out such
disparate statutes as the Americans with
Disabilities Act and the Uniform Time
Act. Finally, DOT has responsibility for
developing policies that implement a
wide range of regulations that govern
programs such as acquisition and grants
management, access for people with
disabilities, environmental protection,
energy conservation, information
technology, occupational safety and
health, property asset management,
seismic safety, security, and the use of
aircraft and vehicles.
DOT’s Existing Process for Reviewing
Rules
The Department has long recognized
that there should be no more regulations
than necessary and those that are issued
should be simple, comprehensible, and
impose as little burden as necessary.
Likewise, the Department understands
that review and revision of existing
regulations is essential to ensure that
they continue to meet the needs for
which they originally were designed
and remain cost-effective and costjustified. The Department regularly
makes a conscientious effort to review
its rules in accordance with the
Department’s 1979 Regulatory Policies
and Procedures (44 FR 11034, 2/26/
1979), Executive Order 12866, and
section 610 of the Regulatory Flexibility
Act.
The Department follows a repeating
10-year plan for the review of our
existing regulations, which is set forth
in our semi-annual Regulatory Agenda
published in the Federal Register (see
Appendix D to ‘‘Department Regulatory
Agenda; Semiannual Summary’’
published on December 20, 2010 (75 FR
79812)). The reviews conducted under
this plan comply with section 610 of the

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Regulatory Flexibility Act. OST and
most OAs have also elected to use this
repeating 10-year plan to comply with
the review requirements of the
Department’s Regulatory Policies and
Procedures and Executive Order 12866.
Generally, the agencies have divided
their rules into 10 different groups and
analyze one group each year, then start
over again. We regularly invite public
participation in those reviews and seek
general suggestions on rules that should
be revised or revoked. In the fall
Regulatory Agenda, we publish
information on the results of the
examinations completed during the
previous year. We are now engaged in
our second 10-year review.
The FAA, in addition to following a
10-year review plan in accordance with
section 610 of the Regulatory Flexibility
Act, has established a triennial process
to comply with other review
requirements. The FAA’s latest notice
was published November 15, 2007 (72
FR 64170). NHTSA conducts an
evaluation of both the costs and benefits
of each of its significant rules
approximately 4 years after the effective
date on which 100 percent of the annual
production of all types of vehicles
subject to the rule must comply with the
rule. This interval is necessary to ensure
that sufficient crash data are available
for the agency to determine whether a
statistically significant reduction in
crashes, injuries, and fatalities has
occurred. Other OAs also conduct
periodic public reviews to focus on
specific issues or to obtain comments on
rulemaking priorities. Moreover, under
49 CFR part 5, anyone may petition the
Department for rulemaking or for an
amendment or exemption to a rule.
As part of implementing Executive
Order 13563, we will assess our current
processes for reviewing rules and
examine whether our approach should
be modified going forward. While the
Department may use these existing
processes as significant inputs into its
preliminary plan, the Department
strongly encourages all parties affected
by DOT regulations to comment on
opportunities to improve our current
review processes in a manner that best
addresses the principles outlined in
Executive Order 13563.
Public Participation and Request for
Comments
DOT is an active regulatory agency
with broad regulatory responsibilities. A
robust regulatory program being
essential to our mission, it is all the
more important that we maintain a
consistent culture of retrospective
review and analysis. Thus, to
implement Executive Order 13563, the

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Department solicits the views of the
public on the following matters.
The public is first asked to comment
on how the Department should devise a
preliminary plan, with a defined
method and schedule, for identifying
certain significant rules that may be
obsolete, unnecessary, unjustified,
excessively burdensome, or
counterproductive. Comments might
address how best to evaluate and
analyze regulations in order to expand
on those that work and to modify,
improve, or rescind those that do not.
Comments might usefully address how
the Department can best obtain and
consider accurate, objective information
and data about the costs, burdens, and
benefits of existing regulations and
whether there are existing sources of
data that the Department can use to
evaluate the post-promulgation effects
of regulations over time. The
Department is particularly interested in
the public’s views about how well its
current processes for reviewing
regulations function and how those
processes might be expanded or
otherwise adapted to meet the objectives
of Executive Order 13563. The
Department is further interested in
comments about factors that the
Department should consider in setting
priorities and selecting rules for review.
Our initial selection criteria for these
rules are currently based on the factors
listed below, on which we seek public
comment.
The Department intends for its
preliminary plan to include an initial
list of candidate rules for review. The
Department solicits suggestions for
specific rules that should be on that list.
In nominating candidate rules for this
list, commenters might usefully address,
among other things, opportunities to use
the Department’s review process to
achieve the following objectives:
(1) Promote economic growth,
innovation, competitiveness, and job
creation; (2) eliminate outdated
regulations; (3) lessen the burdens
imposed on those directly or indirectly
affected by our regulations, increase the
benefits provided to the public by our
regulations, and improve the costbenefit balance of our regulations; (4)
lessen burdens imposed on small
entities; (5) eliminate duplicative or
overlapping regulations; (6) reduce
paperwork by eliminating duplication,
lessening frequency, allowing electronic
submission, standardizing forms,
exempting small entities, or other
means; (7) eliminate conflicts and
inconsistencies in the Department’s
regulations and those of its own
agencies or other Federal agencies or
state, local, or tribal governmental

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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Proposed Rules

bodies; (8) simplify or clarify language
in regulations; (9) revise regulations to
address changes in technology,
economic conditions, or other factors;
(10) determine if matters in an existing
regulation could be better handled fully
by the states without Federal
regulations; (11) reduce burdens by
incorporating international or industry
consensus standards into regulations;
(12) reconsider regulations that were
based on scientific or other information
that has been discredited or superseded;
and (13) expand regulations that are
insufficient to address their intended
objectives or to obtain additional
benefits.
Comments should focus on
regulations that have demonstrated
deficiencies. Comments that rehash
debates over recently issued rules will
be less useful. Particularly where
comments relate to a rule’s costs or
benefits, comments will be most useful
if there are data and experience under
the rule available to ascertain the rule’s
actual impact. For that reason, we
encourage the public to emphasize those
rules that have been in effect for a
sufficient amount of time to warrant a
fair evaluation. Furthermore, the public
should focus on rule changes that will
achieve a broad public impact, rather
than an individual personal or corporate
benefit. Where feasible, comments
should reference a specific regulation,
by Code of Federal Regulations (CFR)
cite, and provide the Department
information on what needs fixing and
why. Comments do not necessarily need
to address how to fix the perceived
problem, though such comments are
welcome. Lastly, we also want to stress
that this review is for existing rules; the
public should not use this process to
submit comments on proposed rules.
The public meeting will begin with a
discussion of and taking comments on
the Department’s preliminary plan for
regulatory review required by Executive
Order 13563. After that, we plan to
allow for comments on candidate rules
for review. The Department’s General
Counsel will preside over the meeting.
Other senior officials from the
Department and its OAs will also
attend. It is our intent that the public
meeting will provide an opportunity for
these officials to interact with
individuals or stakeholder
representatives. To enable them to
effectively participate in the public
meeting, they will need some
information in advance. As a result, we
are establishing the following process.
1. Suggestions for Discussion at
Public Meeting:
a. By March 3, 2011, the Department
requests that commenters submit their

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suggestions for discussion at the public
meeting and indicate whether they want
time allocated to them at the public
meeting. Commenters are welcome to
indicate how much time they would
like to be allocated, but the Department
reserves the right to allocate time as
necessary to ensure that as many
commenters as possible may participate
in the public meeting in a meaningful
manner.
b. The initial comments from those
intending to participate in the public
meeting should contain enough details
to permit DOT officials to sufficiently
prepare and ask questions.
c. The initial comments may be
augmented anytime before the end of
the full comment period.
d. Anyone who needs auxiliary aids
and services, such as sign language
interpreters, to effectively participate in
the meeting should contact the
Department via the ‘‘FOR FURTHER
INFORMATION CONTACT’’ information
provided above.
2. Public Meeting:
a. After receiving this initial round of
public comment, the Department will
organize those suggestions by topic and
OA for discussion during the public
meeting.
b. By having the public meeting after
receiving initial public comment and by
organizing the discussion around topics
and OAs, the Department will be better
positioned to discuss issues regarding a
particular rule, broad category of rules,
or affected group or industry, rather
than merely recording public comment
for later review.
c. The Department will hold its public
meeting beginning at 9:30 a.m. ET on
March 14, 2011 at the Department of
Transportation, West Building, Ground
Floor, DOT Conference Center,
Oklahoma Room, 1200 New Jersey
Avenue, SE., Washington, DC. We will
make a meeting outline available on
http://regs.dot.gov in advance of the
meeting. Furthermore, we are exploring
the use of technology to enable remote
participation in the meeting. We will
update http://regs.dot.gov with
information about opportunities for the
public to participate remotely.
3. Other Written Comments:
The Department will continue to
accept written comments through April
1, 2011. Those who do not wish to
attend the public meeting may, of
course, submit comments at any time
during the comment period.
4. Follow-up Action by DOT:
a. We will place a transcript or
summary of the public meeting in our
public docket (http://
www.regulations.gov) as soon as
possible after the end of the meeting.

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We note that because the docket is
Internet accessible, it should allow
those with Internet access to review
those proceedings as well as other
comments. We hope this will further
improve the interchange of ideas.
b. This review will provide
meaningful and significant input to the
Secretary, the General Counsel, OA
Administrators, and other DOT senior
officials. As soon as possible, depending
on the number of comments we receive
and the issues raised, the Department
will publish a report providing at least
a brief response to the comments we
have received, including a description
of any further action we intend to take.
Regulatory Notices
Privacy Act: Anyone may search the
electronic form of 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 http://www.gpoaccess.gov/fr/
browse.html and browse under 2000 for
April 11, looking under Department of
Transportation.
Authority: 5 U.S.C. 610; E.O. 13563, 76 FR
3821, Jan. 21 2011; E.O. 12866, 58 FR 51735,
Oct. 4, 1993.
Issued on February 10, 2011, in
Washington, DC.
Robert S. Rivkin,
General Counsel.
[FR Doc. 2011–3492 Filed 2–11–11; 8:45 am]
BILLING CODE 4910–9X–P

CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1700
[CPSC Docket No. CPSC–2011–0007]

Poison Prevention Packaging
Requirements; Proposed Exemption of
Powder Formulations of Colesevelam
Hydrochloride and Sevelamer
Carbonate
Consumer Product Safety
Commission.
ACTION: Proposed rule.
AGENCY:

The Consumer Product Safety
Commission (‘‘CPSC,’’ ‘‘Commission,’’ or
‘‘we’’) is proposing to amend its childresistant packaging requirements to
exempt powder formulations of two oral
prescription drugs, colesevelam
hydrochloride and sevelamer carbonate.
Colesevelam hydrochloride, currently

SUMMARY:

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