[Federal Register Volume 76, Number 85 (Tuesday, May 3, 2011)]
[Notices]
[Pages 24888-24889]
[FR Doc No: 2011-10618]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0044]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by June 2,
2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that the written comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk
Officer. Fax:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments should be identified with the OMB
control number 0910-0673. Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance: Information Request Regarding Guidance for
Industry and FDA Staff; Section 905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco Products--(OMB Control Number 0910-
0673)--Extension.
    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) by adding a new chapter granting
FDA important new authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors.
    Section 905(j)(1) of the FD&C Act authorizes FDA to establish the
form and manner for the submission of information related to
substantial equivalence (21 U.S.C. 387e(j)(1)). In a level 1 guidance
document issued under the Good Guidances Practices regulation (21 CFR
10.115), FDA provides recommendations intended to assist persons
submitting reports under section 905(j) of the FD&C Act, and explains,
among other things, FDA's interpretation of the statutory sections
related to substantial equivalence (see ``Guidance for Industry and FDA
Staff--Section 905(j) Reports: Demonstrating Substantial Equivalence
for Tobacco Products'' (January 6, 2011, 76 FR 789).)
    In the Federal Register of January 24, 2011 (76 FR 4116), FDA
published a 60-day notice requesting public comment on the proposed
information collection.
    FDA received one comment in response to the 60-day notice. The
commenter indicated that the substantial equivalence requirements were
``burdensome to industry in the extreme,'' that FDA's estimation of the
number of reports to be received was too low, and that the current
burden hours to complete each report was unrealistic. Although the
commenter asserted that the burden hours were too low and unrealistic,
no alternative estimates were provided.
    The recommendations in the ``Guidance for Industry and FDA Staff--
Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products'' are the information that FDA suggests a manufacturer
include in a report submitted under section 905(j)(1)(A)(i) of the FD&C
Act. The recommendations reflect the information FDA believes is
necessary for it to make the required findings under section 910(a) of
the FD&C Act (21 U.S.C. 387j(a)). FDA has also articulated current
enforcement policies in its guidances that are intended to address some
of the burden associated with premarket requirements for new tobacco
products (manufacturers and interested parties may refer to FDA's

Web site for guidance documents with current enforcement policies
related to premarket requirements for tobacco products (http://www.fda.gov/TobaccoProducts/default.htm)).
    With regard to the comment that the number of section
905(j)(1)(A)(i) substantial equivalence reports which FDA estimated to
be submitted (150 per year) was too low, FDA has revised its estimate
based on information it now has from initial submissions, interactions
with industry, and other information, such as the comment received on
the 60-day notice on the information collection. As shown below, FDA is
increasing the annual estimate of the number of reports received from
150 to 1,000.
    With regard to the comment that the number of hours to prepare and
submit each report is unrealistic, FDA continues to believe that the
currently estimated hours (360 hours annually) is appropriate,
particularly given that the premarket requirements for new tobacco
products (Section 910 of the FD&C Act) are new and manufacturers'
experience with preparing a submission is just beginning to develop. As
the requirements and program become more familiar to respondents, FDA
may be able to refine these estimates. In addition, as discussed
previously, the commenter did not suggest an alternative number of
hours. FDA's estimate of 360 hours reflects an amount of time that
should provide each submitter enough time to prepare and submit a
section 905(j)(1)(A)(i) substantial equivalence report to the Agency.

Estimation of Burden

    FDA estimates the burden for this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
        FD&C Act sections           respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
905(j)(a)(A)(i) and 910(a)......           1,000               1           1,000             360         360,000
    Total.......................  ..............  ..............  ..............  ..............         360,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA has based these estimates on information it now has available
from interactions with the industry, comments regarding the submission
of 905(j)(1)(A)(i) substantial equivalence reports, and comments on the
60-day information collection notice request for comments published in
the Federal Register on January 24, 2011 (76 FR 4116). Table 1 of this
document describes the annual reporting burden as a result of the
implementation of the substantial equivalence requirements of sections
905(j)(1)(A)(i) and 910(a) of the FD&C Act. FDA estimates that it will
receive 1,000 section 905(j) substantial equivalence reports each year
and that it will take a manufacturer approximately 360 hours to prepare
a report of substantial equivalence for a new tobacco product.
Therefore, FDA estimates the burden for submission of substantial
equivalence information will be 360,000 hours.

    Dated: April 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10618 Filed 5-2-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: July 22, 2008 (Volume 73, Number 141)]
[Notices]
[Page 42557-42558]
[DOCID:fr22jy08-32]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Project No. 13237-000]

Whitman River Dam, Inc.; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comment, Motions To Intervene, and
Competing Applications

July 11, 2008.
    On June 9, 2008, Whitman River Dam, Inc. filed an application,
pursuant to section 4(f) of the Federal Power Act, proposing to develop
the hydroelectric potential at the existing Crocker Dam located on the
Whitman River in the Town of Westminster, Worcester County,
Massachusetts.
    The proposed project would consist of: (1) An earthen and masonry
dam, 38.5-foot-high and 520-foot-long, (2) a head pond with storage of
1,027.0 acre-feet, (3) an existing 42-inch diameter steel penstock, and
(4) a new powerhouse located downstream of the dam on the left side of
the river containing one generating unit having a capacity of 100
kilowatts. The project would have an annual generation of 607,000
kilowatt hours and would be sold to power marketers, local industrial
users, or municipal electric utilities.
    Applicant Contact: Mr. Robert Francis, President, Whitman River
Dam, Inc., P.O. Box 145, 10 Tommy Francis Road, Westminster, MA 01473.
FERC Contact: Shameek Patel,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically

via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site under the ``e-Filing'' link. If unable to
be filed electronically, documents may be paper-filed. To paper-file,
an original and eight copies should be mailed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. For more information on how to submit these types
of filings please go to the Commission's Web site located at http://
www.ferc.gov/filing-comments.asp. More information about this project
can be viewed or printed on the ``eLibrary'' link of Commission's Web
site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket
number (P-13237) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

 Kimberly D. Bose,
 Secretary.
 [FR Doc. E8-16702 Filed 7-21-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Notices]
[Page 33431]
[DOCID:fr13jy09-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR09-16-000]

Tesoro Refining and Marketing Company Complainant v. SFPP L.P.,
Respondent; Notice of Complaint

July 2, 2009.
    Take notice that on June 30, 2009, Tesoro Refining and Marketing
Company (Tesoro) filed a formal complaint against SFPP L.P. (SFPP)
pursuant to Rule 206 of the Rules of Practice and Procedure of the
Federal Energy Regulatory Commission, 18 CFR 385.206; the Procedural
Rules Applicable to Oil Pipeline Proceedings, 18 CFR 343.2; sections
1(5), 8, 9, 13, 15 and 16 of the Interstate Commerce Act (ICA), 49
U.S.C. App. Sec. Sec.  1(5), 8, 9, 13, 15 and 16 (1984) and section
1803 of the Energy Policy Act of 1992 (EPAct).
    Tesoro alleges that SFPP has overstated its cost of service in the
2007 and 2008 Form 6 filed with the Commission. Tesoro requests that
the Commission determine that the cost of service methodology employed
by SFPP L.P. in the 2007 and 2008 From 6s improperly characterize
SFPP's cost of service, resulting in unjust and unreasonable rates,
thereby violating sections 1(4) and 1(5) of the ICA and section
343.2(c)(1) of the Commission's regulations.
    Tesoro certifies the copies of the complaint were served on the
contacts for SFPP as listed on the Commission's list of Corporate
Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions or protests must be filed on or before the
comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 20, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16434 Filed 7-10-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Rules and Regulations]
[Pages 21717-21719]
[FR Doc No: 2018-09958]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0964]
RIN 1625-AA00

Safety Zone; Oregon Inlet, Dare County, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is re-establishing and extending a temporary
final rule that creates a temporary safety zone on the waters of Oregon
in Dare County, NC. The duration of this safety zone is extended
through June 15, 2018. This safety zone is needed to protect personnel,
vessels, and the marine environment from the hazards associated with
installing the navigation span and will restrict vessel traffic from
the bridge's navigation span as it is under construction by preventing
vessel traffic on a portion of Oregon Inlet. Entry of vessels or
persons into this safety zone is prohibited.

DATES: This rule is effective without actual notice from May 10, 2018
until June 15, 2018. For the purposes of enforcement, actual notice
will be used from May 4, 2018, until May 10, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-0964 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Matthew Tyson, Waterways Management
Division, U.S. Coast Guard Sector North Carolina, Wilmington, NC;
telephone:<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port

II. Background Information and Regulatory History

    On October 10, 2017, the North Carolina Department of
Transportation notified the Coast Guard that they

would be installing the navigation span of the new Herbert C. Bonner
Bridge in Oregon Inlet, Dare County, North Carolina on January 29
through March 24, 2018, with alternate dates of March 25 through May 6,
2018. In response, following publication of an NPRM and solicitation of
public comments, on January 1, 2018, the Coast Guard published a final
rule establishing a temporary safety zone effective from January 29,
2018 through March 24, 2018, 83 FR 2910 with alternate dates of March
25, 2018 through May 6, 2018. Due to inclement weather and material
delays the project has been delayed and the project completion date has
been extended through June 15, 2018. The COTP North Carolina has
determined that potential safety hazards associated with the
construction will be a concern for anyone transiting the Oregon Inlet
navigation channel.
    The Coast Guard is issuing this temporary rule to re-establish and
extend the duration of the temporary safety zone without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because notification of the need to extend
the safety zone was not given to the Coast Guard until April 26, 2018.
It is impracticable and contrary to the public interest to publish an
NPRM because we must extend the safety zone immediately through June
15, 2018, to protect personnel, vessels, and the marine environment on
the navigable waters in Oregon Inlet during this construction phase.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is needed to protect persons, vessels, and the
marine environment on the navigable waters in Oregon Inlet during this
construction phase.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The COTP North Carolina has determined that potential safety
hazards associated with the construction will be a concern for anyone
transiting the Oregon Inlet navigation channel. The purpose of this
rule is to protect persons, vessels, and the marine environment on the
navigable waters in Oregon Inlet during this construction phase.

IV. Discussion of the Rule

    This rule re-establishes and extends the effective dates of the
rule, published in 83 FR 2910, by 40 days making it effective through
June 15, 2018. Construction is expected to take place on 33 separate
days during this construction period. The safety zone will be active
for two hours each day, with the exact times announced via Broadcast
Notices to Mariners at least 48 hours prior to enforcement. The safety
zone will include all navigable waters of Oregon Inlet from approximate
position 35[deg]46'23'' N, 75[deg]32'18'' W, thence southeast to
35[deg]46'18'' N, 75[deg]32'12'' W, thence southwest to 35[deg]46'16''
N, 75[deg]32'16'' W, thence northwest to 35[deg]46'20'' N,
75[deg]32'23'' W, thence northeast back to the point of origin, (NAD
1983). This zone is intended to protect persons, vessels, and the
marine environment on the navigable waters in Oregon Inlet during this
construction phase. No vessel or person will be permitted to enter the
safety zone during the designated times.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the proposed safety zone. Vessel traffic will
not be allowed to enter or transit a portion of Oregon Inlet during
specific two hour periods on 33 separate days from January 29 through
June 15, 2018. The specific two hour period for each work day will be
broadcasted at least 48 hours in advance and vessels will be able to
transit Oregon Inlet at all other times. The Coast Guard will issue a
Local Notice to Mariners and transmit a Broadcast Notice to Mariners
via VHF-FM marine channel 16 regarding the safety zone. This portion of
Oregon Inlet has been determined to be a medium to low traffic area at
this time of the year. This rule does not allow vessels to request
permission to enter the safety zone covering a portion of the Oregon
Inlet navigation channel during the designated times.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you

wish to comment on actions by employees of the Coast Guard, call 1-888-
REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against
small entities that question or complain about this rule or any policy
or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, which guides the Coast Guard in complying with the
National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and
have determined that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. This rule involves a safety zone lasting for two
hours on 33 separate days that would prohibit entry into a portion of
Oregon Inlet for bridge construction. It is categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T05-0964 to read as follows:

Sec.  165.T05-0964   Safety Zone; Oregon Inlet, Dare County, NC.

    (a) Location. The following area is a safety zone: All navigable
waters of Oregon Inlet, from approximate position 35[deg]46'23'' N,
75[deg]32'18'' W, thence southeast to 35[deg]46'18'' N, 75[deg]32'12''
W, thence southwest to 35[deg]46'16'' N, 75[deg]32'16'' W, thence
northwest to 35[deg]46'20'' N, 75[deg]32'23'' W, thence northeast back
to the point of origin (NAD 1983) in Dare County, NC.
    (b) Definitions. As used in this section--
    Captain of the Port means the Commander, Sector North Carolina.
    Construction crews means persons and vessels involved in support of
construction.
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard commissioned, warrant, or petty officer
designated by the Captain of the Port North Carolina (COTP) for the
enforcement of the safety zone.
    (c) Regulations. (1) The general regulations governing safety zones
in Sec.  165.23 apply to the area described in paragraph (a) of this
section.
    (2) With the exception of construction crews, entry into or
remaining in this safety zone is prohibited.
    (3) All vessels within this safety zone when this section becomes
effective must depart the zone immediately.
    (4) The Captain of the Port, North Carolina can be reached through
the Coast Guard Sector North Carolina Command Duty Officer, Wilmington,
North Carolina at telephone number<PHONE_NUMBER>.
    (5) The Coast Guard and designated security vessels enforcing the
safety zone can be contacted on VHF-FM marine band radio channel 13
(165.65 MHz) and channel 16 (156.8 MHz).
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the safety zone by Federal, State, and local
agencies.
    (e) Enforcement period. This regulation will be enforced from May 4
through June 15, 2018.
    (f) Public notification. The Coast Guard will notify the public of
the specific two hour closures at least 48 hours in advance by
transmitting Broadcast Notice to Mariners via VHF-FM marine channel 16.

    Dated: May 4, 2018.
Bion B. Stewart,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2018-09958 Filed 5-9-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10158-10159]
[FR Doc No: 2019-05083]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85298; File No. SR-BX-2019-003]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Exchange's Transaction Fees at Equity 7, Section 118(a)

March 13, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 1, 2019, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to to [sic] amend the Exchange's transaction
fees at Equity 7, Section 118(a), as described further below.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the Exchange's
transaction fees at Rule 7018(a) [sic] to adjust the qualifying terms
for an existing credit it offers to members with orders that access
liquidity on the Exchange.
    The Exchange operates on the ``taker-maker'' model, whereby it pays
credits to members that take liquidity and charges fees to members that
provide liquidity. Currently, the Exchange offers several different
credits for orders that access liquidity on the Exchange. Among these
credits, the Exchange offers a $0.0015 per share executed credit for
orders that access liquidity (excluding orders with Midpoint pegging
and excluding orders that receive price improvement and execute against
an order with a Non-displayed price) that are entered by a member that
accesses liquidity equal to or exceeding 0.065% of total Consolidated
Volume \3\ during a month. For this credit, the Exchange proposes to
increase the level of total Consolidated Volume required to qualify for
the credit from 0.065% to 0.075%. The Exchange proposes to recalibrate
the threshold upward to provide an incentive for firms to reach the
Consolidated Volume threshold necessary to qualify for the credit.
---------------------------------------------------------------------------

    \3\ Pursuant to Equity 7, Section 118(a), the term
``Consolidated Volume'' means the total consolidated volume reported
to all consolidated transaction reporting plans by all exchanges and
trade reporting facilities during a month in equity securities,
excluding executed orders with a size of less than one round lot.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\5\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \6\
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Likewise, in NetCoalition v. Securities and Exchange Commission \7\
(``NetCoalition'') the D.C. Circuit upheld the Commission's use of a
market-based approach in evaluating the fairness of market data fees
against a challenge claiming that Congress mandated a cost-based
approach.\8\ As the court emphasized, the Commission ``intended in
Regulation NMS that `market forces, rather than regulatory
requirements' play a role in determining the market data . . . to be
made available to investors and at what cost.'' \9\
---------------------------------------------------------------------------

    \7\ NetCoalition v. SEC, 615 F.3d 525 (DC Cir. 2010).
    \8\ See NetCoalition, at 534-535.
    \9\ Id. at 537.
---------------------------------------------------------------------------

    Further, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers' . . . .'' \10\ Although the court and
the SEC were discussing the cash equities markets, the Exchange
believes that these views apply with equal force to the options
markets.
---------------------------------------------------------------------------

    \10\ Id. at 539 (quoting Securities Exchange Act Release No.
59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008)
(SR-NYSEArca-2006-21)).
---------------------------------------------------------------------------

    The Exchange believes that it is reasonable to increase the
Consolidated Volume threshold for orders that access liquidity in
securities (excluding orders with Midpoint pegging and excluding orders
that receive price improvement and execute against an order with a Non-
displayed price) that are entered by a member that accesses liquidity
equal to or exceeding 0.065% of total Consolidated Volume during a
month from .065% to 0.075% of total Consolidated Volume. The proposal
is a modest increase in the standard, which will ensure that members
are providing adequate market participation in return for the credit.
    The Exchange believes that increase to the total Consolidated
Volume requirement is an equitable allocation and is not unfairly
discriminatory because the Exchange will apply the same credit to all
similarly situated members. Again, the proposed change is

a moderate increase to the Consolidated Volume requirement that any
member may choose to achieve if it wishes to receive the credit.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees and credits to remain competitive with other exchanges and
with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees and credits in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee or credit changes in this market may impose any burden on
competition is extremely limited.
    In this instance, the Exchange's proposed credit amendment does not
impose a burden on competition because the Exchange's execution
services are completely voluntary and subject to extensive competition
both from other exchanges and from off-exchange venues. The proposed
modification to the $0.0015 per share executed credit represents a
modest increase in the criteria required to qualify for the credit.
Members may choose to increase their level of Consolidated Volume to
qualify for the credit. If the proposal is unattractive to market
participants, it is likely that the Exchange will lose market share as
a result. Accordingly, the Exchange does not believe that the proposal
will impair the ability of members or competing order execution venues
to maintain their competitive standing in the financial markets.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\11\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2019-003 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2019-003. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2019-003 and should be submitted on
or before April 9, 2019.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-05083 Filed 3-18-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70220-70223]
[FR Doc No: 2011-29155]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2011-0294 (PDA-35(R)]

New Jersey Regulations on Transportation of Regulated Medical
Waste

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Public notice and invitation to comment.

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SUMMARY: Interested parties are invited to comment on an application by
the Healthcare Waste Institute (Institute) for an administrative
determination as to whether Federal hazardous material transportation
law preempts regulations of the New Jersey Department of Environmental
Protection (NJDEP) which apply to the transportation of regulated
medical waste in commerce, including the packaging of regulated medical
waste for transportation; marking and labeling of containers of
regulated medical waste offered for transportation or transported; the
description of regulated medical waste on documents accompanying
shipments of regulated medical waste and the use and retention of such
documents; and the marking of vehicles which transport regulated
medical waste.

DATES: Comments received on or before December 27, 2011 and rebuttal
comments received on or before February 8, 2012 will be considered
before an administrative determination is issued by PHMSA's Chief
Counsel. Rebuttal comments may discuss only those issues raised by
comments received during the initial comment period and may not discuss
new issues.

ADDRESSES: The Institute's application and all comments received may be
reviewed in the Docket Operations Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590. The application and all
comments are available on the U.S. Government Regulations.gov Web site:
http://www.regulations.gov.
    Comments must refer to Docket No. PHMSA-2011-0294 and may be

submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-(202) 493-2251.
     Mail: Docket Operations Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Docket Operations Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
    A copy of each comment must also be sent to (1) Alice P. Jacobson,
Esq., Director, Healthcare Waste Institute, 4301 Connecticut Avenue
NW., Suite 300, Washington, DC 20008, and (2) Mary Jo M. Aiello,
Administrator, New Jersey Department of Environmental Protection, Solid
and Hazardous Waste Management Program, Mail Code 401-02C, P.O. Box
420, Trenton, NJ 08625-0420. A certification that a copy has been sent
to these persons must also be included with the comment. (The following
format is suggested: ``I certify that copies of this comment have been
sent to Mses. Jacobson and Aiello at the addresses specified in the
Federal Register.'')
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing a comment 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.regulations.gov.
    A subject matter index of hazardous materials preemption cases,
including a listing of all inconsistency rulings and preemption
determinations, is available through PHMSA's home page at http://www.phmsa.dot.gov. From the home page, click on ``Hazmat Safety
Community,'' then on ``Regulations,'' then on ``Preemption Documents''
under ``Chief Counsel's Decisions.'' A paper copy of the index will be
provided at no cost upon request to Mr. Hilder, at the address and
telephone number set forth in FOR FURTHER INFORMATION CONTACT below.

FOR FURTHER INFORMATION CONTACT: Frazer C. Hilder, Office of Chief
Counsel (PHC-2), Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590; telephone No.<PHONE_NUMBER>;
facsimile No.<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Application for a Preemption Determination

    The Institute has applied to PHMSA for a determination whether
Federal hazardous material transportation law, 49 U.S.C. 5101 et seq.,
preempts requirements in Subchapter 3A of Title 7, Chapter 26 of the
New Jersey Administrative Code, on the transportation of regulated
medical waste in commerce regarding:
     Packaging regulated medical waste for transport off-site,
in Sections 7:26-3A.10 (segregation of sharps, fluids (greater than 20
cc), and ``other'' regulated medical waste); 7:26-3A-11 (``oversized''
regulated medical waste that is ``too large to be placed in a plastic
bag or standard container''); and 7:26-3A.27(g) (conditions when a
transporter must comply with ``pre-transport'' requirements).
     Labeling and marking containers of regulated medical waste
with additional information, in Sections 7:26-3A.14 and 7:26-3A.15,
respectively, and 7:26-3A.28(c) (additional labeling by a ``subsequent
transporter'' when ``regulated medical waste is handled by more than
one transporter'').
     Preparation, use, and retention of a ``tracking form''
describing a shipment of regulated medical waste, in Sections 7:26-
3A.19, 7:26-3A.21, 7:26-3A.28, 7:26-3A.31 through 7:26-3A.34, 7:26-
3A.41, and (with respect to rail transporters) 7:26-3A-45 & 7:26-
3A.46.\1\
---------------------------------------------------------------------------

    \1\ In its application, the Institute refers to Section 7:26-
3A.47 (``Alternative or innovative technology authorization''), but
it seems clear that it meant to refer to Section 7:26-3A.46 (``Rail
shipment tracking form requirements'').
---------------------------------------------------------------------------

     Preparation and retention of ``exception reports,'' in
Sections 7:26-3A.21, 7:26-3A.22, and 7:26-3A.36.
     Marking a motor vehicle used to transport regulated
medical waste with additional information, in Section 7:26-3A.30.
    In summary, the Institute contends that these requirements are
preempted because they are (1) not ``substantively the same as''
requirements in the Federal hazardous material transportation law or
the Hazardous Materials Regulations (HMR), 49 CFR parts 171-180, on the
transportation of regulated medical waste, or (2) otherwise an
``obstacle'' to accomplishing and carrying out Federal hazardous
material transportation law and the HMR, as the NJDEP requirements are
enforced and applied. The Institute notes that certain non-Federal
requirements on the transportation of medical waste have been found to
be preempted in Preemption Determination (PD) No. 23(RF),
``Morrisville, PA Requirements for Transportation of `Dangerous
Waste,''' 66 FR 37260 (July 17, 2001), decision on petition for
reconsideration, 67 FR 2948 (Jan. 22, 2002), and PD-29(R),
``Massachusetts Requirements on the Storage and Disposal of Infectious
or Physically Dangerous Medical or Biological Waste,'' 69 FR 34715
(June 22, 2004). As explained in those decisions, DOT regulates the
transportation of regulated medical waste as a Division 6.2 hazardous
material. PD-23(RF), 66 FR at 37260-61; PD-29(R), 69 FR at 34717.\2\
See also 49 CFR 173.134(a)(5).
---------------------------------------------------------------------------

    \2\ In 1991, after a two-year demonstration program, the U.S.
Environmental Protection Agency (EPA) decided not to regulate
medical waste, so that medical waste is not a ``hazardous waste''
under the Resource Conservation and Recovery Act, 42 U.S.C. 6901 et
seq. Id.
---------------------------------------------------------------------------

II. Federal Preemption

    Section 5125 of 49 U.S.C. contains express preemption provisions
relevant to this proceeding. As amended by Section 1711(b) of the
Homeland Security Act of 2002 (Pub. L. 107-296, 116 Stat. 2320), 49
U.S.C. 5125(a) provides that a requirement of a State, political
subdivision of a State, or Indian Tribe is preempted--unless the non-
Federal requirement is authorized by another Federal law or DOT grants
a waiver of preemption under Sec.  5125(e) --if

    (1) Complying with a requirement of the State, political
subdivision, or Tribe and a requirement of this chapter, a
regulation prescribed under this chapter, or a hazardous materials
transportation security regulation or directive issued by the
Secretary of Homeland Security is not possible; or
    (2) The requirement of the State, political subdivision, or
Tribe, as applied or enforced, is an obstacle to accomplishing and
carrying out this chapter, a regulation prescribed under this
chapter, or a hazardous materials transportation security regulation
or directive issued by the Secretary of Homeland Security.

    These two paragraphs set forth the ``dual compliance'' and
``obstacle'' criteria that PHMSA's predecessor agency, the Research and
Special Programs Administration, had applied in issuing inconsistency
rulings prior to 1990, under the original preemption provision in the
Hazardous Materials Transportation Act (HMTA). Public Law 93-633
112(a), 88 Stat. 2161 (1975). The dual compliance and obstacle criteria

are based on U.S. Supreme Court decisions on preemption. Hines v.
Davidowitz, 312 U.S. 52 (1941); Florida Lime & Avocado Growers, Inc. v.
Paul, 373 U.S. 132 (1963); Ray v. Atlantic Richfield, Inc., 435 U.S.
151 (1978).
    Subsection (b)(1) of 49 U.S.C. 5125 provides that a non-Federal
requirement concerning any of the following subjects is preempted--
unless authorized by another Federal law or DOT grants a waiver of
preemption--when the non-Federal requirement is not ``substantively the
same as'' a provision of Federal hazardous material transportation law,
a regulation prescribed under that law, or a hazardous materials
security regulation or directive issued by the Department of Homeland
Security:

    (A) The designation, description, and classification of
hazardous material.
    (B) The packing, repacking, handling, labeling, marking, and
placarding of hazardous material.
    (C) The preparation, execution, and use of shipping documents
related to hazardous material and requirements related to the
number, contents, and placement of those documents.
    (D) The written notification, recording, and reporting of the
unintentional release in transportation of hazardous material.
    (E) The designing, manufacturing, fabricating, inspecting,
marking, maintaining, reconditioning, repairing, or testing a
package, container, or packaging component that is represented,
marked, certified, or sold as qualified for use in transporting
hazardous material.\3\
---------------------------------------------------------------------------

    \3\ Subparagraph (E) was editorially revised in Sec. 7122(a) of
the Hazardous Materials Transportation Safety and Security
Reauthorization Act of 2005, which is Title VII of the Safe,
Accountable, Flexible, Efficient Transportation Equity Act: A Legacy
for Users (SAFETEA-LU), Public Law 109-59, 119. Stat. 1891 (Aug. 10,
2005). Technical corrections to cross-references in subsections (d),
(e), and (g) were made in Public Law 110-244, Sec. 302(b), 122 Stat.
1618 (June 6, 2008).

To be ``substantively the same,'' the non-Federal requirement must
conform ``in every significant respect to the Federal requirement.
Editorial and other similar de minimis changes are permitted.'' 49 CFR
107.202(d).\4\
---------------------------------------------------------------------------

    \4\ Additional standards apply to preemption of non-Federal
requirements on highway routes over which hazardous materials may or
may not be transported and fees related to transporting hazardous
material. See 49 U.S.C. 5125(c) and (f). See also 49 CFR 171.1(f)
which explains that a ``facility at which functions regulated under
the HMR are performed may be subject to applicable laws and
regulations of state and local governments and Indian tribes.''
---------------------------------------------------------------------------

    The 2002 amendments and 2005 reenactment of the preemption
provisions in 49 U.S.C. 5125 reaffirmed Congress's long-standing view
that a single body of uniform Federal regulations promotes safety
(including security) in the transportation of hazardous materials. More
than thirty years ago, when it was considering the HMTA, the Senate
Commerce Committee ``endorse[d] the principle of preemption in order to
preclude a multiplicity of State and local regulations and the
potential for varying as well as conflicting regulations in the area of
hazardous materials transportation.'' S. Rep. No. 1102, 93rd Cong. 2nd
Sess. 37 (1974). When Congress expanded the preemption provisions in
1990, it specifically found:

    (3) Many States and localities have enacted laws and regulations
which vary from Federal laws and regulations pertaining to the
transportation of hazardous materials, thereby creating the
potential for unreasonable hazards in other jurisdictions and
confounding shippers and carriers which attempt to comply with
multiple and conflicting registration, permitting, routing,
notification, and other regulatory requirements,
    (4) Because of the potential risks to life, property, and the
environment posed by unintentional releases of hazardous materials,
consistency in laws and regulations governing the transportation of
hazardous materials is necessary and desirable,
    (5) In order to achieve greater uniformity and to promote the
public health, welfare, and safety at all levels, Federal standards
for regulating the transportation of hazardous materials in
intrastate, interstate, and foreign commerce are necessary and
desirable.

Public Law 101-615 2, 104 Stat. 3244. (In 1994, Congress revised,
codified and enacted the HMTA ``without substantive change,'' at 49
U.S.C. chapter 51. Public Law 103-272, 108 Stat. 745 (July 5, 1994).) A
United States Court of Appeals has found uniformity was the
``linchpin'' in the design of the Federal laws governing the
transportation of hazardous materials. Colorado Pub. Util. Comm'n v.
Harmon, 951 F.2d 1571, 1575 (10th Cir. 1991).

III. Preemption Determinations

    Under 49 U.S.C. 5125(d)(1), any person (including a State,
political subdivision of a State, or Indian Tribe) directly affected by
a requirement of a State, political subdivision or Tribe may apply to
the Secretary of Transportation for a determination whether the
requirement is preempted. The Secretary of Transportation has delegated
authority to PHMSA to make determinations of preemption, except for
those concerning highway routing (which have been delegated to the
Federal Motor Carrier Safety Administration). 49 CFR 1.53(b).
    Section 5125(d)(1) requires notice of an application for a
preemption determination to be published in the Federal Register.
Following the receipt and consideration of written comments, PHMSA
publishes its determination in the Federal Register. See 49 CFR
107.209(c). A short period of time is allowed for filing of petitions
for reconsideration. 49 CFR 107.211. A petition for judicial review of
a final preemption determination must be filed in the United States
Court of Appeals for the District of Columbia or in the Court of
Appeals for the United States for the circuit in which the petitioner
resides or has its principal place of business, within 60 days after
the determination becomes final. 49 U.S.C. 5127(a).
    Preemption determinations do not address issues of preemption
arising under the Commerce Clause, the Fifth Amendment or other
provisions of the Constitution, or statutes other than the Federal
hazardous material transportation law unless it is necessary to do so
in order to determine whether a requirement is authorized by another
Federal law, or whether a fee is ``fair'' within the meaning of 49
U.S.C. 5125(f)(1). A State, local or Indian Tribe requirement is not
authorized by another Federal law merely because it is not preempted by
another Federal statute. Colorado Pub. Util. Comm'n v. Harmon, above,
951 F.2d at 1581 n.10.
    In making preemption determinations under 49 U.S.C. 5125(d), PHMSA
is guided by the principles and policies set forth in Executive Order
No. 13132, entitled ``Federalism'' (64 FR 43255 (Aug. 10, 1999)), and
the President's May 20, 2009 memorandum on ``Preemption'' (74 FR 24693
(May 22, 2009)). Section 4(a) of that Executive Order authorizes
preemption of State laws only when a statute contains an express
preemption provision, there is other clear evidence Congress intended
to preempt State law, or the exercise of State authority directly
conflicts with the exercise of Federal authority. The President's May
20, 2009 memorandum sets forth the policy ``that preemption of State
law by executive departments and agencies should be undertaken only
with full consideration of the legitimate prerogatives of the States
and with a sufficient legal basis for preemption.'' Section 5125
contains express preemption provisions, which PHMSA has implemented
through its regulations.

IV. Public Comments

    All comments should be directed to whether 49 U.S.C. 5125 preempts
the New Jersey regulations on the transportation of regulated medical
waste in commerce. Comments should specifically address the preemption
criteria discussed in Part II above.

    Issued in Washington, DC, on November 7, 2011.
Vanessa L. Allen Sutherland,
Chief Counsel.
[FR Doc. 2011-29155 Filed 11-9-11; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register: September 26, 2006 (Volume 71, Number 186)]
[Notices]
[Page 56145-56146]
[DOCID:fr26se06-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests, and Comments

September 19, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12732-000.
    c. Date filed: August 28, 2006.
    d. Applicant: Natural Currents Energy Services, LLC.
    e. Name of Project: Long Island Sound Tidal Power Project.
    f. Location: The project would be located in Long Island Sound in
Suffolk County, New York.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contacts: Mr. Roger Bason, Natural Currents Energy
Services, LLC, 24 Roxanne Boulevard, Highland, NY 12528, phone: (845)
691-4008.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor 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.
    k. Description of Project: The proposed project would consist of:
(1) Proposed tidal in-stream energy conversion generating units having,
a total installed capacity 2,000 kilowatts, and (2) a proposed
transmission line. The proposed project would have an estimated annual
generation of 1,000

gigawatt-hours and would be sold to a local utility.
    l. Locations of Application: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room, located at 888 First Street NE., Room 2A, Washington DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or e-mail<EMAIL_ADDRESS>For TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item h above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. 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, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments 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 comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', ``COMPETING APPLICATION'' OR
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-15673 Filed 9-25-06; 8:45 am]

BILLING CODE 6717-01-P