[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Rules and Regulations]
[Page 79363-79366]
[DOCID:fr29de08-17]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1026]
RIN 1625-AA00

Safety Zone; Saugus River, Lynn, MA

AGENCY: Coast Guard, DHS.

ACTION: Interim rule with request for comments.

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SUMMARY: The Coast Guard is creating a safety zone for a portion of the
Saugus River in Lynn, Massachusetts as requested by the Massachusetts
Highway Department (MHD), to allow for vital repair work to commence on
the Route 107/Fox Hill Bridge during the winter and spring months. This
zone is necessary to protect mariners from the potential hazards
associated with the

work being conducted by the Commonwealth of Massachusetts in making
critical repairs to the bridge while it is closed to transiting vessels
and vehicular traffic.

DATES: This interim rule is effective December 14, 2008 through May 15,
2009. Comments and related material must reach the Docket Management
Facility on or before January 28, 2009.

ADDRESSES: You may submit comments identified by docket number USCG-
2008-1026 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods. For
instructions on submitting comments, see the ``Public Participation and
Request for Comments'' portion of the SUPPLEMENTARY INFORMATION section
below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this interim
rule, call Chief Eldridge McFadden, Waterways Management at 617-223-
3000. If you have questions on viewing or submitting material to the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2008-1026), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an e-mail address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert ``USCG-2008-1026'' in the Docket ID box, press Enter,
and then click on the balloon shape in the Actions column. If you
submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change this rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert USCG-2008-1026 in the Docket ID box, press Enter, and
then click on the item in the Docket ID column. You may also visit
either the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays; or United States Coast
Guard Sector Boston, 427 Commercial St, Boston, MA 02109 between 7 a.m.
and 3 p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Regulatory Information

    The Coast Guard is issuing this interim rule 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 it is in the best interest of the
public to protect against the potential hazards associated with the
bridge repair work to be conducted on the Route 107/Fox Hill Bridge.
Further, the logistics with respect to that repair work were neither
settled, nor provided, to the Coast Guard with sufficient time to draft
and publish an NPRM, as such it would be impractical to delay the
effective date of this rule as delaying the effective date would limit
our ability to prevent, to the extent practicable, the exposure of
members of the public to the hazards associated with the bridge repair
work.
    For the same reasons, 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.

Background and Purpose

    A meeting between the Coast Guard, local lobstermen, local marina
operators, lobster purchasing agents, and the bridge owner, MHD, was
held on September 10, 2008. The owner of the bridge presented
engineering evidence of the poor condition of the bridge and the need
to perform major bridge repairs during the winter months. It was
concluded that in order to keep the bridge operating safely and
reliably until the major repairs can commence, the number of bridge
openings must be reduced to save wear and tear on the mechanical
components. A temporary deviation from standard bridge operation was
deemed necessary in order to insure that the bridge continues to
operate in a safe reliable manner until the major repairs can be made.
No objection to the proposed temporary deviation schedule was voiced by
interested parties. In rulemaking supporting that decision, the Coast
Guard published a temporary change to

the Saugus Drawbridge Operation regulations (USCG-2008-0969) in the
Federal Register on October 15, 2008 (73 FR 60954) allowing a deviation
of the drawbridge operating guidelines. This regulation, effective from
October 15, 2008 through December 15, 2008, allows the bridge to remain
closed, opening on signal only on the half hour and hour.
    In addition, the long-term repairs may only take place by closing
the bridge to both vehicular and vessel traffic, and removing portions
of the bridge for work. Massachusetts Highway Department must bring in
a large crane barge in order to conduct work on the bridge. This barge
will be crossing the river, effectively restricting the use of the
river. Frequently moving the barge to allow vessel traffic to pass is
contrary to the public interest as it would further delay the bridge
repairs well into the summer months, which are the primary boating and
fishing seasons in Massachusetts. In order the assist the local
lobstermen, MHD proposed to install a temporary dock system on the
downstream of the existing bridge to mitigate the impacts of closing
the bridge and blocking the channel with a large work barge. During the
meeting the lobstermen indicated that the proposed dates for the bridge
closure and waterway restriction along with the installation of a
temporary dock system would be a good compromise that would satisfy
their needs and still allow the rehabilitation bridge repairs to be
completed late May 2009.
    An additional meeting between the Coast Guard, town officials,
harbormaster and MHD took place on December 4, 2008, at which time the
MHD agreed to work with affected waterway users to remove the crane
barge restricting the waterway on no more than six occasions during the
repair process to allow vessels that are able to pass beneath the
bridge while in a closed position to do so.

Discussion of Rule

    This rule is effective from midnight on December 14, 2008 through
midnight on May 15, 2009. The rule establishes a safety zone extending
50 yards upriver from 107/Fox Hill Bridge in the Saugus River in Lynn,
Massachusetts. While this safety zones has the practical effect of
closing that portion of the waters, because (1) Recreational boating
traffic is limited this particular time of year, (2) the MHD has made
alternate mooring and docking arrangements for the fishermen which
typically dock on the up river side of the bridge, and (3) MHD will
remove the crane barge restricting waterway access under the bridge on
at least six occasions allowing vessel traffic which may do so to pass
beneath the closed bridge, the Captain of the Port anticipates minimal
negative impact on vessel traffic. Public notifications will be made
prior to and during the effective period via Local and Broadcast Notice
to Mariners.

Regulatory Analyses

    We developed this interim rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    The Coast Guard expects the economic impact of this rule to be so
minimal that a full Regulatory Evaluation is unnecessary. Although this
rule may prevent traffic from transiting a portion of the Saugus River
during the bridge repairs, the effect of this rule will not be
significant for several reasons: Alternate arrangements for the offload
and mooring of fishing vessels have been made, recreational boaters
typically have their boats out of the water at this time of year in
order to protect them from winter icing, MHD will remove the crane
barge restricting waterway access on at least six occasions as
requested by a waterway users (during which times vessel operators may
request permission to transit through the safety zone promulgated by
this rule), and continued notifications will be made to the local
maritime community by broadcast and local notice to mariners.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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 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.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of fishing and recreational
vessels intending to transit or anchor in a portion of the Saugus River
from midnight December 14, 2008 through midnight on May 15, 2009. This
closure will not have a significant economic impact on a substantial
number of small entities for the reasons described under the Regulatory
Planning and Review section.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    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.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 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.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 5100.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). Based on our analysis
we have determined that the action to establish this safety zone is
included in the category of actions that the Coast Guard has determined
will not result in significant individual or cumulative effects on the
human environment. In addition, we have concluded that there are no
extraordinary circumstances in this case that would limit the use of a
categorical exclusion as described under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental analysis and documentation.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES. The Coast Guard will review this environmental evaluation in
light of any comments received in response to this notice.

List of Subjects in 33 CFR Part 165

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

0
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. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T01-1026 to read as follows:

Sec.  165.T01-1026  Safety Zones; Saugus River, Lynn, Massachusetts.

    (a) Location. The following area is a safety zone: All waters from
surface to bottom of the Saugus River for 50 yards on the upriver side
of the Route 107/Fox Hill Bridge.
    (b) Enforcement Period. This rule will be enforced from midnight on
December 14, 2008 until midnight on May 15, 2009.
    (c) Definitions. Designated representative, as used in this
section, means a Coast Guard Patrol Commander, including a Coast Guard
coxswain, petty officer, or other officer operating a Coast Guard
vessel and a Federal, State, and local officer designated by or
assisting the Captain of the Port (COTP).
    (d) Regulations. (1) In accordance with the general regulations in
165.23 of this part, entry into or movement within this zone by any
person or vessel is prohibited unless authorized by the Captain of the
Port (COTP) Boston or the COTP's designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP via VHF channel 16 or<PHONE_NUMBER> to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zone must comply with all directions given to
them by the COTP.

    Dated: December 10, 2008.
Claudia C. Gelzer,
Commander, U.S. Coast Guard, Acting Captain of the Port Boston.
[FR Doc. E8-30761 Filed 12-24-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: January 30, 2008 (Volume 73, Number 20)]
[Notices]
[Page 5601-5602]
[DOCID:fr30ja08-120]

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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 27d-1 and Form N-27D-1; SEC File No. 270-499; OMB Control
No. 3235-0560.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 350l et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information under the Investment Company Act of 1940
(``Act'') summarized below. The Commission plans to submit these
collections of information to the Office of Management and Budget for
approval.
    Rule 27d-1 (17 CFR 270.27d-1) is entitled ``Reserve Requirements
for Principal Underwriters and Depositors To Carry Out The Obligations
To Refund Charges Required by Section 27(d) and Section 27(f) of the
Act.'' Form N-27D-1 (17 CFR 274.127d-1) is entitled ``Accounting of
Segregated Trust Account.'' Rule 27d-2 (17 CFR 270.27d-2) is entitled
``Insurance Company Undertaking in Lieu of Segregated Trust Account.''
Rule 27d-1 requires the depositor or principal underwriter for an
issuer to deposit funds into a segregated trust account to provide
assurance of its ability to fulfill its refund obligations under
sections 27(d) and 27(f). The rule sets forth minimum reserve amounts
and guidelines for the management and disbursement of the assets in the
account. A single account may be used for the periodic payment plans of
multiple investment companies. Rule 27d-1(j) directs depositors and
principal underwriters to make an accounting of their segregated trust
accounts on Form N-27D-1, which is intended to facilitate the
Commission's oversight of compliance with the reserve requirements set
forth in rule 27d-1. The form requires depositors and principal
underwriters to report deposits to a segregated trust account,
including those made pursuant to paragraphs (c) and (e) of the rule.
Withdrawals pursuant to paragraph (f) of the rule also must be
reported. In addition, the form solicits information regarding the
minimum amount required to be maintained under paragraphs (d) and (e)
of rule 27d-1. Depositors and principal underwriters must file the form
once a year on or before January 31 of the year following the year for
which information is presented.
    Instead of relying on rule 27d-1 and filing Form N-27D-1,
depositors or principal underwriters for the issuers of periodic
payment plans may rely on the exemption afforded by rule 27d-2. In
order to comply with the rule: (i) The depositor or principal
underwriter must secure from an insurance company a written guarantee
of the refund requirements, (ii) the insurance company must satisfy
certain financial criteria, and (iii) the depositor or principal
underwriter must file as an exhibit to the issuer's registration
statement, a copy of the written undertaking, an annual statement that
the insurance company has met the requisite financial criteria on a
monthly basis, and an annual audited balance sheet.
    Rules 27d-1 and 27d-2, which were explicitly authorized by statute,
provide assurance that depositors and principal underwriters of issuers
have access to sufficient cash to meet the demands of certificate
holders who reconsider their decisions to invest in a periodic payment
plan. The information collection requirements in rules 27d-1 and 27d-2
enable the Commission to monitor compliance with reserve rules.

    The depositor or principal underwriter of issuers must file a Form
N-27D-1 annually or comply with the requirements in rule 27d-2. The
Commission received zero Form N-27D-1 filings in 2007. Therefore, the
total annual hour burden associated with rule 27d-1 and Form N-27d-1 is
estimated to be zero hours; however, we are requesting 1 burden hour
for administrative purposes.
    Only one registered investment company has issued a new periodic
payment plan certificate within the past 18 months, and the principal
underwriter or depositor for this sole issuer relies on the exemption
in rule 27d-2. The respondent makes approximately three responses per
year.\1\ The insurance company provides the written undertaking, annual
statement, and certified balance sheet at no cost to the respondent.
The staff estimates that the respondent spends approximately one hour
per year filing the required documents from the insurance company on
EDGAR. Thus, we estimate that the annual burden is approximately 1
hour.
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    \1\ The three responses are: (i) Obtaining and filing the
written undertaking or an amendment to the undertaking, (ii) filing
the insurance company's annual statement that the financial
conditions were satisfied, and (iii) filing the insurance company's
certified balance sheet.
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    The staff believes that rules 27d-1 and 27d-2 and Form N-27D-1 do
not impose any cost burdens other than those arising from the hour
burdens discussed above.
    The estimates of average burden hours and costs are made solely for
the purposes of the Paperwork Reduction Act, and are not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms.\2\
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    \2\ These estimates are based on telephone interviews between
the Commission staff and representatives of depositors or principal
underwriters of periodic payment plan issuers.
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    Complying with the collection of information requirements of rule
27d-1 is mandatory for depositors or principal underwriters of issuers
of periodic payment plans unless they comply with the requirements in
rule 27d-2. The information provided pursuant to rules 27d-1 and 27d-2
is public and, therefore, will not be kept confidential. 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 OMB
control number.
    Written comments are invited on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission'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 R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312; or
send an e-mail to<EMAIL_ADDRESS>
    Dated: January 22, 2008.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-1618 Filed 1-29-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 79 (Thursday, April 24, 2014)]
[Rules and Regulations]
[Pages 22768-22769]
[FR Doc No: 2014-09142]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0025; Airspace Docket No. 14-ANE-1]

Amendment of Class E Airspace; Greenville, ME

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E Airspace at Greenville, ME, as the
Squaw Non-Directional Beacon (NDB) has been decommissioned, requiring
airspace redesign at Greenville Municipal Airport. This enhances the
safety and management of aircraft operations at the airport. This
action also updates the geographic coordinates of the airport.

DATES: Effective 0901 UTC, July 24, 2014. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On February 12, 2014, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E airspace at
Greenville Municipal Airport, Greenville, ME, (79 FR 8362). Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9X dated August 7, 2013, and effective September 15,
2013, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace extending upward from 700 feet above
the surface within a 9.4-mile radius of Greenville Municipal Airport,
with a segment extending from the 9.4-mile radius to 14 miles northwest
of the airport.
    Airspace reconfiguration is necessary due to the decommissioning of
the Squaw NDB and cancellation of the NDB approach, and for continued
safety and management of IFR operations at the airport. The geographic
coordinates of the airport also are adjusted to be in concert with
FAA's aeronautical database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and

unlikely to result in adverse or negative comments. It, therefore, (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); and (3) does not warrant
preparation of a Regulatory Evaluation as the anticipated impact is so
minimal. Since this is a routine matter that only affects air traffic
procedures and air navigation, it is certified that this rule, when
promulgated, does not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Greenville Municipal Airport,
Greenville, ME.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, effective September 15, 2013, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE ME E5 Greenville, ME [Amended]

Greenville Municipal Airport, ME
    (Lat. 45[deg]27'46'' N., long. 69[deg]33'06'' W.)

    That airspace extending upward from 700 feet above the surface
within a 9.4-mile radius of Greenville Municipal Airport, and within
2 miles each side of the 320[deg] bearing of the airport extending
from the 9.4-mile radius to 14 miles northwest of the airport.

    Issued in College Park, Georgia, on April 14, 2014.
Myron A. Jenkins,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2014-09142 Filed 4-23-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 29, 2010 (Volume 75, Number 124)]
[Notices]
[Page 37509-37510]
[DOCID:fr29jn10-112]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62352; File No. SR-NYSEArca-2010-54]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Arca, Inc. Adopting Rule
0 To Provide That Certain References in Exchange Rules Should Be
Understood To Also Include FINRA, as Applicable

June 22, 2010.
    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and rule 19b-4 thereunder,\3\ notice is hereby
given that, on June 14, 2010, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt rule 0 to provide that certain
references in Exchange rules should be understood to also include
FINRA, as applicable. The text of the proposed rule change is available
at the Exchange, the Commission's Web site at http://www.sec.gov, the
Commission's Public Reference Room, and http://www.nyse.com.

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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The purpose of this proposed rule change is to establish rule 0 to
provide that certain references in Exchange rules should be understood
to also include FINRA, as applicable. Specifically, proposed rule 0
sets forth that the Exchange and FINRA are parties to a Regulatory
Services Agreement (``RSA'') pursuant to which FINRA has agreed to
perform certain of the Exchange's member regulatory functions on behalf
of the Exchange \4\ and that Exchange rules that refer to NYSE
Regulation, Inc., NYSE Regulation staff or departments, Exchange staff,
and Exchange departments should be understood as also referring to
FINRA staff and FINRA departments acting on behalf of the Exchange
pursuant to the RSA, as applicable. The proposed new rule further
provides that notwithstanding that the Exchange has entered into an RSA
with FINRA to perform certain of the Exchange's member regulatory
functions, the Exchange shall retain ultimate legal responsibility for,
and control of, such functions.
---------------------------------------------------------------------------

    \4\ The Exchange and FINRA are also party to an allocation plan
pursuant to section 17(d)(1) of the Securities Exchange Act of 1934
and rule 17d-2 thereunder.
---------------------------------------------------------------------------

Background
    NYSE Group, NYSE Regulation, Inc. (``NYSE Regulation''), NYSE Arca,
New York Stock Exchange LLC (``NYSE''), and NYSE Amex LLC (``NYSE
Amex'') (collectively, the ``NYSE Group Exchanges'') anticipate
entering into an RSA and an allocation plan pursuant to section
17(d)(1) of the Securities Exchange Act of 1934 and rule 17d-2
thereunder that together, when effective, will result in consolidating
with FINRA essentially all member regulatory functions that are
currently performed by NYSE Regulation on behalf of the Exchange and
the other NYSE Group Exchanges.\5\ The evolution and increasing
fragmentation of the securities markets has heightened the need for
effective cross-market, cross-product oversight, and the Exchange
believes that as a centralized regulatory utility, FINRA is well
positioned to perform such consolidated regulatory services. Among
other things, FINRA will conduct examinations and surveillance of
member and member firm conduct under Exchange rules, investigate and
enforce violations of Exchange rules, and conduct disciplinary
proceedings arising out of such enforcement actions. NYSE Regulation
currently performs the Exchange's regulatory functions pursuant to a
regulatory services agreement.\6\
---------------------------------------------------------------------------

    \5\ NYSE Regulation will continue to have ultimate authority (as
between itself and FINRA) regarding the proper interpretation of the
rules of the NYSE Group Exchanges. NYSE Regulation will also
continue to be responsible for listing regulation at the NYSE
Exchanges.
    \6\ NYSE Regulation currently performs the regulatory functions
of NYSE Arca and NYSE Amex pursuant to RSAs and of NYSE pursuant to
delegated authority.
---------------------------------------------------------------------------

Proposed Rule
    In connection with the FINRA Consolidation, the Exchange proposes
to establish NYSE Arca rule 0. As proposed, rule 0 sets forth that: (i)
The Exchange and FINRA are parties to an RSA pursuant to which FINRA
has agreed to perform certain of the Exchange's member regulatory
functions on behalf of the Exchange; and (ii) Exchange rules that refer
to NYSE Regulation, Inc., NYSE Regulation staff or departments,
Exchange staff, and Exchange departments should be understood as also
referring to FINRA staff and FINRA departments acting on behalf of the
Exchange pursuant to the RSA, as applicable. Additionally, proposed
rule 0 would set forth that notwithstanding that the Exchange has
entered into an RSA with FINRA to perform certain of the Exchange's
member regulatory functions, the Exchange shall retain ultimate legal
responsibility for, and control of, such functions. As noted above, the
Exchange will be consolidating essentially all member regulatory
functions with FINRA, in order to enhance cross-market, cross-product
regulatory oversight and address the increasing market fragmentation.
In connection therewith, FINRA is hiring substantially all the
management and staff from NYSE Regulation who do market surveillance
and enforcement for the NYSE Group Exchanges, so that the expertise
related to those functions will reside with FINRA. Thus, the Exchange
will necessarily rely on FINRA to determine the manner by which the
regulatory services will be provided and the appropriate regulatory
action to be taken to address particular matters. While the Exchange
will have oversight rights with respect to FINRA's performance under
the RSA, it will not exercise day to day control of such functions.

    The proposed rule text is substantially identical to Nasdaq rule
0130.
2. Statutory Basis
    The Exchange believes that the proposed rule changes [sic] are
consistent with section 6(b) of the Act,\7\ in general, and further the
objectives of section 6(b)(5) of the Act,\8\ in particular, in that
they [sic] are designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest. The Exchange believes that the proposed rule changes
[sic] support the objectives of the Act by providing greater
transparency to members and member organizations that FINRA will be
providing regulatory services on behalf of the Exchange and that
therefore the entity contacting members and member organization in
connection with such regulation may be FINRA, even if an Exchange rule
specifies that NYSE Regulation or the Exchange will be performing such
function.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to section 19(b)(3)(A) of the Act \9\ and rule 19b-
4(f)(6) \10\ thereunder.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Commission believes that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest,
because such waiver will enable the Exchange to implement new rule 0
commensurate with its entering into the RSA. In addition, as noted by
the Exchange, the proposal is consistent with the rules of other self-
regulatory organizations previously approved by the Commission.\11\ For
these reasons, the Commission designates the proposed rule change as
operative upon filing.\12\
---------------------------------------------------------------------------

    \11\ See Nasdaq rule 0130 and BATS rule 8.1(d).
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2010-54 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2010-54. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, on
official business days between the hours of 10 a.m. and 3 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; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2010-54 and should be submitted on or before
July 20, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-15753 Filed 6-28-10; 8:45 am]
BILLING CODE 8010-01-P


Approach for differentiating nanoscale materials based on the size criterion using number of modes by count and size, locations of modes by size, mean size count, and standard deviations centered around mean sized count.
Background
EPA is proposing in its proposed 8(a) and significant new use rules to differentiate discrete nanoscale materials (NMs) based on the numeric middle of a particle size range whose resolution varies according to the width of the range (the current proposal outlines five ranges: 1  -  20 nm; 20  -  50 nm; 50  -  1000 nm; and 1000  -  10000 nm).  For example, the numeric middle of a NM with 90% of the primary particle sizes falling between 55 - 65 nm is 60 nm.  There are several considerations and parameters to consider beyond this specific approach:
   1. No scientific literature has differentiated or identified NMs based on the numeric middle of the size range.
   2. Extensive scientific and mathematical literature has dealt with distributions of various properties and typically identifies four properties to characterize a distribution, as well as the type of distribution itself: mean or average, variance, skewness, and kurtosis.   Common distributions include: normal, Poisson, Rayleigh, exponential, and geometric, but there are many others.
   3. Figures 1-3 illustrate different particle size distributions that, under the proposed approach, would be considered to be the same "nanoscale material" despite scientific studies demonstrating that these substances have different environmental properties (Auffan, Rose et al. 2009):
         a. Figure 1

Figure 1 illustrates a broad distribution and a narrow one that have the same "middle" of the range.  The peaks are also constructed to have the same mean of particles by count, though not by mass.  The black line indicates the mean at 50nm, which is also the middle of each range, while each dashed vertical line represents two standard deviations from the mean (roughly 95% of the particle size distribution) for the respective distributions.

Figure 2 illustrates two materials have different means and skewness (there is >5nm difference between the means), but 95% of the particle s fall into the same size range (represented by the dashed vertical lines) . The distribution for material 1 has relatively small particles and is skewed left, while the distribution for material 2 has relatively large particles and is skewed right.  Even though the majority of the particle sizes are different in each distribution, they would still be considered the same "material" under the current proposal.  The mean by count for each material are represented by the solid vertical lines.

Figure 3 illustrates a material with bimodal distribution (#1) with the same mean and width of range as material #2.  Line a represents the mean for both substances, which also happens to be the median for material #2.  The median for material #1 is at line b.  Lines c & d are the modes for material #1.

Although the proposed approach as described in the current rule could simplify understanding of and compliance with the rule, the differences in environmental parameters based on different size distributions support the idea for a more rigorous approach.  At the same time, more complexity or nuance does not mean a regulated entity would be unable to meet the requirements, because the proposed revised approach is based on statistical distributions science.
Foundations for an alternative approach
Although the mathematics of distributions has been extensively described, a rigorous differentiation of NMs based on particle size distributions utilizing a particular type of distribution or distributions, such as utilizing Student's T-test, is probably not warranted. There are several reasons for this:
   1. There are several different types of "particle" including, but not limited to:
         a. Primary particle
         b. Grain
         c. Aggregate
         d. Agglomerate
No single method or protocol exists for characterizing these properties of a single material that can span orders of magnitude of size or to adjust for different conditions.

   2. Under the Nanoscale Material Stewardship Program and the nanoscale notices received under the New Chemicals Program, the Agency has frequently seen particle size distributions that are bimodal size distributions typically representing aggregation and agglomeration processes.  There are several other processes that might generate a bi- or trimodal distribution including particle formation processes that occur under threshold reaction conditions (this might also lead to graininess).  There may be others.

   3. Different shapes will also lead to issues of defining the boundaries of distributions of critical parameters for non-spheroid nanoscale materials like fibers, trees, etc.

   4. Utilizing statistical tools, such as a Student's t-test, to identify whether a particular size distribution is the same or different than another size distribution is a scientifically objective approach to settling the question as to whether two materials are the same from a size perspective within specified limits of statistical uncertainty.  However, this would require embedding the distribution information into the nomenclature of a discrete material.  This strict approach is well outside the norm of how EPA considers distributions in Unknown Variable Composition and Biological (UVCB) substances for chemical nomenclature.  Second, it would place a large burden on industry to submit and EPA to assess potentially new submissions.
Taking into account the above issues, and given the need to balance simplicity and taking a case-by-case approach, the following framework is an alternative proposal for differentiating NMs from each other based on size.  The other parameters outlined in the proposed rule would remain the same.
Alternative approach

    1. The key parameters of size distributions are:
          a. Number of modes by count and size
          b. Locations of modes by size
          c. Mean size by count
          d. Two standard deviations centered around mean size by count

    2. Each chemical substance that meets the definition of a nanoscale material should be evaluated as to the number of type of critical dimensions.

Scale of dimensions (a, b, and c)
Example Shapes
Number of critical dimensions
Dimensions
Notes
abc

Spheroid, cubes
1
Diameter
Zingg's shape: equant
abc
Irregular shapes, cones
1
Equivalent spherical diameter
Submitter should convert volume or surface area of NM into an equivalent spherical diameter

ab<c
Fiber, needle, rod,
2
Length and diameter
ab should be converted to equivalent circular diameter
Zingg's shape: prolate
ab>c
Ring, sheet, torus
2
Depth and diameter
ab should be converted to equivalent circular diameter
Zingg's shape: oblate
a<b<c
Ribbons, attached or unattached
3
Length, width, depth
Zingg's shape: bladed
       Two dimensions should be considered equivalent or on the "same scale" when each dimension's mean by count are within 3/2 of each other.  This approach was developed by Zingg for use in describing 3-dimensional objects in geology (Zingg 1935)}.  Materials that are "hollow" or that encapsulate another substance should have another critical dimension: internal volume.

    3. Each critical dimension should be defined by the four parameters of the size distribution as follows:

          a. Number of modes by integer number provided the distribution is statistically relevant.  Hence, a bimodal distribution is different than unimodal distribution. A mixture of two normal distributions with equal standard deviations is bimodal only if their means differ by at least twice the common standard deviation (Schilling, Watkins et al. 2002)
          b. Locations of modes by size, mean size by count, two standard deviations centered around mean size by count by the following approaches to size resolution:
                 i. for parameters up to 20 nm, the parameter differs from that of other materials by 2 nm or more,
                 ii. for parameters between 20 and 50 nm, the parameter differs from that of other materials by 5 nm or more,
                 iii. for parameters between 50 and 1000 nm, the parameter differs from that of other materials by 10 nm or more,
                 iv. for parameters between 1000 and 10000 nm, the parameter differs from that of other materials by 100 nm or more,
                 v. for parameters greater than 10000 nm, the parameter differs from that of other materials by 1000 nm or more

    4. Nanoscale materials shall be distinguished by distributions at the primary, secondary, and tertiary structural level, e.g. primary particles, aggregates, and agglomerates.  Hence, an aggregate with a mean size by count of 8 microns would be different than an aggregate with a mean size by count of 4 microns, even if  the nanoscale primary particles of each substance would be considered to have the same size distribution.

Auffan, M., J. Rose, et al. (2009). "Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective." Nat Nano advance online publication.
Schilling, M. F., A. E. Watkins, et al. (2002). "Is Human Height Bimodal?" The American Statistician 56(3): 223-229.
Zingg, T. (1935). "Beitrag zur Schotteranalyse." Schweizerische Mineralogische und Petrographische Mitteilungen 15: 39 - 140.


[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Page 34139]
[FR Doc No: 2018-15393]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0809]

Issuance of Priority Review Voucher; Rare Pediatric Disease
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as amended by the Food and Drug
Administration Safety and Innovation Act (FDASIA), authorizes FDA to
award priority review vouchers to sponsors of approved rare pediatric
disease product applications that meet certain criteria. FDA is
required to publish notice of the award of the priority review voucher.
FDA has determined that EPIDIOLEX (cannabidiol oral solution)
manufactured by GW Research Ltd., meets the criteria for a priority
review voucher.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-
796-9856, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
EPIDIOLEX (cannabidiol oral solution) manufactured by GW Research Ltd.,
meets the criteria for a priority review voucher. EPIDIOLEX
(cannabidiol oral solution) is indicated for the treatment of seizures
associated with Dravet Syndrome or Lennox-Gastaut Syndrome in patients
2 years of age and older.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about EPIDIOLEX (cannabidiol oral solution), go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: July 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15393 Filed 7-18-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Pages 56622-56623]
[FR Doc No: 2020-20104]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-1943]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TAKHZYRO

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for TAKHZYRO and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by November 13, 2020.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by March 15, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 13, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-E-1943 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TAKHZYRO.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management

Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with Sec.
10.20 (21 CFR 10.20) and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product TAKHZYRO
(lanadelumab-flyo). TAKHZYRO is indicated for prophylaxis to prevent
hereditary angioedema in patients 12 years and older. Subsequent to
this approval, the USPTO received a patent term restoration application
for TAKHZYRO (U.S. Patent No. 8,816,055) from Dyax Corp., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated June 21, 2019, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of TAKHZYRO represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TAKHZYRO is 1,857 days. Of this time, 1,616 days occurred during the
testing phase of the regulatory review period, while 241 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 25,
2013. The applicant claims August 2, 2013, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was July 25, 2013,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 26, 2017. FDA has verified the
applicant's claim that the biologics license application (BLA) for
TAKHZYRO (BLA 761090) was initially submitted on December 26, 2017.
    3. The date the application was approved: August 23, 2018. FDA has
verified the applicant's claim that BLA 761090 was approved on August
23, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 849 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: September 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20104 Filed 9-11-20; 8:45 am]
BILLING CODE 4164-01-P


Activity Average Annual Burden Hours ( from Table A 3) Hourly Cost Average Annual Cost Technical Review of revised application & reapplication 3,660 $ 55.20 a $ 202,032 Evaluate revised applications/ reapplications for compliance with 301( h) criteria/ prepare 301( h) decisions 3,675 $ 26.40 b $ 97,011 Evaluate monitoring and toxic control program adequacy 3,000 $ 26.40 b $ 79,200 Review State determinations and State certifications and coordinate with State 240 $ 26.40 b $ 6,336 TOTAL 10,575 $ 384,579 aIt is assumed that the majority of reapplications and additional information submissions are reviewed by a contractor. It is further assumed that the salary level of a contractor working on the 301( h) program is 15 percent higher than that of a GS 9, Step 10, or $ 57,412/ year. Thus, based on 2,080 working hours/ year, the average salary of a contractor is $ 27.60/ hour. Assuming 100 percent overhead costs for the private sector, the labor cost for contractors is $ 55.20.

bIt is assumed that the salary level of the typical government employee working on the 301( h) program is a GS 9, Step 10 salary, or $ 49,924/ year. Based on 2,080 working hours/ year, the average hourly salary of a Federal employee is $ 24.00/ hour. Assuming 10 percent overhead costs, the labor cost for Federal employees is $ 26.40/ hour. TABLE A 1. AVERAGE ANNUAL COST TO THE FEDERAL GOVERNMENT Activity Average Annual Burden Hours Hourly Cost Average Annual Cost Application Revision 2,559 $ 55.20 a $ 141,257 Reapplication 4,218 $ 55.20 a $ 232,834 Monitoring Program 30,960 $ 14.74 b $ 456,350 Toxics Control Program 25,440 $ 14.74 b $ 374,986 TOTAL 63,177 $ 1,205,426 COST TO STATE RESPONDENTS Determination 1,410 20.30 c $ 28,623 Certification 470 20.30 c $ 9,541 TOTAL 1,880 $ 38,164 TOTAL POTW AND STATE RESPONDENTS 65,057 $ 1,243,590 cIt is assumed that the salary level of a typical State government employee working on the 301( h) program is a GS 9, Step 1, or $ 38,406/ year. Based on 2,080 working hours/ year, the average hourly salary of a State government employee is $ 18.46/ hour. Assuming 10 percent overhead costs, the labor cost for State government employees is $ 20.30/ hour. TABLE A 2. COST TO POTW AND STATE aIt is assumed that much of the reapplication and additional information is prepared by a contractor with specialized expertise and equipment. It is further assumed that the salary level of a contractor working on the 301( h) program is 15 percent higher than that of a GS 9, Step 10, or $ 57,412/ year. Thus, based on 2,080 working hours/ year, the average hourly salary of a contractor is $ 27.60/ hour. Assuming 100 percent overhead costs for the private sector, the labor cost for contractors is $ 55.20/ hour.

bIt is assumed that the salary level of a typical local government employee working on the 301( h) program is a GS 5, Step 4, or $ 27,882. Based on 2,080 working hours/ year, the average hourly salary of a local employee is $ 13.40/ hour. Assuming 10 percent overhead costs, the labor cost for local government employees is $ 14.74/ hour. COST TO POTW RESPONDENTS TABLE A 3. FEDERAL GOVERNMENT BURDEN Number of Permits to be Processed Annuallya FY 2003 FY 2004 FY 2005 Activity S L S L S L S L S L TOTAL Technical review of revised application and reapplication 360 1650 1 2 1 2 1 2 1,080 9,900 10,980 3,660 Evaluate revised applications and reapplications for compliance with 301( h)

criteria 208 1040 6 3 6 2 6 2 3,744 7,280 11,024 3,675 Evaluate monitoring and toxic control program adequacy 60 100 30 12 30 12 30 12 5,400 3,600 9,000 3,000 Review State determinations and State certifications and coordinate with the State 20 20 7 5 7 5 7 5 420 300 720 240 TOTAL 10,644 21,080 31,724 10,575 NOTE: S = small, L = large aIncorporates EPA's estimate of how many permittees are expected to revise applications and apply for reissuance. These numbers are consistent with those used on Tables A 6, A 7, A 8, and A 10.

bCalculated by dividing total by 3. Average Annual Burdenb Federal Burden Hours/ Activity for 3 Years of ICR Burden Hours/ Activity TABLE A 4. ANNUAL, TOTAL AND AVERAGE BURDENS FOR EACH OF THE SEVEN INFORMATION ACTIVITIES FY 2004 FY 2004 FY 2005 TOTAL Average Activity/ Unit Burden Burden Hours Number Affected Burden All Number Affected Burden All Number Affected Burden All Number Affected Burden All Number Affected Burden All Application Revision ( POTW)

Sm Facility Hr. 255 1 255 1 255 1 255 3 765 1 255 Lg. Facility Hr. 1,152 2 2,304 2 2,304 2 2,304 6 6,912 2 2,304 SUBTOTAL 3 2,559 3 2,559 3 2,559 9 7,677 3 2,559 Reapplication ( POTW)

Sm Facility Hr. 255 6 1,530 6 1,530 6 1,530 18 4,590 6 1,530 Lg. Facility Hr. 1,152 3 3,456 2 2,304 2 2,304 7 8,064 2 2,688 SUBTOTAL 9 4,986 8 3,834 8 3,834 25 12,654 8 4,218 Monitoring ( POTW)

Sm Facility Hr. 328 30 9,840 30 9,840 30 9,840 90 29,520 30 9,840 Lg. Facility Hr. 1,760 12 21,120 12 21,120 12 21,120 36 63,360 12 21,120 SUBTOTAL 42 30,960 42 30,960 42 30,960 126 92,880 42 30,960 Toxics Control Sm Facility Hr. 80 30 2,400 30 2,400 30 2,400 90 7,200 30 2,400 Lg. Facility Hr. 1,920 12 23,040 12 23,040 12 23,040 36 69,120 12 23,040 SUBTOTAL 42 25,440 42 25,440 42 25,440 126 76,320 42 25,440 TOTAL ( POTWs)

Sm Facility Hr. 30 14,025 30 14,025 30 14,025 90 42,075 30 14,025 Lg Facility Hr. 12 49,920 12 48,768 12 48,768 36 147,456 12 49,152 TOTAL ( All POTWs) a 42 63,945 42 62,793 42 62,793 126 189,531 42 63,177 Determination ( States)

Sm Facility Hr. 90 7 630 7 630 7 630 21 1,890 7 630 Lg Facility Hr. 180 5 900 4 720 4 720 13 2,340 4 780 SUBTOTAL 12 1,530 11 1,350 11 1,350 34 4,230 11 1,410 Certification ( States)

Sm Facility Hr. 30 7 210 7 210 7 210 21 630 7 210 Lg Facility Hr. 60 5 300 4 240 4 240 13 780 4 260 SUBTOTAL 12 510 11 450 11 450 34 1,410 11 470 Total ( States) b 9 2,040 9 1,800 9 1,800 9 5,640 9 1,880 GRAND TOTAL( States +

POTWs) 51 65,985 51 64,593 51 64,593 51 195,171 51 65,057 aThere are 42 POTWs in the 301( h) universe.

bThere are 9 States in the 301( h) universe. Activities Small Large Read Instructions 8 16 Plan Activities 8 16 Create Information 80 320 Gather Information 135 320 Complete Information 24 480 TOTAL 255 1,152 Burden Hours TABLE A 5. APPLICATION REVISION AND REAPPLICATION ACTIVITIES AND BURDEN HOURS FOR POTWS FY 2003 FY 2004 FY 2005 TOTAL Average Annuala S L S L S L S L Number of Respondents 1 2 1 2 1 2 3 6 3 Burden ( burden from Table A 5 x number of respondents) 255 2,304 255 2,304 255 2,304 765 6,912 2,559 Note: S = small, L = large aCalculated by dividing the total small and large POTWs for 3 years by 3.

TABLE A 6. ANNUAL POTW RESPONDENTS AND TOTAL ANNUAL BURDEN OF APPLICATION REVISION FY 2003 FY 2004 FY 2005 TOTAL Average Annuala S L S L S L S L Number of Respondents 6 3 6 2 6 2 18 7 8 Burden ( burden from Table A 5 x number of respondents) 1,530 3,456 1,530 2,304 1,530 2,304 4,590 8,064 4,218 Note: S = small, L = large aCalculated by dividing the total small plus large POTWs for 3 years by 3. TABLE A 7. ANNUAL POTW RESPONDENTS AND TOTAL ANNUAL BURDEN OF REAPPLICATION Burden Hours/ Permittee S L S L S L S L FY 2003 FY 2004 FY 2005 TOTAL Monitoring Program 30 12 30 12 30 12 42 328 1,760 30,960 30,960 30,960 92,880 30,960 Toxics Control Program 30 12 30 12 30 12 42 80 1,920 25,440 25,440 25,440 76,320 25,440 Note: S = small, L = large aCalculated by dividing the total annual burden of small plus large POTWs for 3 years by 3.

FY 2003 FY 2004 FY 2005 Average Annual Number of Respondents Average Annual Burdena Number of Respondents Annual Burden TABLE A 8. ANNUAL POTW RESPONDENTS AND TOTAL ANNUAL BURDEN OF MONITORING AND TOXICS CONTROL PROGRAM State Determination 401 Certification Activity Smalla Largea Small Large Identify Applicable Requirements 8 8 4 4 Analyze Material 69 155 17 43 Review Accuracy 8 10 4 6 Report Information 5 7 5 7 TOTAL 90 180 30 60 aBurden for application revisions and reapplications. TABLE A 9. BURDEN FOR STATE DETERMINATIONS AND 401( A)( 1) CERTIFICATIONS Burden ( Hours/ Activity) FY 2003a FY 2004 FY 2005 S L S L S L Number of Respondents 7 5 7 4 7 4 34 11 Burdenb 630 900 630 720 630 720 4,230 1,410 Note: S = small, L = large TABLE A 10. ANNUAL RESPONDENTS AND TOTAL ANNUAL BURDEN OF STATE DETERMINATIONS aCalculated by dividing the number of respondents and the total burden for 3 years by 3. There are 9 states in the 301( h)

universe. bCalculated by multiplying burden estimates in Table A 9 by the corresponding number of respondents in each information submission category. Total Average Annuala FY 2003 FY 2004 FY 2005 S L S L S L Number of Respondentsb 7 5 7 4 7 4 34 11 Burdenc 210 300 210 240 210 240 1410 470 Note: S = small, L = large cCalculated by multiplying burden estimates in Table A 9 by number of respondents. TABLE A 11. ANNUAL RESPONDENTS AND TOTAL ANNUAL BURDEN OF STATE 401( a)( 1) CERTIFICATION bNumber derived by assuming 34 permit reapplications and application revisions over 3 years of the ICR; 21 small and 13 large; and will result in the final approval and preparation of a draft permit, thus requiring State certification. It is assumed that the application review process takes approximately one year. Total Average Annuala aCalculated by dividing total burden hours and number of respondents for the 3 years by 3. There are 9 states in the 301( h) universe. Respondent/ Activity Number of Respondents Hours per Responseb Average Annual Burden POTWs Application Revision 3 853 2,559 Reapplication 9 469 4,218 Monitoring Program 42 737 30,960 Toxics Control Program 42 606 25,440 TOTAL 42 63,177 STATES Determinations 11 128 1,410 Certifications 11 43 470 TOTAL 9 1,880 TOTAL: POTW AND STATE 65,057 aAverage of 3 years divided by 3.

b Hours per response were calculated by dividing the average annual burden by the number of respondents. Values have been rounded to the nearest hour. TABLE A 12. SUMMARY TABLEa Activity Burden from Previous ICR Burden from This ICR Difference Reason for Change Application Revision 2,559 2,559 0 Reapplication 4,687 4,218  469 Fewer respondentsb Additional Information 680 NA  680 Additional information no longer applicable. Monitoring Program 33,376 30,960  2,416 Fewer respondentsb Toxics Control Program 27,520 25,440  2,080 Fewer respondentsb State Determination ( Includes reviewing additional information) 1,727 1,410  317 Fewer respondents and information requirements. a, b State Certification 500 470  30 Fewer respondentsb TOTAL 71,049 65,057  5,992 Fewer respondents and information requirementsa, b b301( h) universe has decreased since the previous ICR TABLE A 13. EXPLANATION OF CHANGE IN BURDEN aChange in program status


region facility species. orig stage year impinged. est entrained. est notes dummy dummy dummy dummy  999  999  999 dummy reservoir comanche aplodinotus egg 1993 . 10,584,833 RM# 35657; Table 7 9 reservoir comanche aplodinotus larvae 1993 . 4,971,407 RM# 35657; Table 7 9 reservoir comanche dorosoma larvae 1993 . 8,969,228 RM# 35657; Table 7 9 reservoir comanche dorosoma juv 1993 . 574,520 RM# 35657; Table 7 9 reservoir comanche menidia egg 1993 . 1,444,317 RM# 35657; Table 7 9 reservoir comanche menidia larvae 1993 . 696,003 RM# 35657; Table 7 9 reservoir comanche centrarchidae larvae 1993 . 4,437,167 RM# 35657; Table 7 9 reservoir comanche lepomis larvae 1993 . 10,160,031 RM# 35657; Table 7 9 reservoir comanche lepomis juv 1993 . 439,446 RM# 35657; Table 7 9 reservoir comanche morone larvae 1993 . 5,365,227 RM# 35657; Table 7 9 reservoir comanche threadfin. shad age01 1993 251,269 . RM# 35657; Table 7 10 reservoir comanche bluegill. sunfish age01 1993 4,626 . RM# 35657; Table 7 10 reservoir comanche inland. silverside age01 1993 3,100 . RM# 35657; Table 7 10 reservoir comanche green. sunfish age01 1993 1,144 . RM# 35657; Table 7 10 reservoir comanche largemouth. bass age01 1993 908 . RM# 35657; Table 7 10 reservoir comanche gizzard. shad age01 1993 829 . RM# 35657; Table 7 10 reservoir comanche channel. catfish age01 1993 177 . RM# 35657; Table 7 10 reservoir comanche warmouth. sunfish age01 1993 142 . RM# 35657; Table 7 10 reservoir comanche freshwater. drum age01 1993 85 . RM# 35657; Table 7 10 reservoir comanche redear. sunfish age01 1993 78 . RM# 35657; Table 7 10 reservoir comanche white. bass age01 1993 70 . RM# 35657; Table 7 10 reservoir comanche white. crappie age01 1993 42 . RM# 35657; Table 7 10 reservoir comanche longear. sunfish age01 1993 28 . RM# 35657; Table 7 10 qc dummy lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer lefer species stage year unit1. entrained. est unit2. entrained. est entrained. est impinged. est aplodinotus eggs 1993 4908211 5676622 10584833 . aplodinotus larvae 1993 3487743 1483664 4971407 . aplodinotus juv 1993 0 0 0 . dorosoma eggs 1993 0 0 0 . dorosoma larvae 1993 5790969 3178259 8969228 . dorosoma juv 1993 287835 286685 574520 . menidia eggs 1993 721945 722372 1444317 . menidia larvae 1993 543242 152761 696003 . menidia juv 1993 0 0 0 . centrarchidae eggs 1993 0 0 0 . centrarchidae larvae 1993 3137659 1299508 4437167 . centrarchidae juv 1993 0 0 0 . lepomis eggs 1993 0 0 0 . lepomis larvae 1993 6665372 3494659 10160031 . lepomis juv 1993 439446 0 439446 . morone eggs 1993 0 0 0 . morone larvae 1993 4378353 986874 5365227 . morone juv 1993 0 0 0 . threadfin. shad age01 1993 . . . 251269 bluegill. sunfish age01 1993 . . . 4626 inland. silverside age01 1993 . . . 3100 green. sunfish age01 1993 . . . 1144 largemouth. bass age01 1993 . . . 908 gizzard. shad age01 1993 . . . 829 channel. catfish age01 1993 . . . 177 warmouth. sunfish age01 1993 . . . 142 freshwater. drum age01 1993 . . . 85 redear. sunfish age01 1993 . . . 78 white. bass age01 1993 . . . 70 white. crappie age01 1993 . . . 42 longear. sunfish age01 1993 . . . 28 notes qc lumping species lumping notes RM# 35657, Table 7 9 lefer freshwater. drum Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer freshwater. drum Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer freshwater. drum Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer gizzard. shad Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer gizzard. shad Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer gizzard. shad Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer non. ris. forage Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer non. ris. forage Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer non. ris. forage Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer white. bass Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer white. bass Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 9 lefer white. bass Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer gizzard. shad Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer bluegill Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer non. ris. forage Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer smallmouth. bass Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer gizzard. shad Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer channel. catfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer freshwater. drum Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer sunfish Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer white. bass Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer crappie Lumping species based on existing life history data and pg. 6 10 RM# 35657, Table 7 10 lefer sunfish Lumping species based on existing life history data and pg. 6 10 Losses data for Comanche Peak Steam Electric Station ( Texas). Cooling water source: Squaw Creek Reservoir. Intake 316( b) Phase III A. Gage, 11/ 19/ 2003 Notes: QC performed by ensuring sums of numbers entered matched the sums presented in RM # 35657 No impingement survival values were presented in the document; assumed 0% survival of impingement.

QC Checked data entry against source documents. Checked that totals on losses page equal data entry. M. Lefer 12/ 9/ 03.


[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Page 11533]
[FR Doc No: 2012-4477]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9637-6]

Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2010;
Notice of Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability and request for comments.

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

SUMMARY: The Draft Inventory of U.S. Greenhouse Gas Emissions and
Sinks: 1990-2010 is available for public review. Annual U.S. emissions
for the period of time from 1990 through 2010 are summarized and
presented by source category and sector. The inventory contains
estimates of carbon dioxide (CO2), methane (CH4),
nitrous oxide (N2O), hydrofluorocarbons (HFC),
perfluorocarbons (PFC), and sulfur hexafluoride (SF6)
emissions. The inventory also includes estimates of carbon fluxes in
U.S. agricultural and forest lands. The technical approach used in this
report to estimate emissions and sinks for greenhouse gases is
consistent with the methodologies recommended by the Intergovernmental
Panel on Climate Change (IPCC), and reported in a format consistent
with the United Nations Framework Convention on Climate Change (UNFCCC)
reporting guidelines. The Inventory of U.S. Greenhouse Gas Emissions
and Sinks: 1990-2010 is the latest in a series of annual U.S.
submissions to the Secretariat of the UNFCCC.

DATES: To ensure your comments are considered for the final version of
the document, please submit your comments on or before March 28, 2012.
However, comments received after that date will still be welcomed and
be considered for the next edition of this report.

ADDRESSES: Comments should be submitted to Mr. Leif Hockstad at:
Environmental Protection Agency, Climate Change Division (6207J), 1200
Pennsylvania Ave. NW., Washington, DC 20460, Fax:<PHONE_NUMBER>. You
are welcome and encouraged to send an email with your comments to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Mr. Leif Hockstad, Environmental
Protection Agency, Office of Air and Radiation, Office of Atmospheric
Programs, Climate Change Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The draft report can be obtained by visiting
the U.S. EPA's Climate Change Site at: http://www.epa.gov/climatechange/emissions/usinventoryreport.html.

    Dated: February 16, 2012.
Gina McCarthy,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 2012-4477 Filed 2-24-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Pages 51963-51964]
[FR Doc No: 2011-21157]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR11-122-000]

Cobra Pipeline Ltd.; Notice of Baseline Filings

    Take notice that on August 12, 2011, Cobra Pipeline Ltd. submitted
a revised baseline filing of their Statement of Operating Conditions
for services provided under Section 311 of the Natural Gas Policy Act
of 1978 (NGPA).
    Any person desiring to participate in this rate proceeding must
file a motion 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 and 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. Such notices, motions, or protests must be filed on or
before the date as indicated below. Anyone filing an intervention or
protest must serve a copy of that document on the Applicant. Anyone
filing an intervention or protest on or before the intervention or
protest date need not serve motions to intervene or protests on persons
other than the Applicant.
    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 7 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 Wednesday, August 24, 2011.

    Dated: August 12, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-21157 Filed 8-18-11; 8:45 am]
BILLING CODE 6717-01-P