[Federal Register: November 16, 2006 (Volume 71, Number 221)]
[Rules and Regulations]
[Page 66686-66688]
[DOCID:fr16no06-16]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 239 and 258

[EPA-R07-RCRA-2006-0878; FRL-8242-6]

Adequacy of Nebraska Municipal Solid Waste Landfill Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: This action approves Nebraska's Research, Development and
Demonstration (RD&D) permit program and updates to the approved
Municipal Solid Waste Landfill Permit (MSWLP) program. On March 22,
2004, the EPA issued final regulations allowing RD&D permits to be
issued to certain municipal solid waste landfills by approved states.
On September 27, 2006, Nebraska submitted an application to the EPA
seeking Federal approval of its RD&D requirements and to update Federal
approval of its MSWLP program.

DATES: This direct final rule is effective January 16, 2007, without
further notice unless EPA receives adverse comments by January 16,
2007. If adverse comments are received, EPA will publish a timely
response or withdrawal of the direct final rule in the Federal Register
informing the public that the rule will or will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
RCRA-2006-0878, by one of the following methods:
    1. http://www.regulations.gov. Follow the on-line instruction for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>

    3. Mail: Send written comments to Chilton McLaughlin, EPA Region 7,
Solid Waste/Pollution Prevention Branch, 901 North 5th Street, Kansas
City, Kansas 66101.
    4. Hand Delivery or Courier. Deliver your comments to Chilton
McLaughlin, EPA Region 7, Solid Waste/Pollution Prevention Branch, 901
North 5th Street, Kansas City, Kansas 66101.
     Instructions: Direct your comments to Docket ID No. EPA-R07-RCRA-
2006-0878. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://www.regulations.gov
 or e-mail information that you consider to be CBI

or otherwise protected. The http://www.regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
     Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov
 or in hard copy at the Environmental Protection

Agency, Solid Waste/Pollution Prevention Branch, 901 North 5th Street,
Kansas City, Kansas 66101. The Regional Office's official hours of
business are Monday through Friday, 8 to 4:30, excluding Federal
holidays. The interested persons wanting to examine these documents
should make an appointment with the office at least 24 hours in
advance.

FOR FURTHER INFORMATION CONTACT: Chilton McLaughlin at<PHONE_NUMBER>,
or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 22, 2004, the EPA issued final regulations allowing RD&D
permits to be issued at certain municipal solid waste landfills (69 FR
13242). This new provision may only be implemented by an approved
state. While states are not required to seek approval for this new
provision, those states that are interested in providing RD&D permits
to municipal solid waste landfills must seek approval from EPA before
issuing such permits. The current request is for approval to issue RD&D
permits. Nebraska received partial approval for 40 CFR part 258
provisions on October 5, 1993 (58 FR 51819).
    The provision that it received partial approval for derived from an
opinion by the United States Court of Appeals on February 12, 1992,
which instructed EPA to require groundwater monitoring at all
landfills. The updated state rules impose groundwater monitoring at
small, arid landfills. The current request also incorporates the August
7, 1995, rule (60 FR 40105), which corrects the financial assurance
criteria; the September 25, 1996, rule (61 FR 50413), which relates to
groundwater exemptions of small, arid, remote landfills; the November
27, 1996, rule (61 FR 60328, at 60337), which adds financial mechanisms
for local governments; and the April 10, 1998, rule (63 FR 17706, at
17729), which adds a financial test and corporate guarantee to
financial assurance mechanisms. Approval procedures for new provisions
of 40 CFR part 258 are outlined in 40 CFR 239.12. On September 27,
2006, Nebraska submitted an amended application for approval of its
RD&D permit provisions and an update of the approved MSWLP program.

II. Decision

    After a thorough review, EPA Region 7 determined that Nebraska's
RD&D provisions and the updated rules for its Municipal Solid Waste
Landfill Permit Program as defined under Nebraska Title 132--Integrated
Solid Waste Management Regulations, effective March 7, 2006, are
adequate to ensure compliance with the Federal criteria as defined at
40 CFR 258.4.

III. Statutory and Executive Order Reviews

    This action approves state solid waste requirements pursuant to
Resource Conservation and Recovery Act (RCRA) Section 4005 and imposes
no Federal requirements. Therefore, this rule complies with applicable
executive orders and statutory provisions as follows:
    1. Executive Order 12866: Regulatory Planning Review--The Office of
Management and Budget has exempted this action from its review under
Executive Order (EO) 12866;
    2. Paperwork Reduction Act--This action does not impose an
information collection burden under the Paperwork Reduction Act;
    3. Regulatory Flexibility Act--After considering the economic
impacts of today's action on small entities under the Regulatory
Flexibility Act, I certify that this action will not have a significant
economic impact on a substantial number of small entities;
    4. Unfunded Mandates Reform Act--Because this action approves pre-
existing requirements under State law and does not impose any
additional enforceable duty beyond that required by State law, this
action does not contain any unfunded mandate, or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Act;
    5. Executive Order 13132: Federalism--EO 13132 does not apply to
this action because this action will not have federalism implications
(i.e., there are no substantial direct effects on States, on the
relationship between the national government and States, or on the
distribution of power and responsibilities between Federal and State
governments);
    6. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments--EO 13175 does not apply to this action because it
will not have tribal implications (i.e., there are no substantial
direct effects 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);
    7. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks--This action is not subject to EO 13045
because it is not economically significant and is not based on health
or safety risks;

    8. Executive Order 13211: Actions that Significantly Affect Energy
Supply, Distribution, or Use--This action is not subject to EO 13211
because it is not a significant regulatory action as defined in EO
12866;
    9. National Technology Transfer Advancement Act--EPA approves State
programs so long as the State programs meet the criteria delineated in
RCRA. It would be inconsistent with applicable law for EPA, in its
review of a State program, to require the use of any particular
voluntary consensus standard in place of another standard that meets
RCRA requirements. Thus, section 12(d) of the National Technology
Transfer and Advancement Act does not apply to this action;
    10. Congressional Review Act--EPA will submit a report containing
this action and other information required by the Congressional Review
Act (5 U.S.C. 801 et seq.) to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication in the Federal Register.

List of Subjects

40 CFR Part 239

    Environmental protection, Administrative practice and procedure,
Intergovernmental relations, Waste treatment and disposal.

40 CFR Part 258

    Reporting and recordkeeping requirements, Waste treatment disposal,
Water pollution control.

    Authority: This action is issued under the authority of section
2002, 4005 and 4010(c) of the Solid Waste Disposal Act, as amended,
42 U.S.C. 6912, 6945 and 6949(a).

    Dated: November 6, 2006.
John B. Askew,
Regional Administrator, Region 7.
 [FR Doc. E6-19388 Filed 11-15-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: June 15, 2010 (Volume 75, Number 114)]
[Notices]
[Page 33803-33804]
[DOCID:fr15jn10-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP10-447-000]

Sabine Pipe Line LLC; Notice of Request Under Blanket
Authorization

June 8, 2010.
    Take notice that on June 1, 2010, Sabine Pipe Line LLC (Sabine),
4800 Fournace Place, Bellaire, Texas 77401, filed in Docket No. CP10-
447-000, a prior notice request pursuant to sections 157.205 and
157.216 of the Federal Energy Regulatory Commission's regulations under
the Natural Gas Act for authorization to abandon, in place, certain
compression facilities, located near Lake Charles, in Calcasieu Parish,
Louisiana, all as more fully set forth in the application, which is on
file with the Commission and open to public inspection. The filing may
also be viewed on the Web at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
TTY,<PHONE_NUMBER>.
    Specifically, Sabine proposes to abandon, in place, the Lake
Charles Compressor Facilities, which include two natural gas-driven
compressor units totaling 2,464 horsepower. Sabine states that for the
past several years, the Lake Charles Compressor Facilities have not
been necessary to provide transportation services on Sabine's
interstate pipeline system, and have been idle and have not operated
since 2000. Sabine avers that current customers will not be affected by
the proposed abandonment.
    Any questions regarding the application should be directed to
Jeffrey L. Kirk, Regulatory Specialist, Chevron Pipe Line Company, 4800
Fournace Place, Bellaire, Texas 77401 at<PHONE_NUMBER>.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu

of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site (http://www.ferc.gov) under the ``e-Filing''
link.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-14301 Filed 6-14-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Rules and Regulations]
[Pages 21681-21683]
[FR Doc No: 2017-09440]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2017-0215; Special Conditions No. 25-669-SC]

Special Conditions: Textron Aviation Inc. Model 700 Airplane;
Design Roll Maneuver Condition

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Textron Aviation
Inc. (Textron) Model 700 airplane. This airplane will have a novel or
unusual design feature when compared to the state of technology
envisioned in the airworthiness standards for transport-category
airplanes. This design feature is an electronic flight-control system
that provides control through pilot inputs to the flight computer. The
applicable airworthiness regulations do not contain adequate or
appropriate safety standards for this design feature. These special
conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: This action is effective on Textron on May 10, 2017. We must
receive your comments by June 26, 2017.

ADDRESSES: Send comments identified by docket number FAA-2017-0215
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search

function of the docket Web site, anyone can find and read the
electronic form of all comments received into any FAA docket, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). DOT's complete
Privacy Act Statement can be found in the Federal Register published on
April 11, 2000 (65 FR 19477-19478)
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Greg Schneider, FAA, Airframe and
Cabin Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA has determined that notice of, and
opportunity for prior public comment on, these special conditions is
impracticable because these procedures would significantly delay
issuance of the design approval and thus delivery of the affected
airplane.
    In addition, the substance of these special conditions has been
subject to the public-comment process in several prior instances with
no substantive comments received. The FAA therefore finds it
unnecessary to delay the effective date and finds tthat good cause
exists for making these special conditions effective upon publication
in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On November 20, 2014, Textron applied for a type certificate for
their new Model 700 airplane. The Model 700 airplane is low-wing,
pressurized, turbofan-powered executive jet airplane with seating for
two crewmembers and up to 12 passengers. This airplane will have two
Honeywell AS907-2-1S turbofan engines and a maximum takeoff weight of
38,514 pounds.

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.17, Textron must show that the Model 700 airplane meets the
applicable provisions of part 25, as amended by Amendments 25-1 through
25-139, 25-141, and 25-143.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Textron Model 700 airplane because
of a novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Model 700 airplane must comply with the fuel-vent and
exhaust-emission requirements of 14 CFR part 34, and the noise-
certification requirements of 14 CFR part 36. The FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Model 700 airplane will incorporate the following novel or
unusual design feature: An electronic flight-control system that
provides control through pilot inputs to the flight computer.

Discussion

    The roll control system uses both ailerons and flight spoilers. The
aileron control system is a fully mechanical system, and the flight
spoilers are fly-by-wire. Section 25.349 specifies roll maneuver load
conditions that are based on aileron deflection, rather than control-
wheel deflection. By specifying the load conditions in terms of aileron
deflection, the current requirement does not address electronic flight
controls that cause nonlinearities and other loads caused by spoilers.
Since this type of system affects flight loads, and therefore the
structural capability of the airplane, special conditions are necessary
to address these effects.
    These special conditions differ from current requirements in that
they require the actuation of the cockpit roll control, as opposed to
the aileron itself, to perform the roll maneuver. Also, these special
conditions require an additional load condition at VA, in
which the cockpit roll control is returned to neutral following the
initial roll input.
    These special conditions differ from similar special conditions
applied to previous similar technologies. These special conditions are
limited to the roll axis only, whereas previous special conditions also
included the pitch and yaw axes. Special conditions are no longer
necessary for the pitch or yaw axes because Amendment 25-91 takes into
account the effects of an electronic flight-control system in those
axes (Sec.  25.331 for pitch and Sec.  25.351 for yaw).
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Textron Model 700 airplane. Should Textron apply at a later date for a
change to the type certificate to include another model incorporating
the same novel or unusual design feature, these special conditions
would apply to that model as well.

Conclusion

    This action affects only one novel or unusual design feature on one
model of airplane. It is not a rule of general applicability.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, because a delay would
significantly affect the certification of the airplane, the FAA has
determined that prior public notice and comment are unnecessary and
impracticable, and good cause exists for adopting these special
conditions upon publication in the Federal Register. The FAA is
requesting comments to allow interested persons to submit views that

may not have been submitted in response to the prior opportunities for
comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Textron Aviation Inc. Model 700
airplanes.
    In lieu of compliance with Sec.  25.349(a), the following
conditions, speeds, and cockpit roll control motions (except as the
motions may be limited by pilot effort) must be considered in
combination with an airplane load factor of zero and of two-thirds of
the positive maneuvering factor used in design. In determining the
resulting control-surface deflections, the torsional flexibility of the
wing must be considered in accordance with Sec.  25.301(b):
    1. Conditions corresponding to steady rolling velocities must be
investigated. In addition, conditions corresponding to maximum angular
acceleration must be investigated for airplanes with engines or other
weight concentrations outboard of the fuselage. For the angular-
acceleration conditions, zero rolling velocity may be assumed in the
absence of a rational time history investigation of the maneuver.
    2. At VA, sudden movement of the cockpit roll control up
to the limit is applied. The position of the cockpit roll control must
be maintained until a steady roll rate is achieved, and then must be
returned suddenly to the neutral position.
    3. At VC, the cockpit roll control must be moved
suddenly and maintained so as to achieve a roll rate not less than that
obtained in paragraph 2.
    4. At VD, the cockpit roll control must be moved
suddenly and maintained so as to achieve a roll rate not less than one
third of that obtained in paragraph 2.

    Issued in Renton, Washington, on April 24, 2017.
Michael Kaszycki,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
[FR Doc. 2017-09440 Filed 5-9-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46496-46497]
[FR Doc No: 2017-21421]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2479]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for KOVALTRY 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 4, 2017. 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 April 3,
2018. 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 December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 4, 2017. 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-2016-E-2479 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; KOVALTRY.'' 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.
     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.gpo.gov/fdsys/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.

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 KOVALTRY
(antihemophilic factor (recombinant)). KOVALTRY is indicated for use in
adults and children with hemophilia A for: (1) On-demand treatment and
control of bleeding episodes; (2) perioperative management of bleeding;
and (3) routine prophylaxis to reduce the frequency of bleeding
episodes. Subsequent to this approval, the USPTO received a patent term
restoration application for KOVALTRY (U.S. Patent No. 5,804,420) from
Bayer HealthCare LLC, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated October 14, 2016, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of KOVALTRY 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
KOVALTRY is 2,478 days. Of this time, 2,021 days occurred during the
testing phase of the regulatory review period, while 457 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: June 5,
2009. FDA has verified the Bayer HealthCare LLC's claim that the date
the investigational new drug application became effective was on June
5, 2009.
    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 16, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
KOVALTRY (BLA 125574/0) was initially submitted on December 16, 2014.
    3. The date the application was approved: March 16, 2016. FDA has
verified the applicant's claim that BLA 125574/0 was approved on March
16, 2016.
    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 1,466 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 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21421 Filed 10-4-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Notices]
[Pages 44715-44716]
[FR Doc No: 2021-17326]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8844-01-R5]

Great Lakes Advisory Board Notice for Virtual Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting for Great Lakes Advisory Board.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), the
Environmental Protection Agency (EPA) provides notice of a public
meeting for the Great Lakes Advisory Board (GLAB). Pre-registration is
required.

DATES: This virtual public meeting will be held on August 30th, 2021
from 1:00 p.m. to 4:00 p.m. Central Daylight Time and August 31st from
9:00 a.m. to 12:00 p.m. Central Daylight Time. Members of the public
seeking to view the meeting must register by 3:00 p.m. Central Daylight
Time on August 23rd, 2021. Members of the public seeking to make
comments relevant to issues discussed at the virtual meeting must
register and indicate a request to make oral and/or written public
comments in advance of

the meeting. For information on how to register, please see [How do I
participate in the meeting] below.

FOR FURTHER INFORMATION CONTACT: Edlynzia Barnes, Designated Federal
Officer (DFO), at<EMAIL_ADDRESS>or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. General Information

    The GLAB is chartered in accordance with the Federal Advisory
Committee Act (FACA) of 1972 (5 U.S.C., Appendix 2, as amended) and 41
CFR 102-3.50(d). The Advisory Board provides advice and recommendations
on matters related to the Great Lakes Restoration Initiative. The
Advisory Board also advises on domestic matters related to
implementation of the Great Lakes Water Quality Agreement between the
U.S. and Canada. The major objectives are to provide advice and
recommendations on: Great Lakes protection and restoration activities;
long-term goals, objectives, and priorities for Great Lakes protection
and restoration; and other issues identified by the Great Lakes
Interagency Task Force/Regional Working Group.

II. How do I participate in the remote public meeting?

A. Remote Meeting

    This meeting will be conducted as a virtual meeting on August 30th,
2021 from 1:00 p.m. to 4:00 p.m. Central Daylight Time and August 31st
from 9:00 a.m. to 12:00 p.m. Central Daylight Time. You must register
by 3:00 p.m. Central Daylight Time on August 23rd, 2021 to receive
information on how to participate. You may also submit written or oral
comments for the committee by following the processes outlined below.

B. Registration

    Individual registration is required for participation in this
meeting. Information on registration for this meeting can be found at
https://event.capconcorp.com/form/view.php?id=127543. When registering,
please provide your name, email, organization, city, and state. Please
also indicate whether you would like to provide oral and/or written
comments during the meeting at the time of registration.

C. Procedures for Providing Public Comments

    Oral Statements: In general, oral comments at this virtual
conference will be limited to the Public Comments portion of the
meeting agenda. Members of the public may provide oral comments limited
to up to three minutes per individual or group and may submit further
information as written comments. Persons interested in providing oral
statements should register at https://event.capconcorp.com/form/view.php?id=127543 for the meeting and indicate your interest to
provide public comments. Oral commenters will be provided an
opportunity to speak in the order in which their request was received
by the DFO and to the extent permitted by the number of comments and
the scheduled length of the meeting. Persons not able to provide oral
comments during the meeting will be given an opportunity to provide
written comments after the meeting.
    Written Statements: Persons interested in providing written
statements pertaining to this committee meeting may do so by indicating
at https://event.capconcorp.com/form/view.php?id=127543. Written
comments will be accepted before, during, and after the public meeting
and will be considered by the Great Lakes Advisory Board members.

D. Availability of Meeting Materials

    The meeting agenda and other materials for the virtual conference
will be posted on the GLAB website at www.glri.us/glab.

E. Accessibility

    Persons with disabilities who wish to request reasonable
accommodations to participate in this event may contact the DFO at
[email protected] or<PHONE_NUMBER> by 3:00 p.m. Central Daylight
Time on August 23rd, 2021. All final meeting materials will be posted
to the GLAB website in an accessible format following the meeting, as
well as a written summary of this meeting.

Cheryl Newton,
Acting Regional Administrator, Great Lakes National Program Manager.
[FR Doc. 2021-17326 Filed 8-12-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 27, 2010 (Volume 75, Number 186)]
[Notices]
[Page 59250-59252]
[DOCID:fr27se10-78]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

September 20, 2010.
    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG10-69-000.
    Applicants: Arizona Solar One LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Arizona Solar One LLC.
    Filed Date: 09/20/2010.
    Accession Number: 20100920-5119.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 12, 2010.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER06-560-010.
    Applicants: Credit Suisse Energy LLC.
    Description: Credit Suisse Energy LLC Notice of Non-Material Change
in Status.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5197.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER06-758-007; ER06-635-005; ER06-634-005; ER01-
2741-008; ER06-759-006; ER07-34-005; ER99-3320-008; ER95-1007-024.
    Applicants: Plains End, LLC, Chambers Cogeneration, Limited
Partnership, Edgecombe Genco, LLC, Logan Generating Company, L.P.,
Plains End II, LLC, Rathdrum Power, LLC, Selkirk Cogen Partners, L.P.,
Spruance Genco, LLC.
    Description: Chambers Cogeneration, Limited Partnership, et al.
Notice of Non-Material Change in Status.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5093.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2477-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits Supplement to Forward
Capacity Auction Results Filing.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5196.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2495-001.
    Applicants: Fulgora Arbitrage Fund, LLC.
    Description: Fulgora Arbitrage Fund, LLC submits tariff filing per
35.17(b): Supplement to Market-Based Rate Application of Fulgora
Arbitrage Fund, LLC to be effective 9/15/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5154.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2686-000.
    Applicants: West Penn Power Company.
    Description: The West Penn Power Company submits Certificate of
Concurrence with Allegheny Power's baseline Open Access Transmission,
Third Revised Volume No. 5, filed on September 16, 2010.
    Filed Date: 09/16/2010.
    Accession Number: 20100916-5158.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 07, 2010.

    Docket Numbers: ER10-2723-000.
    Applicants: Monongahela Power Company.
    Description: Monongahela Power Company submits tariff filing per
35.12: Allegheny Power Open Access Transmission Tariff Baseline Filing
to be effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5056.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2724-000.
    Applicants: El Paso Electric Company.
    Description: El Paso Electric Company submits tariff filing per
35.12: Baseline Filing of WestConnect Regional Experimental Tariff to
be effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5057.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2725-000.

    Applicants: Monongahela Power Company.
    Description: Monongahela Power Company submits tariff filing per
35.12: Monongahela Power Company Baseline Filing to be effective 9/17/
2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5058.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2726-000.
    Applicants: West Penn Power Company.
    Description: West Penn Power Company submits tariff filing per
35.12: West Penn Power Company Baseline Tariff filing to be effective
9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5059.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2727-000.
    Applicants: Allegheny Energy Supply Company, LLC.
    Description: Allegheny Energy Supply Company, LLC submits tariff
filing per 35.12: Allegheny Energy Supply Co. Baseline Filing to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5060.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2728-000.
    Applicants: Green Valley Hydro, LLC.
    Description: Green Valley Hydro, LLC submits tariff filing per
35.12: Green Valley Hydro, LLC Baseline Tariff filing to be effective
9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5061.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2729-000.
    Applicants: Buchanan Generation, LLC.
    Description: Buchanan Generation, LLC submits tariff filing per
35.12: Buchanan Generation, LLC Baseline Tariff to be effective 9/17/
2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5062.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2730-000.
    Applicants: El Paso Electric Company.
    Description: El Paso Electric Company submits tariff filing per
35.12: Baseline Filing of Open Access Transmission Tariff to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5063.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2731-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company's (SCE) Notice of
Cancellation of Letter Agreement SES LA-48.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5080.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2732-000.
    Applicants: Emera Energy Services, Inc.
    Description: Emera Energy Services, Inc. submits tariff filing per
35.12: Emera Energy Services MBR Tariff to be effective 9/20/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5089.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2733-000.
    Applicants: Emera Energy U.S. Subsidiary No. 1, Inc.
    Description: Emera Energy U.S. Subsidiary No. 1, Inc. submits
tariff filing per 35.12: Emera US Sub 1 MBR Tariff to be effective 9/
20/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5098.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2734-000.
    Applicants: Emera Energy U.S. Subsidiary No. 2, Inc.
    Description: Emera Energy U.S. Subsidiary No. 2, Inc. submits
tariff filing per 35.12: Emera U.S. Sub 2 MBR Tariff to be effective 9/
20/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5105.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2735-000.
    Applicants: Anthracite Power and Light Company.
    Description: Anthracite Power and Light Company submits tariff
filing per 35.12: Baseline Tariff Filing to be effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5110.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2736-000.
    Applicants: Emera Energy Services Subsidiary No. 1 LLC.
    Description: Emera Energy Services Subsidiary No. 1 LLC submits
Wholesale Market Based Rates Power Sales Tariff, to be effective 9/20/
2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5116.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2737-000.
    Applicants: Emera Energy Services Subsidiary No. 2 LLC.
    Description: Emera Energy Services Subsidiary No. 2 LLC submits
tariff filing per 35.12: EES Sub 2 MBR Tariff to be effective 9/20/
2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5117.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2738-000.
    Applicants: The Empire District Electric Company.
    Description: The Empire District Electric Company submits tariff
filing per 35.12: The Empire District Electric Company FERC Electric
Tariffs to be effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5118.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2739-000.
    Applicants: LS Power Marketing, LLC.
    Description: LS Power Marketing, LLC submits tariff filing per
35.12: Market-Based Rate Tariff in Compliance with Order No. 714 to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5119.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2740-000.
    Applicants: Rocky Road Power, LLC.
    Description: Rocky Road Power, LLC submits tariff filing per 35.12:
Market-Based Rate Tariff in Compliance with Order No. 714 to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5127.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2741-000.
    Applicants: Emera Energy Services Subsidiary No. 3 LLC.
    Description: Emera Energy Services Subsidiary No. 3 LLC submits
tariff filing per 35.12: EES Sub 3 MBR Tariff to be effective 9/20/
2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5128.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2742-000.
    Applicants: Tilton Energy, LLC.
    Description: Tilton Energy, LLC submits tariff filing per 35.12:
Market-Based Rate Tariff in Compliance with Order No. 714 to be
effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5135.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2743-000.
    Applicants: Bluegrass Generation Company, L.L.C.
    Description: Bluegrass Generation Company, L.L.C. submits tariff
filing per 35.12: Market-Based Rate Tariff in Compliance with Order No.
714 to be effective 9/17/2010.

    Filed Date: 09/17/2010.
    Accession Number: 20100917-5136.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2744-000.
    Applicants: Riverside Generating Company, L.L.C.
    Description: Riverside Generating Company, L.L.C. submits tariff
filing per 35.12: Market-Based Rate Tariff in Compliance with Order No.
714 to be effective 9/17/2010.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-5137.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Docket Numbers: ER10-2745-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM interconnection, LLC submits executed Wholesale
Market Participation Agreement with Space Energy Terrestrial, Inc et
al.
    Filed Date: 09/17/2010.
    Accession Number: 20100917-0210.
    Comment Date: 5 p.m. Eastern Time on Friday, October 08, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed 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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-24088 Filed 9-24-10; 8:45 am]
BILLING CODE 6717-01-P


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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes.. I have found that my personal e-cigarette usage has allowed me to quit smoking without even looking back, and am slowly tapering the nicotine levels down to 0.  Simply put, without access to these products I would still be smoking a pack of Marlboro Red’s per day.  My lungs feel better, my car smells nicer and I am more healthy than ever.

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so again

I appreciate your consideration of my request and am happy to discuss this issue with you further personally if you would like.

Thanks,

Joe


[Federal Register Volume 77, Number 109 (Wednesday, June 6, 2012)]
[Notices]
[Pages 33454-33455]
[FR Doc No: 2012-13697]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R04-OAR-2010-0017: FRL-9682-6]

Adequacy Status: South Carolina: Reasonable Further Progress Plan
Motor Vehicle Emissions Budget for Transportation Conformity for the
Portion of York County, South Carolina Within Charlotte-Gastonia-Rock
Hill, North Carolina-South Carolina; 1997 8-Hour Ozone Nonattainment
Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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

SUMMARY: In this notice, EPA is notifying the public of its finding
that the volatile organic compounds (VOC) motor vehicle emissions
budget (MVEB) for the portion of York County, South Carolina that is
within the Charlotte-Gastonia-Rock Hill, North Carolina-South Carolina
Area (hereafter referred to as the ``Charlotte bi-state Area'')
Reasonable Further Progress (RFP) plan for the 1997 8-hour ozone
National Ambient Air Quality Standard (NAAQS), submitted on August 31,
2007, and supplemented on April 29, 2010, by the South Carolina
Department of Health and Environmental Control (SC DHEC) are adequate
for transportation conformity purposes. The South Carolina portion of
the Charlotte bi-state Area is comprised of a portion of York County,
South Carolina. On March 2, 1999, the District of Columbia Circuit
Court ruled that submitted state implementation plans (SIPs) cannot be
used for transportation conformity determinations until EPA has
affirmatively found them adequate. As a result of EPA's finding, the
South Carolina portion of the Charlotte bi-state Area must use the VOC
MVEB from the submitted RFP plan supplement for the Area for future
conformity determinations.

DATES: This adequacy finding for VOC is effective June 21, 2012.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, U.S. Environmental
Protection Agency, Region 4, Air Planning Branch, Air Quality Modeling
and Transportation Section, 61 Forsyth Street SW., Atlanta, Georgia
30303. Ms. Sheckler can also be reached by telephone at<PHONE_NUMBER>,
or via electronic mail at<EMAIL_ADDRESS>The finding is
available at EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm

SUPPLEMENTARY INFORMATION: Today's notice is simply an announcement of
findings that EPA has already made.

EPA Region 4 sent a letter to SC DHEC on May 25, 2012, stating that the
2008 VOC MVEB in the 1997 8-hour ozone RFP plan for the South Carolina
portion of the Charlotte bi-state Area, dated August 31, 2007, and
supplemented on April 29, 2010, are adequate. EPA posted the
availability of the York County MVEB on EPA's Web site on May 13, 2010,
as part of the adequacy process, for the purpose of soliciting
comments. The comment period ran from May 13, 2010, through June 14,
2010. EPA's findings have also been announced on EPA's conformity Web
site: http://www.epa.gov/otaq/stateresources/index.htm, (once there,
click ``Transportation Conformity'' text icon, then look for ``Adequacy
Review of SIP Submissions''). The adequate VOC MVEB is provided in the
following table:

             York County, South Carolina 8-hr Ozone VOC MVEB
------------------------------------------------------------------------
                              2008                        2008
------------------------------------------------------------------------
                 York County ( partial county) VOC MVEB
------------------------------------------------------------------------
VOC..............  6.053 tons per day........  5,493 kilograms per day
------------------------------------------------------------------------

    Transportation conformity is required by section 176(c) of the
Clean Air Act, as amended in 1990. EPA's conformity rule, 40 CFR part
93, requires that transportation plans, programs and projects conform
to state air quality implementation plans and establishes the criteria
and procedures for determining whether or not they do. Conformity to a
SIP means that transportation activities will not produce new air
quality violations, worsen existing violations, or delay timely
attainment of the NAAQS.
    The criteria by which EPA determines whether a SIP's MVEB are
adequate for transportation conformity purposes are outlined in 40 CFR
93.118(e) (4). EPA has described the process for determining the
adequacy of submitted SIP budgets in a May 14, 1999, memorandum
entitled ``Conformity Guidance on Implementation of March 2, 1999
Conformity Court Decision.'' EPA has followed this guidance in making
this adequacy determination. This guidance is incorporated into EPA's
July 1, 2004, final rulemaking entitled ``Transportation Conformity
Rule Amendments for the New 8-hour Ozone and PM2.5 National
Ambient Air Quality Standards and Miscellaneous Revisions for Existing
Areas; Transportation Conformity
    Rule Amendments: Response to Court Decision and Additional Rule
Changes'' (See 69 FR 40004). Please note that an adequacy review is
separate from the EPA's completeness review, and it also should not be
used to prejudge EPA's ultimate approval of the SIP. Even if EPA finds
the MVEB adequate, the Agency may later disapprove the SIP.
    Within 24 months from the effective date of this notice, the
transportation partners will need to demonstrate conformity to the new
MVEB if the demonstration has not already been made, pursuant to 40 CFR
93.104(e). See 73 FR 4419 (January 24, 2008).

    Authority:  42 U.S.C. 7401 et seq.

    Dated: May 29, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2012-13697 Filed 6-5-12; 8:45 am]
BILLING CODE 6560-50-P


                                       TABLE OF CONTENTS FLORIDA
                PROGRAM REVISION AUTHORIZATION (PRA) APPLICATION for RCRA Cluster XXVIII - SPA 39
                                  July 1, 2019 through June 30, 2020
 Program Description for RCRA XXVIII	1

 Appendix A
RCRA Statutory Checklist dated December 30, 2005

 Appendix B
IBR Regulatory Documentation for Federal Provisions for which Florida is Seeking Authorization:

Checklist in RCRA Cluster XXVIII
             Checklist 242, Universal Waste Regulations: Addition of Aerosol Cans

 Appendix C
       Coded Rules 62-730.020, 62-730.030, 62-730.180, 62-730.183, 62-730.185, 62-730.220, Florida Administrative Code (F.A.C.), filed with  the Department of State on October 30, 2020.

 Appendix D
Chapter 62-730, F.A.C., effective October 30, 2020

 Appendix E
Memorandum of Agreement between the State of Florida Department of Environmental Protection and the United States Environmental Protection Agency Region 4  -  effective February 19, 2016

 Appendix F
 FDEP Organization Charts  -  July 1, 2021


[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Page 29976]
[FR Doc No: 2017-13721]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2017-53]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, this aspect of the FAA's regulatory activities.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before July 20, 2017.

ADDRESSES: Send comments identified by docket number FAA-2017-0259
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Lynette Mitterer, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>; or Alphonso
Pendergrass, ARM-200, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Renton, Washington.
Victor Wicklund,
Manager, Transport Standards Staff.

Petition for Exemption

    Docket No.: FAA-2017-0259.
    Petitioner: The Boeing Company.
    Section of 14 CFR Affected: Sec.  25.813(e).
    Description of Relief Sought: Allow doors between passenger
compartments, for the sole purpose of installing mini-suites in the
premium cabin of Boeing Model 777 airplanes.

[FR Doc. 2017-13721 Filed 6-29-17; 8:45 am]
 BILLING CODE 4910-13-P