[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Pages 57958-57959]
[FR Doc No: 2023-18241]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3499]

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Alternative Form of Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of alternative form of hearing.

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SUMMARY: The Food and Drug Administration (FDA) announces an
alternative form of hearing regarding the Center for Drug Evaluation
and Research's (CDER's) proposal to refuse to approve ITCA 650
(exenatide in DUROS device), a drug-device combination product that is
the subject of a new drug application (NDA) submitted by Intarcia
Therapeutics, Inc. (Intarcia). CDER is holding a public hearing before
an advisory committee under FDA regulations as an alternative form of
hearing.

DATES: The meeting will be held virtually on September 21, 2023, from 9
a.m. to 5:30 p.m. Eastern Time.

ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. Answers to
commonly asked questions including information regarding special
accommodations due to a disability may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2855, email: [email protected]; or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area).

SUPPLEMENTARY INFORMATION:
    Background: This advisory committee meeting is being held pursuant
to a March 24, 2023, letter from the Chief Scientist of FDA, Dr.
Namandj[eacute] N. Bumpus, wherein she granted Intarcia's request under
Sec.  12.32(b)(3)(ii) (21 CFR 12.32(b)(3)(ii)) for a public hearing
before an advisory committee in lieu of a formal evidentiary public
hearing under part 12 (21 CFR part 12).
    Intarcia submitted NDA 209053 for ITCA 650 (exenatide in DUROS
device), a novel drug-device combination product on November 21, 2016,
under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(b)(1)). On September 21, 2017, CDER issued a
complete response (CR) letter to Intarcia under Sec.  314.110(a) (21
CFR 314.110(a)) stating that NDA 209053 could not be approved in its
present form, describing the specific deficiencies and, where possible,
recommending ways that Intarcia might remedy these deficiencies. On
September 9, 2019, Intarcia resubmitted the NDA under section 505(b)(1)
of the FD&C Act. On March 9, 2020, CDER issued a second CR letter
stating that NDA 209053 could not be approved in its present form,
describing the specific deficiencies and, where possible, recommending
ways that Intarcia might remedy these deficiencies. The CR letters
stated that Intarcia is required either to resubmit the application,
fully addressing all deficiencies listed in the letter, or take other
actions available under Sec.  314.110 (i.e., resubmit the application,
withdraw the application, or request an opportunity for a hearing).
Applicable regulations, including 21 CFR 10.75, also provide a
mechanism for applicants to obtain formal review of one or more
decisions reflected in a CR letter.
    On March 16, 2021, Intarcia submitted a request under Sec.
314.110(b)(3) for an opportunity for a hearing on whether there are
grounds under section 505(d) of the FD&C Act for denying approval of
NDA 209053. In the Federal Register of September 2, 2021, FDA published
a notice of opportunity for a hearing (NOOH) regarding CDER's proposal
to refuse to approve NDA 209053 submitted by Intarcia for ITCA 650 (86
FR 49334). The NOOH gave Intarcia an opportunity to request a hearing
before the Commissioner of Food and Drugs on CDER's proposal to refuse
to approve NDA 209053. On September 13, 2021, Intarcia submitted a
notice of participation and request for a hearing. Intarcia submitted
data, information, and analyses in support of its hearing request on
November 1, 2021, and February 15, 2022.
    On July 29, 2022, CDER issued, via email to Intarcia, a proposed
order proposing to refuse to approve NDA 209053 in its present form
(see Docket No. FDA-2021-N-0874). Intarcia responded to CDER's proposed
order on October 10, 2022.
    On February 7, 2023, the Chief Scientist of FDA issued a letter to
Intarcia and CDER that stated, in part: ``Under 21 CFR 12.32(a), a
person seeking a hearing under 21 CFR part 12 may request an
alternative form of hearing, such as a hearing before a public advisory
committee under 21 CFR part 14.'' Dr. Bumpus stated that she would
grant a request from Intarcia for an alternative form of hearing under
part 14 (21 CFR part 14) in lieu of a formal evidentiary hearing under
part 12. On February 20, 2023, Intarcia submitted a request in the form
of a citizen petition under 21 CFR 10.30, requesting a public hearing
before an advisory committee under part 14 in lieu of Intarcia's
pending request for a formal evidentiary hearing under part 12. On
March 24, 2023, Dr. Bumpus issued a letter granting Intarcia's request
for an alternative form of hearing.
    Accordingly, CDER is holding this meeting pursuant to the March 24,
2023, letter from Dr. Bumpus, wherein she granted Intarcia's request
under Sec.  12.32(b)(3)(ii) for a public hearing before an advisory
committee in lieu of a formal evidentiary hearing. This document serves
as the notice of an alternative form of hearing as required under Sec.
12.32(e).
    Subject of Alternative Form of Hearing: CDER's proposed order to
refuse to approve ITCA 650 (exenatide in DUROS device) is the subject
of the alternative form of hearing before the Endocrinologic and
Metabolic Drugs Advisory Committee (see Docket No. FDA-2021-N-0874).
    Parties to the Alternative Form of Hearing: Intarcia Therapeutics,
Inc. and the Center for Drug Evaluation and Research are the parties to
the alternative form of hearing before the Endocrinologic and Metabolic
Drugs Advisory Committee.
    Issues To Be Discussed: The issues presented at the hearing will be
those related to the safety and efficacy of ITCA 650, a drug-device
combination product that is the subject of an NDA submitted by Intarcia
(NDA 209053), for the proposed indication, as an adjunct to diet and
exercise, to improve glycemic control in adults with type 2 diabetes
mellitus.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by

this waiver, and that the ends of justice will be served by allowing
for this modification to FDA's advisory committee meeting procedures.

    Dated: August 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18241 Filed 8-23-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37109-37110]
[FR Doc No: 2011-15857]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-18-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of
Availability of the Environmental Assessment for the Proposed Mid-South
Expansion Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the Mid-
South Expansion Project proposed by Transcontinental Gas Pipe Line
Company, LLC (Transco) in the above-referenced docket. Transco requests
authorization to construct and operate five new pipeline loops,\1\
construct one new compressor station, add compression at two existing
compressor stations, and perform other modifications to five compressor
stations. The MSEP would provide about 451 million standard cubic feet
of natural gas per day to Transco's existing mainline system from the
Clean Energy LNG import terminal currently under construction in
Pascagoula, Mississippi, with existing capacity on Transco's Mobile Bay
Lateral, down to existing Compressor Station 85. According to Transco,
its project would expand delivery capacity on its existing pipeline
system to growing markets in the east as far downstream as Rockingham
County, North Carolina.
---------------------------------------------------------------------------

    \1\ A pipeline loop is constructed parallel to an existing
pipeline to increase capacity.
---------------------------------------------------------------------------

    The EA assesses the potential environmental effects of the
construction and operation of the Mid-South Expansion Project in
accordance with the requirements of the National Environmental Policy
Act of 1969 (NEPA). The FERC staff concludes that approval of the
proposed project, with appropriate mitigating measures, would not
constitute a major Federal action significantly affecting the quality
of the human environment.
    The proposed Mid-South Expansion Project includes the following
facilities:
     Five pipeline loops located in Coosa and Randolph
Counties, Alabama, and Gaston, Rowan and Davidson Counties, North
Carolina;
     One new compressor station, Station 95, to be located in
Dallas County, Alabama;
     Additional new compression at two existing compressor
stations:
    [cir] Station 90 in Marengo County, Alabama; and
    [cir] Station 125 in Walton County, Georgia;

     Modifications at the following existing compressor
stations:
    [cir] Station 105 in Coosa County, Alabama;
    [cir] Station 115 in Coweta County, Georgia;
    [cir] Station 120 in Henry County, Georgia;
    [cir] Station 140 in Spartanburg County, South Carolina; and
    [cir] Station 145 in Cleveland County, North Carolina.
    The planned loops would be constructed with 42-inch-diameter steel
pipe and would have a combined total length of about 22.6 miles.
    The EA has been placed in the public files of the FERC and is
available for public viewing on the FERC's Web site at http://www.ferc.gov using the eLibrary link. A limited number of copies of the
EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street,
NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Copies of the EA have been mailed to Federal, State, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; newspapers and libraries in the project area; and parties to
this proceeding.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that your comments are properly recorded and considered prior to
a Commission decision on the proposal, it is important that the FERC
receives your comments in Washington, DC on or before July 20, 2011.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
project docket number (CP11-18-000) with your submission. The
Commission encourages electronic filing of comments and has dedicated
eFiling expert staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at http://www.ferc.gov under the link to Documents and Filings. An eComment is an
easy method for interested persons to submit brief, text-only comments
on a project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at http://www.ferc.gov under the link to Documents and Filings. With eFiling, you
can provide comments in a variety of formats by attaching them as a
file with your submission. New eFiling users must first create an
account by clicking on ``eRegister.'' You will be asked to select the
type of filing you are making. A comment on a particular project is
considered a ``Comment on a Filing''; or
    (3) You may file a paper copy of your comments at the following
address: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Room 1A, Washington, DC 20426.
    Although your comments will be considered by the Commission, simply
filing comments will not serve to make the commenter a party to the
proceeding. Any person seeking to become a party to the proceeding must
file a motion to intervene pursuant to Rule 214 of the Commission's
Rules of Practice and Procedures (18 CFR 385.214).\2\ Only intervenors
have the right to seek rehearing of the Commission's decision.
---------------------------------------------------------------------------

    \2\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
---------------------------------------------------------------------------

    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your comments considered.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC or on the
FERC Web site (http://www.ferc.gov) using the eLibrary link. Click on
the eLibrary link, click on ``General Search'' and enter the docket
number excluding the last three digits in the Docket Number field
(i.e., CP11-18-000). Be sure you have selected an appropriate date
range. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.

    Dated: June 20, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-15857 Filed 6-23-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Rules and Regulations]
[Pages 50477-50479]
[FR Doc No: 2018-21466]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0451; Product Identifier 2017-NM-172-AD; Amendment
39-19406; AD 2018-19-06]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Dassault Aviation Model FALCON 900EX airplanes. This AD was prompted by
reports of rejected take-offs due to untimely inboard flap retraction.
This AD requires modification of the slat/flap control wiring and
replacement of the slat/flap control box with an improved box. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective November 13, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 13,
2018.

ADDRESSES: For service information identified in this final rule,
contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box
2000, South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet
http://www.dassaultfalcon.com. You may view this service information at
the FAA, Transport Standards Branch, 2200

South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available on
the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2018-0451.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0451; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenues SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Dassault Aviation
Model FALCON 900EX airplanes. The NPRM published in the Federal
Register on May 30, 2018 (83 FR 24686). The NPRM was prompted by
reports of rejected take-offs due to untimely inboard flap retraction.
The NPRM proposed to require modification of the slat/flap control
wiring and replacement of the slat/flap control box with an improved
box.
    We are issuing this AD to address an uncommanded retraction of the
inboard slats and flaps during take-off, and consequent reduced
controllability of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2017-0219, dated November 14, 2017 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Dassault Aviation Model FALCON
900EX airplanes. The MCAI states:

    An occurrence was reported where, during the take-off run, a red
CAS [crew alerting system] message ``NO TAKE OFF'' was displayed,
and an aural warning was given. The flight crew elected to abort the
take-off. The configuration of the affected aeroplane was SF1 and
indicated airspeed (IAS) was at 100 kts. Investigations showed that
the outboard slat extended microswitch, located at track #7, was not
correctly adjusted. A design review revealed that this deficiency
may affect only Falcon 900LX (commercial designation) without
modification M5636, during take-off in SF1 configuration.
    This condition, if not corrected, could lead to an uncommanded
retraction of inboard slats and flaps during take-off, possibly
resulting in reduced control of the aeroplane.
    To address this potential unsafe condition, DA [Dassault
Aviation] designed modification M6043 and published Service Bulletin
(SB) F900EX-522 to provide instructions for embodiment of this
modification in-service.
    For the reasons described above, this [EASA] AD requires a
wiring modification and replacement of the slat/flap control box
with an improved box.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0451.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We received no comments on the NPRM or on the
determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this final rule as proposed,
except for minor editorial changes. We have determined that these minor
changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Dassault Aviation has issued Dassault Aviation Service Bulletin
F900EX-522, also referred to as 522, dated March 8, 2017. This service
information describes procedures for modifying the slat/flap control
wiring and replacing the slat/flap control box. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 13 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Modification and replacement..........  22 work-hours x $85 per           $8,495         $10,365        $134,745
                                         hour = $1,870.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all known costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the

Compliance and Airworthiness Division, but during this transition
period, the Executive Director has delegated the authority to issue ADs
applicable to transport category airplanes and associated appliances to
the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-19-06 Dassault Aviation: Amendment 39-19406; Docket No. FAA-
2018-0451; Product Identifier 2017-NM-172-AD.

(a) Effective Date

    This AD is effective November 13, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Dassault Aviation Model FALCON 900EX
airplanes, certificated in any category, serial number 240 and
serial numbers 242 through 273 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Reason

    This AD was prompted by reports of rejected take-offs due to
untimely inboard flap retraction. We are issuing this AD to address
an uncommanded retraction of the inboard slats and flaps during
take-off, and consequent reduced controllability of the airplane.

(f) Compliance

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

(g) Modification and Replacement

    Within 500 flight hours after the effective date of this AD,
modify the slat/flap control wiring and replace the slat/flap
control box having part number (P/N) 6-7061 with an improved control
box, in accordance with the Accomplishment Instructions of Dassault
Aviation Service Bulletin F900EX-522, also referred to as 522, dated
March 8, 2017.

(h) Parts Installation Prohibition

    After modification of an airplane as required by paragraph (g)
of this AD, no person may install any slat/flap control box having
P/N 6-7061 on that airplane.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2017-0219, dated November 14, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0451.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Dassault Aviation Service Bulletin F900EX-522, also referred
to as 522, dated March 8, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet http://www.dassaultfalcon.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on August 30, 2018.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2018-21466 Filed 10-5-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Rules and Regulations]
[Pages 62003-62006]
[FR Doc No: 2014-24340]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2014-0629; FRL-9917-69-Region-3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; State Boards Requirements

AGENCY: Environmental Protection Agency.

ACTION: Direct Final Rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a revision to the Commonwealth of Pennsylvania
State Implementation Plan (SIP). The SIP revision addresses the State
Boards' requirements for all criteria pollutants of the National
Ambient Air Quality Standards (NAAQS). EPA is also approving a related
infrastructure element from Pennsylvania's September 24, 2012 SIP
submittal for the 2008 Lead NAAQS. EPA is approving this SIP revision
in accordance with the requirements of the Clean Air Act (CAA).

DATES: This rule is effective on December 15, 2014 without further
notice, unless EPA receives adverse written comment by November 17,
2014. If EPA receives such comments, it will publish a timely
withdrawal of the direct final rule in the Federal Register and inform
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2014-0629 by one of the following methods:
    A. www.regulations.gov. Follow the online instructions for
submitting comments.
    B. E-Mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2014-0629, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Air Protection Division,
Mailcode 3AP30, U.S. Environmental Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2014-0629. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at 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 information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
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 email
comment directly to EPA without going through www.regulations.gov, your
email 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
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 www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the Commonwealth's
submittal are available at the Pennsylvania Department of Environmental
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Ruth Knapp,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 128 of the CAA requires SIPs to comply with the
requirements regarding State Boards. Section 110(a)(2)(E)(ii) of the
CAA also references these requirements. Section 128(a) of the CAA
requires SIPs to contain provisions that: (1) Any board or body which
approves permits or enforcement orders under the CAA shall have at
least a majority of its members represent the public interest and not
derive any significant portion of their income from persons subject to
permits or enforcement orders under the CAA; and (2) any potential
conflict of interest by members of such board or body or the head of an
executive agency with similar powers be adequately disclosed. The
requirements of section 128(a)(1) are not applicable to Pennsylvania
because it does not have any board or body which approves air quality
permits or enforcement orders. The requirements of section 128(a)(2),
however, are applicable because the heads of the Pennsylvania
Department of Environmental Protection (PADEP), the Allegheny County
Health Department (ACHD), and Philadelphia Air Management Services
(AMS), or their designees, approve permits or enforcement orders within
Pennsylvania.
    On July 15, 2014, the Commonwealth of Pennsylvania, through PADEP,
submitted a SIP revision to address the requirements of sections 128
and 110(a)(2)(E)(ii) for all criteria pollutants of the NAAQS in
relation to State Boards. This submission addressing sections 128 and
110(a)(2)(E)(ii) for all NAAQS was part of a larger SIP revision
submitted on the same date which addresses requirements in section
110(a) for the 2008 ozone NAAQS; however, EPA will take later separate
rulemaking action on the remainder of that July 15, 2014 SIP
submission.
    Previously, on September 24, 2012, Pennsylvania submitted a SIP
revision to satisfy several requirements of section 110(a)(2) of the
CAA for the 2008 Lead NAAQS. On April 7, 2014, EPA published a Final
Rulemaking Notice in which EPA approved certain elements of
Pennsylvania's SIP submittal for the 2008 Lead NAAQS and stated that
EPA would take separate action on the submittal as it related to
requirements in sections 110(a)(2)(E)(ii) and 128 of the CAA. 79 FR
19009.

II. Summary of SIP Revision

    This rulemaking action approves certain statutory provisions for
the Pennsylvania SIP submitted by PADEP to meet the requirements of
section 128 of the CAA. Upon meeting the requirements of section 128,
Pennsylvania will also meet the requirements of section
110(a)(2)(E)(ii) of the CAA for all criteria pollutants of the NAAQS in
relation to State Boards.
    Pennsylvania's statutory provisions governing the relevant section
128 requirements are in Chapter 11 of the Pennsylvania Public Official
and Employee Ethics Act (PA Ethics Act), found at 65 Pa.C.S. sections
1101-1109. The Secretary of PADEP and heads of ACHD and AMS, as well as
the state employees subordinate to those positions, are subject to the
requirements of Chapter 11 of the PA Ethics Act. In order to meet the
requirements of CAA sections 128 and 110(a)(2)(E)(ii), Pennsylvania is
seeking to incorporate into the SIP the relevant provisions of Chapter
11 of the PA Ethics Act, including certain relevant portions of
sections 1101, 1102, 1104, 1105, and 1109. The Commonwealth's effective
dates for these sections of Chapter 11 will be listed in the table in
40 CFR 52.2020(c).

III. EPA's Analysis of Pennsylvania's SIP Revision

    Sections 128 and 110(a)(2)(E)(ii) require that each state's SIP
demonstrate how state boards, bodies or heads of executive agencies
which approve CAA permits or enforcement orders disclose any potential
conflicts of interest. The Secretary of PADEP and heads of ACHD and
AMS, or their designees, approve all CAA permits and enforcement orders
in Pennsylvania. All three agencies are executive agencies that act
through their respective Secretary, head, or delegated subordinate
state or local employees. Pennsylvania submitted relevant provisions of
Chapter 11 of the PA Ethics Act for inclusion into the SIP as required
by sections 128 and 110(a)(2)(E)(ii). Chapter 11 of the PA Ethics Act
applies to public officials and employees and requires them to disclose
relevant financial information including direct and indirect financial
interests, income and gifts. This SIP revision will incorporate
existing Pennsylvania law into the SIP and demonstrates that
Pennsylvania complies with the requirements of sections 128 and
110(a)(2)(E)(ii) of the CAA for all NAAQS pollutants through the
relevant sections of Chapter 11 of the PA Ethics Act for adequate
disclosure of potential conflicts of interest.

IV. Final Action

    EPA is approving the portion of the July 15, 2014 Pennsylvania SIP
revision that addresses the requirements of sections 128 and
110(a)(2)(E)(ii) of the CAA for all criteria pollutants of the NAAQS.
EPA is also specifically approving Pennsylvania's September 24, 2012
SIP revision for the 2008 Lead NAAQS as addressing the requirements in
section 110(a)(2)(E)(ii) of the CAA. EPA is publishing this rule
without prior proposal because EPA views this as a noncontroversial
amendment and anticipates no adverse comment. However, in the
``Proposed Rules'' section of today's Federal Register, EPA is
publishing a separate document that will serve as the proposal to
approve the SIP revision if adverse comments are filed. This rule will
be effective on December 15, 2014 without further notice unless EPA
receives adverse

comment by November 17, 2014. If EPA receives adverse comment, EPA will
publish a timely withdrawal in the Federal Register informing the
public that the rule will not take effect. EPA will address all public
comments in a subsequent final rule based on the proposed rule. EPA
will not institute a second comment period on this action. Any parties
interested in commenting must do so at this time. Please note that if
EPA receives adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, EPA may adopt as final those provisions of the rule that are
not the subject of an adverse comment.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 15, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking action. This action, approving the Pennsylvania SIP revision
for purposes of meeting sections 128 and 110(a)(2)(E)(ii) requirements
for all criteria pollutants of the NAAQS in relation to State Boards,
may not be challenged later in proceedings to enforce its requirements.
(See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements.

    Dated: September 23, 2014.
William C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020:
0
a. The table in paragraph (c)(1) is amended by adding a new section for
``Title 65 Pennsylvania Statute--Public Officers, Part II--
Accountability, Chapter 11--Ethics Standards and Financial
Disclosure,'' before the section for Title 67, with new entries for
sections 1101, 1102, 1104, 1105, and 1109.
0
b. The table in paragraph (e)(1) is amended by revising the entry for
``Section 110(a)(2) Infrastructure Requirements for the 2008 Pb
NAAQS.''
    The additions and revisions read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (c) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                                                                Additional
          State citation              Title/subject          State       EPA approval date    explanation/  Sec.
                                                        effective date                         52.2063 citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                 Title 65 Pennsylvania Statute--Public Officers
                                             Part II--Accountability
                             Chapter 11--Ethics, Standards, and Financial Disclosure
----------------------------------------------------------------------------------------------------------------
Section 1101.....................  Short title of             12/14/98  10/16/14 [Insert     Addresses CAA
                                    chapter.                             Federal Register     section 128.
                                                                         citation].
Section 1102.....................  Definitions........          1/1/07  10/16/14 [Insert     Addresses CAA
                                                                         Federal Register     section 128.
                                                                         citation].
Section 1104.....................  Statement of               12/14/98  10/16/14 [Insert     Addresses CAA
                                    financial                            Federal Register     section 128.
                                    interests required                   citation].
                                    to be filed.
Section 1105.....................  Statement of                 1/1/07  10/16/14 [Insert     Addresses CAA
                                    financial                            Federal Register     section 128.
                                    interests.                           citation].
Section 1109.....................  Penalties..........        12/14/98  10/16/14 [Insert     Addresses CAA
                                                                         Federal Register     section 128.
                                                                         citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
    Name of non-regulatory SIP          Applicable           State                                Additional
             revision                geographic area    submittal date   EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 110(a)(2) Infrastructure   Statewide..........         5/24/12  4/7/2014, 79 FR      This rulemaking
 Requirements for the 2008 Pb                                            19001.               action addresses
 NAAQS.                                                                                the following CAA
                                                                                elements:
                                                                                110(a)(2)(A), (B),
                                                                                (C), (D)(i)(I),
                                                                                (D)(i)(II),
                                                                                (D)(ii), (E)(i),
                                                                                (E)(iii), (F),
                                                                                (G), (H), (J),
                                                                                (K), (L), and (M).
                                                               7/15/14  10/16/14 [Insert     This rulemaking
                                                                         Federal Register     action addresses
                                                                         citation].           the following CAA
                                                                                elements:
                                                                                110(a)(2)(E)(ii).
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-24340 Filed 10-15-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7547-7548]
[FR Doc No: 2016-02887]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0148]

Government-Owned Inventions; Availability for Licensing;
Influenza Virus Neuramindase

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The invention listed in this document is owned by an Agency of
the U.S. Government and is available for licensing in accordance with
Federal regulations to achieve expeditious commercialization of results
of Federally funded research and development.

FOR FURTHER INFORMATION CONTACT:
    For licensing information and copies of the patent applications:
Alice Welch, Technology Transfer Program Office, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4226, Silver
Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>. A signed
Confidential Disclosure Agreement will be required to receive copies of
the patent applications.
    For parties interested in licensing or collaborative research
activities: William Ronnenberg, Technology Transfer Program Office,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm.
4214, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Technology description.
    Title of Abstract: Therapeutic and prophylactic anti-Influenza
virus neuraminidase 1 (N1) antibody (CD6) with a novel epitope that
spans neuramindase (NA) dimers.
    Description of Technology: Influenza virus neuramindase (NA)
protein is a surface protein that plays an essential role in virus
replication. Drugs and antibodies that block NA function can reduce
both the symptoms and the length of illness; however, variants of
influenza virus are resistant to NA inhibitors. The neuramindase 1 (N1)
subtype of NA is important because it is found in the two pandemic H1N1
influenza virus strains (1918 Spanish flu and 2009 swine flu) and the
H5N1 avian influenza virus. Anti-neuramindase antibody CD6 is a novel
antibody that spans a conserved 30 amino acid epitope across the
lateral face of a neuramindase (NA) dimer.
    The subject technology may offer an alternative to therapeutic NA
inhibitors

currently available. CD6 is a potent monoclonal antibody against N1
subtypes of NA that inhibits the enzymatic activity of the NA protein,
including NA variants resistant to NA inhibitors. In a murine model of
infection, a single dose of antibody was protective against lethal
challenge with H1N1 influenza virus. The CD6 antibody can potentially
be used in combination with other antibodies in an antibody
``cocktail'' or in conjunction with other therapeutic agents.
Additionally, this unique anti-NA antibody may be useful in combination
with known neutralizing anti-hemagglutinin (HA) antibodies.

Potential Commercial Applications

     Prophylactic and therapeutic against influenza virus
infections;
     Diagnostic tests for influenza virus infections; and
     Reagent to measure the potency of H1N1 NA in influenza
virus vaccines.

Competitive Advantages

     Monoclonal antibody demonstrated to be effective against
circulating H1N1 influenza viruses;
     Monoclonal antibody binds a novel, conserved epitope
spanning NA dimers; and
     Monoclonal antibody is well-suited for an antibody
cocktail that includes anti-HA antibodies.
    Development Stage: Early state; In vitro data available; In vivo
data available (animal).
    Inventors: Hongquan Wan (FDA); Maryna Eichelberger (FDA); Hua Yang
(CDC); James Stevens (CDC); David Shore (CDC); and Rebecca Garten
(CDC).
    Publication: Wan, H., H. Yang, D. A. Shore, R. J. Garten, L.
Couzens, J. Gao, L. Jiang, P. J. Carney, J. Villanueva, J. Stevens, and
M. C. Eichelberger. ``Structural Characterization of a Protective
Epitope Spanning A(H1N1)pdm09 Influenza Virus Neuraminidase Monomers.''
6:6114, Nature Communications, 2015.
    Intellectual Property: HHS Reference No. E-005-2015/0--U.S.
Provisional Patent Application No. 62/088,388 filed December 5, 2014.
    Licensing and Collaborative Research Opportunity: The invention is
owned by an Agency of the U.S. Government and is available for
licensing in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    The Food and Drug Administration is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Parties interested in licensing or collaborative research
activities for this technology should contact William Ronnenberg (see
FOR FURTHER INFORMATION CONTACT).

    Dated: February 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02887 Filed 2-11-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Page 42341]
[FR Doc No: 2016-15279]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-1888-000]

Tidal Energy Marketing Inc.; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Tidal Energy Marketing Inc.'s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 11, 2016.
    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
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: June 20, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-15279 Filed 6-28-16; 8:45 am]
 BILLING CODE 6717-01-P


-----Forwarded by Lydia Wegman/RTP/USEPA/US on 03/11/2008 06:06PM -----

To: Jason Burnett/DC/USEPA/US@EPA, Fraas Art

From: Karen Martin/RTP/USEPA/US

Date: 03/11/2008 05:37PM

cc: Wegman Lydia@EPA, Steve Page/RTP/USEPA/US@EPA, Vicki
Sandiford/RTP/USEPA/US@EPA

Subject: Draft responses to comments on ozone secondary

We are still doing some further edits to these responses, but this is
close to final.  One file contains the science/policy comments and the
other file addresses legal/procedural comments.

Karen Martin, Ph.D.

Office of Air Quality Planning and Standards

U.S. EPA (C504-06)

Research Triangle Park, NC 27711

phone:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

<EMAIL_ADDRESS>