[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Rules and Regulations]
[Page 35043]
[FR Doc No: 2014-14399]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0403]

Drawbridge Operation Regulation; China Basin, San Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the 3rd Street Drawbridge across China
Basin, mile 0.0, at San Francisco, CA. The deviation is necessary to
allow the public to cross the bridge to participate in the scheduled
San Francisco Marathon, a community event. This deviation allows the
bridge to remain in the closed-to-navigation position during the
deviation period.

DATES: This deviation is effective from 6 a.m. to 2:30 p.m. on July 27,
2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0403], is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on the
line associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Cheryl Collins, Program Manager, Docket Operations, telephone 202-
366-9826.

SUPPLEMENTARY INFORMATION: The City of San Francisco Public Works
Department has requested a temporary change to the operation of the 3rd
Street Drawbridge, mile 0.0, over China Basin, at San Francisco, CA.
The drawbridge navigation span provides 7 feet vertical clearance above
Mean High Water in the closed-to-navigation position. The draw opens on
signal if at least one hour notice is given as required by 33 CFR
117.149. Navigation on the waterway is recreational.
    The drawspan will be secured in the closed-to-navigation position
from 6 a.m. to 2:30 p.m. on July 27, 2014 to allow the public to cross
the bridge to participate in the scheduled San Francisco Marathon. This
temporary deviation has been coordinated with the waterway users. No
objections to the proposed temporary deviation were raised. The
drawspan can be operated upon one hour advance notice for emergencies
requiring the passage of waterway traffic.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will be able to open for emergencies upon
one hour advance notice and there is no immediate alternate route for
vessels to pass. The Coast Guard will also inform the users of the
waterways through our Local and Broadcast Notices to Mariners of the
change in operating schedule for the bridge so that vessels can arrange
their transits to minimize any impact caused by the temporary
deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: May 30, 2014.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2014-14399 Filed 6-18-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35429-35430]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2019-15673]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Thursday, July 25, 2019.

PLACE: The meeting will be held at the Commission's headquarters, 100 F
Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov/.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matters of the closed meeting will consist of the
following topics:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFO: For further information; please contact
Vanessa A. Countryman from the Office of the Secretary at (202) 551-
5400.

    Dated: July 18, 2019.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2019-15673 Filed 7-19-19; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Page 15863]
[FR Doc No: 2018-07599]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3396-EM; Docket ID FEMA-2018-0001]

California; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of California (FEMA-3396-EM), dated December 8, 2017, and
related determinations.

DATES: This amendment was issued April 3, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective December 29, 2017.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-07599 Filed 4-11-18; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: December 4, 2007 (Volume 72, Number 232)]
[Notices]
[Page 68154-68155]
[DOCID:fr04de07-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12910-000]

BPUS Generation Development, LLC; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene, Protests, and Comments

November 26, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12910-000.
    c. Date filed: July 30, 2007.
    d. Applicant: BPUS Generation Development, LLC.
    e. Name of Project: Maxwell Lock & Dam Hydroelectric Project.
    f. Location: Monongahela River in Washington and Fayette counties,
Pennsylvania. It would use the U.S. Army Corps of Engineers' Maxwell
Lock & Dam.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Jeffrey M. Auser, P.E., BPUS Generation
Development, LLC, 225 Greenfield Parkway, Suite 201, Liverpool, NY
13088,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and interventions may be
filed electronically via the Internet in lieu of paper; see 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings. Please include the project number (P-12910-000) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project using the U.S. Army
Corps of Engineers' Maxwell Lock & Dam and operated in a run-of-river
mode would consist of: (1) A new 60-foot long, 110-foot wide, 40-foot
high concrete powerhouse; (2) a new intake channel and tailrace channel
in the last spillway bay on the east side of the river; (3) two
turbine/generator units with a combined installed capacity of 10
megawatts; (4) a new 13,100-foot long above ground transmission line
extending from the switchyard near the powerhouse to an interconnection
point with an existing transmission line located northeast of the
powerhouse; and (5) appurtenant facilities. The proposed Maxwell Lock &
Dam Project would have an average annual generation of 71.6 gigawatt-
hours.
    l. This filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for inspection and reproduction at the address in
item h above.
    m. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    n. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    o. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    p. Proposed Scope of Studies Under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    q. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    r. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    s. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-23441 Filed 12-3-07; 8:45 am]

BILLING CODE 6717-01-P


Aaron:

History is always harder to reconstruct and explain than expected, so this has taken a bit longer that I had hoped given all of the other activities going on.  I hope that my answers below will inform your decision making process for the RH FIP in Montana.

As I noted during our call, Ash Grove formally commented on the EPA's assertions related to transferability of SNCR performance results from one long wet kiln to another based on the data from Midlothian's three wet kilns at the time.  We continue to believe that the data affirms our comments and experience at Montana. While we cannot confirm the uncontrolled NOx emissions at Montana due to an obligation to operate SNCR at all times, we believe that uncontrolled NOx rates being experienced now are lower than previously observed due to our efforts to optimize kiln operations through the mandated consent decree "test and set" process.  Bear in mind that part of that process has involved the installation of new, certified, CEMS in the stack, where previously the uncertified CEMs were located in the smoke box.  We do not believe it has been demonstrated that 50% control can be achieved on any long kiln thru the use of SNCR alone. Many variables exist when comparing one kiln or kiln feed mix chemistry to another. My comment letter of June 19, 2012 provides further detail on this, but the concluding paragraph is below:       In summary, we continue to believe that an SNCR system at Montana City cannot be assumed to reach greater than 35 percent control efficiency and that EPA has produced no credible evidence in the record for supporting a different conclusion. While we recognize that our initial BART submittal listed 50 percent control as achievable for the combination of a low NOx burner and SNCR at the Montana City kiln, based on the actual operating results we have achieved at Midlothian since 2006/2007, we can no longer be confident that 50 percent is achievable at Montana City since we cannot get to that level on all three kilns at Midlothian. ...

I understand your interest in ammonia CEMS information, but you should realize that pretty significant advances have been made since 2007 in that arena.  While our monitors for the old kiln stacks at Midlothian were the latest technology at the time, they were difficult to maintain due to stack optical path length variability (caused by temperature changes and its impact on alignment), significant stack gas moisture content (wet process kilns have higher moisture stack gas), and lack of reliable support from the CEM manufacturer.  It should also be noted that no established CEM certification method existed in 2007 and still does not today. Some of our kilns today have been equipped with newer technology monitors that are calibrated daily and believed to provide a more representative value than the data we were able to obtain in the period you are interested in, but that is not helpful with respect to the wet process kilns in Midlothian as they were never equipped with this type of monitor.  Furthermore, the data we collected both then and now is a total ammonia concentration value, representing variability of both naturally occurring ammonia in the raw materials and that from ammonia slip due to SNCR use. It is not possible to discern the source of the ammonia and it is clear that there is significant variability in the raw material influence on emissions.  It is difficult to conclude how much ammonia slip came from SNCR when the naturally occurring ammonia emissions fluctuate between 5 and 25 ppm, while the "slip" allowance was an additional 10 ppm above background.

I have provided answers to your questions below, after restating the questions.

      1) The NOx emissions (lb/ton clinker) in 2009-2010 returned to, or were even higher than, the pre-SNCR levels in 2006 and 2007.  Can you explain why this occurred?  (I understand that Kiln 1 operated with SNCR during the 2007 ozone season.)            I think what you are seeing here is the difference in what was required versus what was voluntary. The initial Kiln 1 SNCR installation was in 2007, but the facility was not yet required to operate SNCR for any specified time or achieve a particular NOx emission limit. This work was done in preparation for the 2009 SIP limit, but since SNCR had not yet been tried on a long wet kiln, the period between installation and the SIP limit was used to understand how the system would operate once a lower NOx limit was imposed on the plant.  In 2008 the plant was in the process of evaluating performance parameters and control capabilities for the system.  In 2009 and 2010 the plant operated in line with the requirements of the SIP, operating SNCR only during ozone season and only as necessary to comply with the site-wide SIP limit of 4.41 tons/day.  Bear in mind that during 2009 and 2010, cement demand was sharply lower than in 2007, so our site-wide SIP limit could often be met without the use of SNCR because one or more of the kilns was idle.  After the March 11, 2011 agreement was finalized with the Cities, the plant was required to achieve 3.6 lb/ton clinker on a 30 day rolling average basis for each kiln, so more SNCR use was necessary to comply.                  2) The NH3 emissions (lb/ton clinker) in 2009-2010 were much lower than in 2008?  Can you explain why this occurred?  Is it indication that far less reagent was being used?  Was the amount of reagent constrained by ammonia slip?  Or was the goal to comply with the non-attainment area NOx emission limit, but otherwise to limit reagent injection?            Correct, as explained above, less reagent was used during 2009-2010 because we were able to idle kilns due to low demand and achieve the SIP limit without SNCR.              For periods before the City agreement, the plant only operated the SNCR systems during ozone season and as needed to comply with other requirements that were not as stringent. Also, while the facility had a plant-wide SIP daily total NOx emissions limit, the limit  only applied during ozone season (March 1 through November 31 -  TCEQ state rule 117 defines this period). The SIP allowed 4.41 tons of NOx per day, regardless of production rate or number of kilns operating.  Once the 3.6 lb/ton limit of the City agreement applied, the facility operated in such a way that both limits were complied with at all times.

      3) Can you share the ammonia slip that the Midlothian kilns experienced when the SNCRs were operated (in ppm, all years)?        We had a baseline ammonia rate of 25.1 ppmv and an additional 10 ppmv for ammonia slip.  The Texas rules allowed for this alternative limit. This limit came in to play March 1, 2009 and later.  We cannot tell the difference between slip from SNCR use and raw material related ammonia emissions.  The average ammonia emission was 9.5 ppm with a standard deviation of 5.2 without ammonia injection.  The average value was based on daily average values collected between December 2008 and February 2009.        Note that annual ammonia emissions were quantified on the emissions inventories you provided, so one can see the variation, but keep in mind the value represents total ammonia emissions, not just slip.              4) Can you share NOx and NH3 emissions data for the three kilns after 2010 and prior to their retirement?            Annual emission rates by kiln are included in the attached spreadsheet.  Kilns 1 and 2 operated through September 2014, while Kiln 3 did not operate in 2014 as it was being reconstructed.              5)      Can you share the molar ratio (NH3:NOx) for the three kilns during SNCR operation?        We do not know the molar ratio, only the emission rate and injection rate.              6) Also, I was wondering if you could verify some information that I obtained from Shaun Burke in regard to the Montana City kiln in the nearer term.  We have a reagent (19% aq. NH3) usage rate for Montana City of 0.545 gal/ton clinker as a long-term average.  Is that accurate?               YTD the number is 0.547 gal/ton clinker for 2016.   Thanks in advance.  Please call if you have any questions.


[Federal Register Volume 74, Number 236 (Thursday, December 10, 2009)]
[Notices]
[Pages 65590-65591]
[FR Doc No: E9-29399]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of a Final Environmental Assessment (Final
EA) and a Finding of No Significant Impact (FONSI)/Record of Decision
(ROD) for the Proposed Airport Traffic Control Tower With Associated
Base Building and Airport Surveillance Radar, Model 9, Replacement/
Relocation at Cleveland Hopkins International Airport, Cleveland, OH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Availability of a Final Environmental Assessment (EA)
and Finding of No Significant Impact (FONSI)/Record of Decision (ROD)
for a Proposed Airport Traffic Control Tower with Associated Base
Building and an Airport Surveillance Radar, Model 9, Replacement/
Relocation at Cleveland Hopkins International Airport, Cleveland, Ohio.

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SUMMARY: The Federal Aviation Administration (FAA) is issuing this
notice to advise the public that the FAA has prepared, and approved on
November 18, 2009, a Finding of No Significant Impact (FONSI)/Record of
Decision (ROD) based on the Final Environmental Assessment (Final EA)
for a Proposed Airport Traffic Control Tower (ATCT) with Associated
Base Building and an Airport Surveillance Radar, Model 9 (ASR-9),
Replacement/Relocation at Cleveland Hopkins International Airport,
(CLE) Cleveland, Ohio. The FAA prepared the Final EA in accordance with
the National Environmental Policy Act and the FAA's regulations and
guidelines for environmental documents. The Final EA was reviewed and
evaluated by the FAA, and was accepted on October 22, 2009 as a Federal
document by the FAA's Responsible Federal Official.

FOR FURTHER INFORMATION CONTACT: Ms. Virginia Marcks, Manager,
Infrastructure Engineering Center, AJW-C14D, Federal Aviation
Administration, 2300 East Devon Avenue, Des Plaines, Illinois 60018.
Telephone number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Final EA evaluated the construction and
operation of a new ATCT and replacement and relocation of the ASR-9 at
CLE. The ATCT would be constructed in the southeast portion of CLE on
Taxiway KI and have a maximum height of 325 feet above ground level
(AGL). The facility would include a Base Building/Terminal Radar
Approach Control (TRACON) Facility, employee parking, security fence
and an access road across abandoned Taxiway Q from Postal Road. The
facility components will consist of the ATCT cab, tower shaft, Base
Building, personnel parking, and guardhouse. The new ATCT and Base
Building/TRACON shall be designed to incorporate, as practicable,
energy-efficient design, equipment, systems and other measures in their
construction in order to reduce energy consumption and improve
environmental performance of the new facilities. There will be a
maximum of 150 parking spaces for ATCT controllers, the TRACON staff,
technical operations staff, administrative personnel, visitors, and
Systems Support Center personnel. There will also be a two-story Base
Building/TRACON facility with approximately 45,000SF of space. The
tower will have an 850 SF cab and a cab eye level elevation of 305 feet
AGL. The total space will accommodate the needed staffing and new
communications and surveillance equipment. The ATCI's water, sewer, and
electrical feeds will be extended and connected to the existing utility
lines on the airport. Drainage and runoff will be collected for
conveyance via the airport's stormwater drainage system, which is
reported by CLE to have excess capacity.
    The project also includes replacing and relocating the ASR-9
surveillance radar equipment to a location that is adjacent to the
future expansion area of the CLE's Riveredge employee parking lot.
Relocation of the ASR-9 is needed because the preferred location for
the ATCT lies within the 1,500-foot Clear Area of the airport's
existing ASR-9, and the new ATCT shaft would block the radar antenna's
coverage to the southeast of the airport. The ASR-9 will be relocated
to the Riveredge site to provide unobstructed radar coverage of the
ASR-9's 60-mile service area. The base of the ASR-9 tower will be four
concrete pylons set on a 30-foot by 30-foot grid, with an equipment
shelter, HVAC pads, and security fence. Utility feeds will be from
adjacent services in the employee parking lot, as well as from the
nearby Remote Transmitter/Receiver (RTR) facility. Access will be via a
stub driveway from the existing Riveredge employee parking lot gate.
The new ASR-9 will provide enhanced coverage prior to the old ASR-9
being

shut down. Once the new ASR-9 is up and running, the old ASR-9 will be
decommissioned and construction will begin on the new ATCT.
    The Final EA has been prepared in accordance with the National
Environmental Policy Act (NEPA) of 1969, as amended, and FAA Order
1050.1E, ``Environmental Impacts: Policies and Procedures.'' In
addition, FAA Order 5050.4B, ``National Environmental Policy Act (NEPA)
Implementing Instructions for Airport Actions'' has been used as
guidance the preparation of the environmental analysis.

    Issued in Des Plaines, Illinois, on December 3, 2009.
Virginia Marcks,
Manager, Infrastructure Engineering Center, Chicago, AJW-C14D Federal
Aviation Administration.
[FR Doc. E9-29399 Filed 12-9-09; 8:45 am]
BILLING CODE 4910-13-M


[Federal Register: November 5, 2008 (Volume 73, Number 215)]
[Rules and Regulations]
[Page 65735-65739]
[DOCID:fr05no08-4]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2008-0495; FRL-8737-9]

Withdrawal of the Federal Water Quality Standards Use
Designations for Soda Creek and Portions of Canyon Creek, South Fork
Coeur d'Alene River, and Blackfoot River in Idaho

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; Withdrawal of direct final rule.

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SUMMARY: EPA is promulgating the withdrawal of the Federal water
quality standards designating cold water biota uses for Soda Creek and
portions of Canyon Creek, South Fork Coeur d'Alene River, and Blackfoot
River in Idaho. EPA published a direct final rule with a parallel
proposal for this action on August 19, 2008. EPA is withdrawing the
direct final rule prior to its effective date because EPA received
comments that could be viewed as adverse. The Federal water quality
standards designating cold water biota uses are no longer necessary
since EPA approved Idaho's adopted uses that result in protection for
cold water biota. EPA is also promulgating the withdrawal of the water
quality standards variance provision applicable to these uses, because
this provision is no longer necessary given the withdrawal of the
Federal water quality standards designating these uses.

DATES: Effective November 5, 2008, EPA withdraws the direct final rule
published at 73 FR 48300, on August 19, 2008. The effective date of
this final rule is December 5, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OW-2008-0495. All documents in the docket are listed on the
http://www.regulations.gov Web site. Although listed on the Web site,
some information is not publicly available, e.g., 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 through
http://www.regulations.gov or in hard copy at two docket facilities.
The OW Docket Center is open from 8:30 until 4:30 p.m., Monday through
Friday, excluding legal holidays. The OW Docket Center telephone number
is<PHONE_NUMBER>, and the Docket address is OW Docket, EPA West, Room
3334, and 1301 Constitution Avenue, NW., Washington, DC 20004. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Publicly available docket materials are
also available in hard copy at U.S. EPA, Region 10, and 1200 Sixth
Avenue, Suite 900, Seattle, WA 98101. Docket materials can be accessed
from 9 a.m. until 3 p.m., Monday through Friday, excluding legal
holidays. The telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Danielle Salvaterra, U.S. EPA
Headquarters, Office of Water, Mailcode: 4305T, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>or
Lisa Macchio, U.S. EPA, Region 10, Mailcode: OWW-131, 1200 Sixth
Avenue, Suite 900, Seattle, Washington 98101; telephone number: 206-
553-1834; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA is promulgating the withdrawal of the
Federal water quality standards designating cold water biota uses for
Soda Creek and portions of Canyon Creek, South Fork Coeur d'Alene
River, and Blackfoot River in Idaho. EPA published the proposal for
this final rulemaking on August 19, 2008. EPA is taking further action
to withdraw a direct final rule that EPA published on

August 19, 2008 (73 FR 48300). We stated in that direct final rule that
if we received adverse comment by September 18, 2008, the direct final
rule would not take effect, and we would publish a timely withdrawal in
the Federal Register. EPA received two comments which could be viewed
as adverse comments. Importantly, because the comments when considered
by EPA did not result in a change in EPA's position, the direct final
rule would have resulted in the same action EPA is taking by this final
rule. As stated in the direct final rule and the parallel proposed
rule, we have not instituted a second comment period on this action.
    In July 1997, EPA promulgated a Federal rule designating uses for
water bodies in the State of Idaho, including the designation of cold
water biota for Soda Creek, and portions of Canyon Creek, South Fork
Coeur d'Alene River, and Blackfoot River, with the exception of any
portion in Indian country (62 FR 41183, July 31, 1997). In March 2000,
Idaho adopted a revised use for a segment of Blackfoot River, which
changed from ``Protected for Future Use'' to undesignated. In Idaho,
undesignated waters are protected for all recreational use in and on
the water and for the propagation of fish, shellfish, and wildlife
(IDAPA <IP_ADDRESS>.01). In March 2002, Idaho adopted a use designation
of cold water biota for segments of Canyon Creek and South Fork Coeur
d'Alene River. In March 2006, Idaho adopted a revised use for Soda
Creek, which changed from ``NONE'' to undesignated. As described in the
undesignated surface waters provision of Idaho's Water Quality
Standards (IDAPA <IP_ADDRESS>.01.a), the Idaho Department of
Environmental Quality (IDEQ) applies cold water aquatic life criteria
to undesignated waters because it is presumed that most waters in the
State will support cold water aquatic life. Thus, cold water aquatic
life criteria now apply to Soda Creek and the segment of the Blackfoot
River. EPA approved Idaho's revised water quality standards for
segments of Canyon Creek and South Fork Coeur d'Alene River on June 24,
2005, and for Soda Creek on August 15, 2006. EPA approved Idaho's
revised water quality standards for the segment of the Blackfoot River,
except for any portion in Indian country, on August 22, 2006. Thus, the
Federal water quality standards designating Soda Creek and portions of
Canyon Creek, South Fork Coeur d'Alene River, and Blackfoot River for
cold water biota use (40 CFR 131.33(b)) are no longer necessary, and
EPA is promulgating the withdrawal of these standards with this action.
EPA is also promulgating the withdrawal of the water quality standards
variance provision applicable to these uses (40 CFR 131.33(d)), because
this provision is no longer necessary given the withdrawal of the
Federal water quality standards designating these uses.

I. What Entities May Be Affected by This Action?

    Citizens concerned with water quality in Idaho may be interested in
this rulemaking. Entities discharging pollutants to Soda Creek, Canyon
Creek, South Fork Coeur d'Alene, and Blackfoot River in Idaho could be
indirectly affected by this rulemaking because water quality standards
are used in determining National Pollutant Discharge Elimination System
(NPDES) permit limits. Because this action withdraws the Federal water
quality standards designating cold water biota uses that are no longer
necessary since EPA approved Idaho's adopted uses that result in
protection for cold water biota, the effect of this rulemaking may only
occur when entities seek variances to water quality standards. Entities
seeking variances from use designations on these waters will now apply
to the state, and EPA will act on the state's decision to grant the
variance.
    Categories and entities that may ultimately be affected include:

------------------------------------------------------------------------
                                      Examples of potentially affected
             Category                             entities
------------------------------------------------------------------------
Industry..........................  Industries discharging pollutants to
                                     Soda Creek, Canyon Creek, South
                                     Fork Coeur d'Alene River, and
                                     Blackfoot River in Idaho.
Municipalities....................  Publicly owned treatment works
                                     discharging pollutants to Soda
                                     Creek, Canyon Creek, South Fork
                                     Coeur d'Alene River, and Blackfoot
                                     River in Idaho.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding NPDES regulated entities likely to be
affected by this action. This table lists the types of entities that
EPA is now aware could potentially be affected by this action.

II. Background

    On July 31, 1997, pursuant to section 303(c) of the Clean Water Act
(CWA), EPA promulgated water quality standards for Idaho, which
designated several water body segments for cold water biota use. These
segments included: a segment of the Blackfoot River, then identified as
USB 360--Equalizing Dam to mouth (with the exception of any portion in
Indian country); a segment of Canyon Creek (segment PB 121)--below
mining impact; a segment of South Fork Coeur d'Alene River (segment PB
140S)--Daisy Gulch to mouth; and Soda Creek (segment BB 310)--source to
mouth.
    A. Blackfoot River: In March 2000, the Idaho Legislature adopted
revised water quality standards, providing an undesignated use for the
segment of the Blackfoot River that the Federal rule addressed (IDAPA
<IP_ADDRESS>.09). In Idaho, undesignated waters are protected for all
recreational use in and on the water and for the propagation of fish,
shellfish, and wildlife (IDAPA <IP_ADDRESS>.01). Given the flow
limitations on the Blackfoot River segment, IDEQ removed the aquatic
life use designation of ``Protected for Future Use'' from the Blackfoot
River segment and left the use undesignated so that a more appropriate
aquatic use designation may be described and added to Idaho water
quality standards in the future. As described in the undesignated
surface waters provision (IDAPA <IP_ADDRESS>.01.a), IDEQ applies cold
water aquatic life criteria to undesignated waters because it is
presumed that most waters in the State will support cold water aquatic
life. As EPA stated in its approval letter of August 22, 2006, EPA
considers Idaho's revision to provide a default cold water aquatic life
use designation for the Blackfoot River segment, except for any portion
in Indian country. EPA would consider any change in the level of
protection afforded to the Blackfoot River segment to be a revision to
Idaho's water quality standards, subject to EPA review pursuant to 40
CFR Part 131. The water quality standards revision also included a
reformatting and renumbering of the Water Body/Basin Designation Tables
and the segment of the Blackfoot River previously identified as USB 360
(Equalizing Dam to mouth) was renumbered to US-1 (Fort Hall Main Canal
diversion to mouth), which is within the Blackfoot Subbasin of the
Upper Snake Basin. Thus, cold water aquatic life criteria now apply to
the US-1 segment of the Blackfoot River, which was formerly

identified as USB 360. EPA approved Idaho's revision, except for any
portion in Indian country, on August 22, 2006. The 1997 promulgation
establishing the Federal water quality standards designating uses for
Blackfoot River did not apply to waters in Indian country; likewise,
EPA's approval of the state's designated use for Blackfoot River
excludes waters in Indian country.
    B. Canyon Creek and South Fork Coeur d'Alene River: On March 15,
2002, the Idaho Legislature adopted revised water quality standards,
including the cold water biota designated use for Canyon Creek, which
was previously identified as PB 121 (below mining impact) and is now
renumbered and renamed segment P-14 (from and including Gorge Gulch to
mouth); and South Fork Coeur d'Alene River, which was previously
identified as segment PB 140S and is now renumbered and includes two
segments: Segment P-1 (Canyon Creek to mouth) and segment P-11 (from
and including Daisy Gulch to Canyon Creek) (IDAPA <IP_ADDRESS>.09).
Canyon Creek and the South Fork Coeur d'Alene River are within the
South Fork Coeur d'Alene River Subbasin of the Panhandle Basin. Canyon
Creek in its entirety, including segments P-14 (from and including
Gorge Gulch to mouth) and P-15 (source to Gorge Gulch), is designated
for cold water biota. The South Fork Coeur d'Alene River is also
designated for cold water biota use in its entirety; the South Fork
Coeur d'Alene River upstream of Daisy Gulch (segment P-13--source to
Daisy Gulch) was already designated as a cold water biota use. When the
State first established its water quality standards, it included the
phrase ``below mining impact'' to identify a number of stream segments
in order to account for the lingering adverse environmental effects of
numerous abandoned mines in the State. EPA recognized the concerns of
the State and used the same terminology in its promulgation of Federal
standards on July 31, 1997. EPA approved Idaho's revisions on June 24,
2005.
    C. Soda Creek: In March 2006, the Idaho Legislature adopted revised
water quality standards, removing the use designation of ``NONE'' and
providing an undesignated use for Soda Creek. In Idaho, undesignated
waters are protected for all recreational use in and on the water and
for the propagation of fish, shellfish, and wildlife (IDAPA
<IP_ADDRESS>.01). Soda Creek had been identified as segment BB 310
(source to mouth) and is now renumbered and includes three segments:
segments B-23 (Soda Creek Reservoir Dam to Alexander Reservoir), B-24
(Soda Creek Reservoir), and B-25 (source to Soda Creek Reservoir) in
the South Fork Clearwater Subbasin of the Clearwater Basin (IDAPA
<IP_ADDRESS>.02). IDEQ initially proposed that Soda Creek be designated
for coldwater aquatic life use. However, due to a lack of data,
particularly water temperature records, showing that cold water aquatic
life criteria were met, Soda Creek was left undesignated. As described
in the undesignated surface waters provision (IDAPA <IP_ADDRESS>.01.a),
IDEQ applies cold water aquatic life criteria to undesignated waters
because it is presumed that most waters in the State will support cold
water aquatic life. Thus, cold water aquatic life criteria now apply to
Soda Creek. EPA approved Idaho's revision on August 15, 2006. As EPA
stated in this approval letter, EPA considers Idaho's revision to
provide a default cold water aquatic life use designation for Soda
Creek. EPA would consider any change in the level of protection
afforded to Soda Creek to be a revision to Idaho's water quality
standards, subject to EPA review pursuant to 40 CFR Part 131.
    D. EPA-approved Use Designations and Criteria: For Blackfoot River
(US-1) and Soda Creek (B-23, B-24, and B-25), the State now applies an
undesignated use that is practically equivalent to the aquatic life use
established by EPA in its July 31, 1997, rulemaking because cold water
biota criteria apply. Specifically, Idaho's undesignated surface waters
provision states (IDAPA <IP_ADDRESS>):

    ``Surface waters not designated in Sections 110 through 160
shall be designated according to Section 39-3604, Idaho Code, taking
into consideration the use of the surface water and such physical,
geological, chemical, and biological measures as may affect the
surface water. Prior to designation, undesignated waters shall be
protected for beneficial uses, which includes all recreational use
in and on the water and the protection and propagation of fish,
shellfish, and wildlife, wherever attainable.
    a. Because [IDEQ] presumes most waters in the state will support
cold water aquatic life and primary or secondary contact recreation
beneficial uses, [IDEQ] will apply cold water aquatic life and
primary or secondary contact recreation criteria to undesignated
waters unless Sections 101.01.b and 101.01.c. are followed.
    b. During the review of any new or existing activity on an
undesignated water, [IDEQ] may examine all relevant data or may
require the gathering of relevant data on beneficial uses; pending
determination in Section 101.01.c. existing activities will be
allowed to continue.
    c. If, after review and public notice of relevant data, it is
determined that beneficial uses in addition to or other than cold
water aquatic life and primary or secondary contact recreation are
appropriate, then [IDEQ] will:
    i. Complete the review and compliance determination of the
activity in context with the new information on beneficial uses, and
    ii. Initiate rulemaking necessary to designate the undesignated
water, including providing all necessary data and information to
support the proposed designation.''

For Canyon Creek (P-14) and South Fork Coeur d'Alene River (P-1 and P-
11), the State now applies an aquatic life use designation that is the
same as the one established by EPA in its July 31, 1997 rulemaking
(``cold water biota''). Therefore, withdrawing the Federal water
quality standards designating these uses will not result in a change in
the level of protection afforded to Soda Creek, Canyon Creek, South
Fork Coeur d'Alene River, or Blackfoot River.

III. Withdrawal of Federal Water Quality Standards

A. Proposal

    On August 19, 2008 (73 FR 48351), EPA proposed to withdraw the
Federal water quality standards designating Soda Creek and portions of
Canyon Creek, South Fork Coeur d'Alene River, and Blackfoot River for
cold water biota use, on the grounds that these Federal standards are
no longer necessary, in light of Idaho's subsequent revisions to its
state water quality standards.

B. Comments

    One commenter was concerned that the proposed withdrawal of Federal
water quality standards would reduce water quality monitoring
requirements for Soda Creek and the pertinent portions of Canyon Creek,
South Fork Coeur d'Alene River, and Blackfoot River. However, EPA's
withdrawal of Federal water quality standards neither removes nor
imposes any requirements regarding water quality monitoring for these
waters. EPA's final rule only removes the Federal use designation for
the waters. State water quality standards identical or equivalent to
those being withdrawn have been adopted by Idaho and have been approved
by EPA. Therefore, the Federal water quality standards are no longer
necessary.
    Another commenter believed it should be made clear that site-
specific aquatic life criteria for lead, zinc, and cadmium, which can
be found at IDAPA <IP_ADDRESS>4, apply to Canyon Creek and South Fork
Coeur d'Alene River. EPA agrees, and has revised the preamble to this
rule accordingly. The commenter also noted an additional typographical
error, which EPA has corrected in the final rule.

C. Final Rule

    EPA is promulgating, as proposed, the rule to withdraw the Federal
water

quality standards that designated uses for Soda Creek and portions of
Canyon Creek, South Fork Coeur d'Alene River, and Blackfoot River. For
the reasons set forth in Section II, EPA's action does not change the
water quality criteria that apply to these water bodies. Idaho's water
quality criteria that provide protection for the cold water aquatic
life use are found in several sections of Idaho's water quality
standards. Specifically, the general surface water criteria applicable
to all surface waters in Idaho are provided in IDAPA <IP_ADDRESS>, and
numeric criteria for toxic substances for waters designated for aquatic
life use apply per IDAPA <IP_ADDRESS>.01.a. IDAPA <IP_ADDRESS> provides
additional aquatic life criteria applicable to the segments from which
the Federal water quality standards are being withdrawn, including
general criteria for pH and dissolved gas that apply to all aquatic
life use designations (IDAPA <IP_ADDRESS>.01), as well as cold water
criteria for dissolved oxygen, temperature, ammonia (acute and
chronic), and turbidity that apply to waters designated for cold water
aquatic life (IDAPA <IP_ADDRESS>.02). IDAPA <IP_ADDRESS>4 provides site-
specific aquatic life criteria for lead, zinc, and cadmium that apply
in Canyon Creek and South Fork Coeur d'Alene River.

IV. Withdrawal of Water Quality Standards Variance Provision

    When, in July 31, 1997, EPA originally promulgated Federal water
quality standards designating uses for Idaho waters (62 FR 41162), EPA
also included a water quality standards variance provision (40 CFR
131.33(d)) authorizing the EPA Region 10 Regional Administrator to
grant variances from the Federal water quality standards that
designated the cold water biota uses. Because this final rule removes
the Federal water quality standards designating these uses, provision
40 CFR 131.33(d) is no longer necessary and is also being withdrawn.
EPA received no comments on the portion of the proposed rule
withdrawing the water quality standards variance provision. EPA is
therefore promulgating, as proposed, this portion of the rule. Idaho
has adopted its own water quality standards variance provision (IDAPA
<IP_ADDRESS>0), which was approved by EPA on June 25, 1996.

V. Statutory and Executive Order Reviews

A. Executive Order 12866 (Regulatory Planning and Review)

    This rule withdraws Federal requirements applicable to Idaho and
imposes no regulatory requirements on any person or entity, does not
interfere with the action or planned action of another agency, and does
not have any budgetary impacts or raise novel legal or policy issues.
The rule imposes no additional cost on the regulated community because
it will not change the level of environmental protection already
achieved. The rule imposes only minimal additional effort on the State
of Idaho as the regulator, because entities seeking variances from use
designations will now apply to the state instead of to EPA. Thus, it
has been determined that this rule is not a ``significant regulatory
action'' under the terms of Executive Order 12866 (58 FR 51735, October
4, 1993) and is therefore not subject to review under the Executive
Order (EO).

B. Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.), because it is administratively withdrawing Federal
requirements that no longer need to apply to Idaho.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), as
amended by the Small Business Regulatory Enforcement Fairness Act of
1996, generally requires an agency to prepare a regulatory flexibility
analysis of a rule that is subject to notice and comment rulemaking
requirements under the Administrative Procedure Act or any other
statute unless the agency certifies that the rule will not have
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    This rule imposes no regulatory requirements or costs on any small
entity. Therefore, I certify that this rule will not have a significant
economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act (UMRA), Public Law
104-4 establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, Tribal, and local
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    This rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, Tribal, or local
governments or the private sector because it imposes no enforceable
duty on any of these entities. Thus, this rule is not subject to the
requirements of UMRA sections 202 and 205. Similarly, EPA has
determined that this rule contains no regulatory requirements that
might significantly or uniquely affect small governments and is
therefore not subject to UMRA section 203.

E. Executive Order 13132 (Federalism)

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an

accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects 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.''
    This rule does not have federalism implications. It will not have
substantial direct effects 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, as
specified in Executive Order 13132. This rule imposes no regulatory
requirements on any State, Tribal, or local government. The rule
imposes only minimal additional effort on the State of Idaho as the
regulator, because entities seeking variances from use designations
will now apply to the state instead of to EPA. Thus, Executive Order
13132 does not apply to this rule.

F. Executive Order 13175 (Consultation and Coordination With Indian
Tribal Governments)

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This rule does not have
tribal implications, as specified in Executive Order 13175. It imposes
no regulatory requirements or costs on any Tribal government. It does
not have substantial direct effects on Tribal governments, 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. Thus, Executive Order 13175 does not
apply to this rule.

G. Executive Order 13045 (Protection of Children From Environmental
Health and Safety Risks)

    This rule is not subject to EO 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant as
defined in EO 12866, and EPA has no reason to believe the environmental
health or safety risks addressed by this rule present a
disproportionate risk to children.

H. Executive Order 13211 (Actions That Significantly Affect Energy
Supply, Distribution, or Use)

    This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001), because it is not a
significant regulatory action under EO 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law No. 104-113, 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. NTTAA directs EPA to
provide Congress, through OMB, explanations when the Agency decides not
to use available and applicable voluntary consensus standards.
    This rule does not involve technical standards. Therefore, EPA did
not consider the use of any voluntary consensus standards.

J. Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations)

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this rule will not have disproportionately
high and adverse human health or environmental effects on minority or
low-income populations, because it does not affect the level of
protection provided to human health or the environment.

K. Congressional Review Act

    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 rule 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 rule is not a ``major rule'' as defined by 5 U.S.C.
804(2) and will be effective on December 5, 2008.

List of Subjects in 40 CFR Part 131

    Environmental protection, Intergovernmental relations, Reporting
and recordkeeping requirements, Water pollution control, Water quality
standards.

    Dated: October 30, 2008.
Stephen L. Johnson,
Administrator.

0
Accordingly, the amendments to the rule published on August 19, 2008
(73 FR 48300) are withdrawn as of November 5, 2008.
0
In addition, for the reasons set forth in the preamble, 40 CFR part 131
is amended as follows:

PART 131--WATER QUALITY STANDARDS

0
1. The authority citation for part 131 continues to read as follows:

    Authority: 33 U.S.C. 1251 et seq.

Sec.  131.33   [Amended]

0
2. Section 131.33 is amended by removing and reserving paragraph (b)
and by removing paragraph (d).

[FR Doc. E8-26402 Filed 11-4-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 25 (Wednesday, February 8, 2017)]
[Notices]
[Pages 9803-9804]
[FR Doc No: 2017-02536]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79931; File No. SR-CFE-2017-001]

Self-Regulatory Organizations; CBOE Futures Exchange, LLC; Notice
of Filing of a Proposed Rule Change Regarding Block Trades

February 2, 2017.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on January 19, 2017 CBOE
Futures Exchange, LLC (``CFE'' or ``Exchange'') filed with the
Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change described in Items I, II, and III below, which
Items have been prepared by CFE. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons. CFE also has filed this proposed rule change with the
Commodity Futures Trading Commission (``CFTC''). CFE filed a written
certification with the CFTC under Section 5c(c) of the Commodity
Exchange Act (``CEA'') \2\ on January 19, 2017.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(7).
    \2\ 7 U.S.C. 7a-2(c).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Description of the Proposed Rule
Change

    The Exchange proposes to amend CFE Rule 415 related to Block
Trades. The scope of this filing is limited solely to the application
of the proposed rule amendments to security futures that may be traded
on CFE. Although no security futures are currently listed for trading
on CFE, CFE may list security futures for trading in the future. The
text of the proposed rule change is attached as Exhibit 4 to the filing
but is not attached to the publication of this notice.

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

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

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

1. Purpose
    CFE Rule 415 sets forth requirements relating to Block Trades. The
proposed rule change adds paragraph (l) to Rule 415 which relates to
the front running of Block Trades. Proposed Rule 415(l) makes clear
that no person may engage in the front running of a Block Trade when
acting on material non-public information regarding an impending
transaction by another person, acting on non-public information
obtained through a confidential employee/employer relationship, broker/
customer relationship, or in breach of a pre-existing duty. Proposed
Rule 415(l) would apply to all products traded on CFE, including both
non-security futures and security futures.
    The proposed rule change is being made in connection with other
proposed amendments to Rule 415 which are not included as part of this
proposed rule change. Those proposed amendments are to be included in
new paragraph (k) of Rule 415.\3\ The provisions of proposed Rule
415(k) are intended to clarify certain restrictions relating to
disclosure and use of non-public information regarding Block Trades and
the extent to which counterparties to a Block Trade may enter into pre-
hedging or anticipatory hedging transactions in connection with Block
Trades. Proposed Rule 415(k) would only apply to non-security futures,
and the Exchange is including a sentence in proposed Rule 415(k) to

make clear that its provisions do not apply to security futures.
---------------------------------------------------------------------------

    \3\ Paragraph (k) will be filed simultaneously with paragraph
(l) with CFTC which is why the provisions of paragraph (l) are
marked as existing rule text in Exhibit 4.
---------------------------------------------------------------------------

    The Exchange is also re-lettering certain paragraphs in Rule 415 to
accommodate for the new provisions that are being added.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\4\ in general, and furthers the
objectives of Sections 6(b)(5) \5\ and 6(b)(7) \6\ in particular in
that it is designed:
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
    \6\ 15 U.S.C. 78f(b)(7).
---------------------------------------------------------------------------

     To prevent fraudulent and manipulative acts and practices,
     to promote just and equitable principles of trade, and
     to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and in general, to
protect investors and the public interest.
    The Exchange believes that the proposed rule change would provide
additional guidance to CFE market participants related to the front
running of Block Trades. The proposed rule change would also contribute
to enhanced protection of CFE's market and market participants.

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

    CFE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act, in that the proposed rule change is consistent
with similar guidance provided by other designated contracts
markets.\7\ The Exchange believes that the proposed rule change is
equitable and not unfairly discriminatory in that the rule amendments
included in the proposed rule change would apply equally to all market
participants.
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    \7\ These designated contract markets are Chicago Mercantile
Exchange, Inc. (``CME''), The Board of Trade of the City of Chicago,
Inc., New York Mercantile Exchange, Inc., New York Mercantile
Exchange, Inc., and Commodity Exchange, Inc. See, CME Submission No.
16-470 (November 15, 2016), which is available on the CFTC's Web
site.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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

    The proposed rule change will become operative on February 2, 2017.
At any time within 60 days of the date of effectiveness of the proposed
rule change, the Commission, after consultation with the CFTC, may
summarily abrogate the proposed rule change and require that the
proposed rule change be refiled in accordance with the provisions of
Section 19(b)(1) of the Act.\8\
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    \8\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CFE-2017-001 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CFE-2017-001. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CFE-2017-001, and should be
submitted on or before March 1, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(73).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2017-02536 Filed 2-7-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14779-14780]
[FR Doc No: 2012-6007]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2011-0443; FRL 9513-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Public Water System Supervision
Program (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before April 12,
2012.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2011-0443, to (1) EPA online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code: 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB by mail to:
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Matthew Reed, Drinking Water
Protection Division, Office of Ground Water and Drinking Water,
(4606M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On July 5, 2011 (76 FR 39092), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments during the
comment period. Any comments on this ICR should be submitted to EPA and
OMB within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2011-0443, which is available for online viewing at
www.regulations.gov, or in person

viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA/DC
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Water Docket is
202-566-2426.
    Use EPA's electronic docket and comment system at
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at www.regulations.gov as EPA receives
them and without change, unless the comment contains copyrighted
material, confidential business information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to www.regulations.gov.
    Title: Public Water System Supervision Program (Renewal)
    ICR numbers: EPA ICR No. 0270.45, OMB Control No. 2040-0090
    ICR Status: This ICR is scheduled to expire on March 31, 2012.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the Code of Federal Regulations, after appearing in the
Federal Register when approved, are listed in 40 CFR part 9, are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The Public Water System Supervision (PWSS) Program
Renewal ICR examines public water system, primacy agency, EPA, and
tribal operator certification provider burden and costs for ``cross-
cutting'' recordkeeping and reporting requirements (i.e., the burden
and costs for complying with drinking water information requirements
that are not associated with contaminant-specific rulemakings). These
activities which have record keeping and reporting requirements that
are mandatory for compliance with 40 CFR parts 141 and 142 include the
following: Consumer Confidence Reports (CCRs), Primacy Regulation
Activities, Variance and Exemption Rule (V/E Rule), General State
Primacy Activities, Public Notification (PN) and Proficiency Testing
(PT) Studies for Drinking Water Laboratories. The information
collection activities for both the Operator Certification/Expense
Reimbursement Grant Program and the Capacity Development Program are
driven by the grant withholding and reporting provisions under Sec.
1419 and Sec.  1420, respectively, of the Safe Drinking Water Act.
Although the Tribal Operator Certification Program is voluntary, the
information collection is driven by grant eligibility requirements
outlined in the Drinking Water Infrastructure Grant Tribal Set-Aside
Program Final Guidelines and the Tribal Drinking Water Operator
Certification Program Guidelines.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 4.06
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Owners/operators of public water
systems who must report to the primacy agency. Primacy agencies, which
include States, Tribes (if they have been authorized to act as primacy
agencies), and EPA Regions that act as primacy agencies in Indian
country and States that do not have primacy. Laboratories conducting PT
to achieve state certification, which permits them to analyze samples
for compliance with National Primary Drinking Water Regulations
(NPDWRs). (PT vendors are not considered respondents because they are
paid for their incurred burden and costs via the prices that
laboratories pay for the PT standards.)
    Estimated Number of Respondents: 154,938.
    Frequency of Response: Varies by requirement (i.e., on occasion,
monthly, quarterly, semi-annually, annually, biennially, and every 3,
6, and 9 years).
    Estimated Total Annual Hour Burden: 4,113,408.
    Estimated Total Annual Cost: $187,647,000, which includes
$40,019,000 in capital and operating & maintenance (O&M) costs.
    Changes in the Estimates: There is an increase of 199,864 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This increase is due primarily to consultations
with respondents which yielded more accurate estimates of the burden
for various activities. These were partially offset by burden decreases
from a smaller respondent universe and reduced reporting due to a new
enforcement tracking system and the discontinuation of a grant program.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-6007 Filed 3-12-12; 8:45 am]
BILLING CODE 6560-50-P


Substantive Differences between Notice of Proposed Rulemaking Submitted to OIRA on February 24, 2016 and Published in the FR on July 29, 2016

In accordance with Executive Order (EO) 12866 agencies must:

      (E) After the regulatory action has been published in the Federal Register
      or otherwise issued to the public, the agency shall:

      (i) Make available to the public the information set forth in subsections
      (a)(3)(B) and (C);

      (ii) Identify for the public, in a complete, clear, and simple manner,
      the substantive changes between the draft submitted to OIRA for
      review and the action subsequently announced; and

      (iii) Identify for the public those changes in the regulatory action
      that were made at the suggestion or recommendation of OIRA.

As required by EO 12866, PHMSA is making available the original notice of proposed rulemaking (NPRM) entitled "Hazardous Materials:  Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains" submitted to OIRA on February 24, 2016.  This draft identifies discussions which were revised for clarity. In addition, PHMSA has summarized the substantive changes made at the suggestion of OIRA, as follows:

Substantive Changes to the NPRM Provisions

   1. Effective Date - In the original NPRM submitted to OIRA no effective date was proposed. In the NPRM that published in the Federal Register the effective date was proposed as 60 days after publication of a final rule in the Federal Register. A question was added to solicit comments from interested persons regarding the feasibility of the proposed compliance date
   2. High Volume Areas - The NPRM that published in the Federal Register added questions for commenters about whether response zones should delineate "High Volume Areas," and how such areas should be defined.
   3. Applicability-  The NPRM that published in the Federal Register added a question asking how many rail carriers or trains would be permitted to transport petroleum oil without a comprehensive plan if the applicability of this rulemaking were to incorporate the Association of American Railroads and  American Short Line and Regional Railroad Association  comment  proposing a definition for Petroleum Crude Oil Routes or the quantity of 1,000,000 gallons, and invite public commenters to provide information to assist in further evaluating the benefits and costs of these alternative applicability thresholds.
   4. Training  -  The NPRM that published in the Federal Register added a question about Incident Command System (ICS) training.
   5. Regulatory Flexibility Act - The NPRM that published in the Federal Register added questions about how flexibility could be provided to small entities.

Substantive Changes to the Regulatory Impact Analysis (RIA) for the NPRM

   1. Baseline Analysis  -  Additional discussion and analysis were added to the RIA with regard to the current baseline coverage of Oil Spill Response Organizations (OSROs) and current practices of the rail industry.  PHMSA provided additional narrative on the current operating environment for the rail industry with regard to oil spill planning including location and amount of spill response resources available.  This included mapping the existing OSRO network based on a publicly available U.S. Coast Guard OSRO registry and the current rail network.  PHMSA also clarified the role of the National Contingency Plan (NCP) and Area Contingency Plans (ACPs).
   2. Additional Questions - The RIA that published created a stand-alone section that consolidated all requests for specific comment.  In addition, questions were added to address topics such the size and location of spill response zones, the potential for tiered response zones (6 hour vs. 12 hour), the number of affected entities, the effectiveness of oil spill response plans (OSRPs), and costs affecting the regulated community.
   3. Updated Crude by Rail Movements and Incident Data - The RIA that published has updated Energy Information Agency data on rail movements and additional PHMSA Hazardous Material Incident Report data (2015) that was finalized and made available during the review period.  This resulted in minor updates to the forecasting of future incidents.


[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13392-13393]
[FR Doc No: 2015-05675]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Ear, Nose, and Throat Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Ear, Nose, and Throat Devices Panel of the
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 30 and May 1, 2015
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is<PHONE_NUMBER>.
    Contact Person: Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1535, Silver Spring MD 20993-0002,
<EMAIL_ADDRESS>301-796-6875, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On April 30, 2015, the committee will discuss and make
recommendations regarding the classification of Hearing Protectors,
Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile
Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices
are considered preamendments devices since they were in commercial
distribution prior to May 28, 1976, when the Medical Devices Amendments
became effective. Hearing Protectors are currently regulated under the
heading, ``Protector, Hearing (Insert),'' Product Code EWD, as
unclassified under the 510(k) premarket notification authority.
Circumaural Hearing Protectors are currently regulated under the
heading, ``Protector, Hearing (Circumaural),'' Product Code EWE, as
unclassified under the 510(k) premarket notification authority. Middle
Ear Inflation Devices are currently regulated under the heading,
``Device, Inflation, Middle Ear,'' Product Code MJV, as unclassified
under the 510(k) premarket notification authority. Tactile Hearing Aid
Devices are currently regulated under the heading, ``Hearing Aid,
Tactile,'' Product Code LRA, as unclassified under the 510(k) premarket
notification authority. Vestibular Analysis Apparatuses are currently
regulated under the heading, ``Apparatus, Vestibular Analysis,''
Product Code LXV, as unclassified under the 510(k) premarket
notification authority. FDA is seeking committee input on the risks,
safety and effectiveness and the regulatory classification of Hearing
Protectors, Circumaural Hearing Protectors, Middle Ear Inflation
Devices, Tactile Hearing Aid Devices, and Vestibular Analysis
Apparatuses.
    On May 1, 2015 the committee will discuss key issues related to a
potential pre- to post-market shift in clinical data requirements for
modifications to cochlear implants in pediatric patients. These issues
are categorized into three broad areas for discussion:
    1. Cochlear implant changes (e.g. sound processing features,
patient characteristics) that may be suitable for this pre- to post-
market shift in clinical data requirements.
    2. Appropriate premarket clinical data requirements to support pre-
to post-market shift (e.g. leveraging clinical data from adults and/or
older children).
    3. Clinical study design considerations (e.g. study endpoints and
test metrics, subject characteristics) for post market studies to
confirm safety and effectiveness and inform future labeling.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 22, 2015. Oral presentations from the public will be scheduled
between approximately 8:45 a.m. and 9:45 a.m. on April 30, 2015 and
between approximately 1 p.m. and 2 p.m. on May 1, 2015. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
April 14, 2015. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by April 16, 2015.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact at James Clark at
<EMAIL_ADDRESS>or<PHONE_NUMBER> at least 7 days in advance of
the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05675 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P