1 Proposal for CAIR FIP & Section 126 Response Briefing for OMB 7 12 05 ° This presentation includes:

  General overview of Section 126 and FIP proposals   Explanation of proposed Federal CAIR trading programs   Discussion of proposed minor changes to CAIR & to Acid Rain Program regulations 2 Overview of FIP and Section 126 Proposal ° Combined Proposal   Response to North Carolina Section 126 petition   Federal Implementation Plans ( FIPs) for CAIR   Minor revisions to CAIR   Minor revisions to Acid Rain Program 3 Overview of FIP and Section 126 Proposal ° Rulemaking Schedule   Schedule established in consent decree related to the section 126 petition   Proposal signature by August 1, 2005   Public hearings week of September 12, 2005 in North Carolina and DC area   Final rule signature by March 15, 2006 4 Overview of FIP and Section 126 Proposal ° Summary of Section 126 Petition   Requests that EPA require EGUs in 13 States to reduce emissions of NOx and/ or SO2 that are significantly contributing to PM2.5 and/ or 8 hour ozone nonattainment and maintenance problems in North Carolina ° PM2.5: 12 States: AL, GA, IL, IN, KY, MI, OH,

PA, SC, TN, VA, WV ° 8 hour ozone: 5 States: GA, MD, SC, TN, VA   Based primarily on technical analyses for proposed CAIR 5 Overview of FIP and Section 126 Proposal ° Section 126 Approach   EPA's proposed response to NC section 126 petition is based on upwind State to downwind State linkages established in final CAIR and taking into consideration FIP proposal   For EGUs in States that are linked to North Carolina under the CAIR, EPA is proposing 2 alternative options:

° ( 1) to deny the petition if EPA promulgates FIPs to address the interstate transport no later than the final section 126 response, or ° ( 2) to grant the petition if EPA does not promulgate the FIPs prior to or concurrently with the section 126 response.

  EPA's preferred option is to promulgate the FIP and deny the petition. FIP would provide the relief requested in the petition. 6 Overview of FIP and Section 126 Proposal ° Section 126 Proposal   PM2.5 portion ( EGUs in 12 States):

° Proposing to deny for MI & IL since not linked to NC in final CAIR ° For sources in 10 States linked to NC in final CAIR, proposing in alternative:

  ( 1) to deny petition based on promulgation of FIP prior to or concurrently with the section 126 response, or   ( 2) to grant the petition.

  8 hour ozone portion ( EGUs in 5 States):

° proposing to deny because no States linked to NC 7 Overview of FIP and Section 126 Proposal ° FIP Requirement   Findings of Failure to Submit   On 3/ 10/ 05, EPA issued national findings that States failed to submit SIPs to address interstate transport that were due in July 2000   Findings triggered 2 year clock for EPA to promulgate FIPs to address the interstate transport   CAIR FIP would address EPA responsibility to issue FIPs for CAIR affected States 8 Overview of FIP and Section 126 Proposal ° FIP Approach   Covers whole CAIR region ( 28 States + DC)

  Also covers DE and NJ for PM2.5 based on outstanding proposal to include these States in CAIR for PM2.5   Requires reductions from EGUs   Same budgets and timelines as CAIR 9 Overview of FIP and Section 126 Proposal ° Control Strategy for FIP and Section 126 Response   Proposes Federal NOx and SO2 cap and trade programs for EGUs as the control remedy for both the FIP and section 126 response 10 Overview of FIP and Section 126 Proposal ° Withdrawal of FIP or Section 126 Requirements   Gives States opportunity to submit SIPs, and EPA to approve the SIPs, before we would begin implementing FIP or section 126 requirements   NPR states our intention to withdraw FIP or section 126 requirements in a State in coordination with approval of SIP meeting CAIR requirements   Timing of withdrawal to be addressed on case

bycase basis taking into consideration whether we have already allocated allowances under FIP or section 126 response 11 Overview of FIP and Section 126 Proposal ° FIP As Compliance Option   Also discusses option for States of keeping FIP in place rather than developing SIP as means to save State resources   Provides abbreviated SIP mechanism for States to control certain aspects such as allocations   ( friendly FIP) 12 Proposal for Federal CAIR Trading Programs ° General Approach   CAIR FIP ( and response to NC section 126 petition)

would rely on Federal trading programs that are largely identical to the CAIR SIP model rules ° Annual SO2 program ° Annual NOx program ° Ozone season NOx program   Trading programs for the CAIR FIP, response to NC section 126 petition, and CAIR SIPs would be integrated: Sources located in States governed by any of these programs could trade with each other   Federal trading programs would include relatively minor differences from CAIR SIP rules ( see slides 13

 16)

  Federal programs are designed to provide States with flexibilities similar to those available under CAIR 13 Proposal for Federal CAIR Trading Programs ° Differences from CAIR SIP model rules   Non EGU opt ins ° CAIR SIP rules give States option to include opt in provisions ° Federal CAIR programs would retain flexibility for States to choose whether or not to include opt ins:

  Federal CAIR would not directly include opt ins: Instead, would allow States to choose to submit abbreviated SIP revisions that would provide for units to opt in to the Federal programs ( see slide 14)

  By not including opt ins directly in the Federal CAIR programs  but allowing States to bring opt ins into those programs  we provide the maximum flexibility for States » If Federal CAIR programs included opt ins directly then some units might opt in » Then if EPA subsequently approved a SIP that didn't include opt ins, units that had already opted in would be stranded or else the State would be compelled to implement an opt in program against its preference 14 Proposal for Federal CAIR Trading Programs ° Differences from CAIR SIP model rules ( cont'd)

  Abbreviated SIP revisions ° States that want to participate in the EPA administered CAIR trading programs could choose to submit narrow SIP revisions covering specific critical elements of the Federal CAIR trading programs   to meet their CAIR obligations without the need to submit full SIP revisions ° This provides each State an option by which it can retain control over trading program elements that are most important to it while letting the EPA implement remaining elements (" friendly FIP"

concept) or while awaiting EPA approval of a State's full SIP trading programs ° Abbreviated SIP revisions could include any of the following:

  Non EGU opt in provisions   Allocating NOx allowances ( annual and/ or ozone season) to units   Distributing compliance supplement pool allowances to units   Bringing NOx SIP Call budget trading sources that are not subject to CAIR into the CAIR ozone season trading program 15 Proposal for Federal CAIR Trading Programs ° Differences from CAIR SIP model rules ( cont'd)

  Method for determining credit for early reductions ° CAIR SIP rules provide that States distribute allowances from the annual NOx compliance supplement pool ( CSP) to sources for early NOx reductions in 2007 2008 as well as for need ° For the Federal CAIR we would distribute CSP allowances for early reductions and for need ( same as SIP rules) but would use a more specific criteria for determining early reductions than the criteria specified in the SIP rules   For the Federal CAIR trading program, units would need to operate below a specified NOx emission rate in order to be awarded credit for early reduction ( SIP rules do not specify a maximum NOx rate)

  This method is similar to the approach taken in the NOx SIP Call FIP and section 126 actions 16 Proposal for Federal CAIR Trading Programs ° Differences from CAIR SIP model rules ( cont'd)

  Timing for recording NOx allocations in source accounts ° Federal NOx allocations would be recorded in source accounts on a different schedule than the schedule for recording State allocations in the CAIR SIP model allocation methodology ° The schedule in the Federal CAIR programs is intended to balance the need to provide sources their allocations in sufficient time to plan compliance with the need to provide time for States to submit and EPA to approve SIP revisions ° Proposed schedule for recording Federal NOx allocations:

  record in Dec 2007 for 2009 ( 1 year in advance)

  record in Dec 2008 for 2010 ( 1 year in advance)

  record in Dec 2009 for 2011 ( 1 year in advance)

  record in Dec 2009 for 2012 ( 2 years in advance)

  record in Dec 2009 for 2013 ( 3 years in advance)

  record in Dec 2010 for 2014 ( 3 years in advance)

° In comparison, the schedule in CAIR SIP model methodology is:

  record in Dec 2006 for 2009 through 2014 *

  record in Dec 2009 for 2015 ( 5 years in advance)

  record in Dec 2010 for 2016 ( 5 years in advance)

* We'd propose changing the date for initial allocations in the CAIR SIP model methodology, as discussed later in this presentation 17 Proposed Changes to CAIR Regulations ° The package includes proposed revisions to the CAIR regulations to facilitate interaction between Federal CAIR trading programs and State CAIR trading programs, to correct minor errors, and to provide clarification ° The proposed Federal CAIR programs are designed to match the CAIR regulations including these proposed changes 18 Proposed Changes to CAIR Rules ( cont'd)

  Applicability: Revisions to clarify the definition of EGU under CAIR ° Propose to establish exemption for certain solid waste incinerators ( analogous to exemption for such units under the Acid Rain Program)

° Propose to exempt units that have not served a generator producing electricity for sale since before November 15, 1990 ( analogous to the approach under the Acid Rain Program)

° The EGU definition in the proposed Federal CAIR trading programs includes these same exemptions   Penalty provisions for excess SO2 emissions ° Propose to revise penalty provisions for units that have excess emissions under both the ARP and CAIR SO2 trading programs   so that a given ton of excess emissions would not trigger application of the automatic penalties under both the Acid Rain and CAIR trading programs 19 Proposed Changes to CAIR Rules ( cont'd)

  Minor corrections of the CAIR model trading rules ° For example:

  Propose to remove provisions in the CAIR SO2 model trading rule that reference non existent provisions about SO2 allowance allocations   Propose to remove the deadline ( Dec 2006) for recordation of allocations for the first set of years submitted in SIP revisions because that date would provide inadequate time for EPA to approve revisions ( which are due Sept 2006)   we would retain recordation deadlines for allocations for subsequent years   Abbreviated SIP revisions ° We would add provisions in the Part 51 CAIR regulations to accommodate abbreviated SIP revisions 20 Proposed Changes to Acid Rain Program Rules ° The package includes proposed minor changes to the ARP regulations to provide clarity and streamline requirements,

including:

  Changes to administrative appeals procedures to cover CAIR Federal trading programs ( analogous to procedures covering CAIR SIP trading programs)

  Changes in language regarding some certifications, making the language the same as that in the State and Federal CAIR trading programs ( in order to streamline the requirements for units affected by both CAIR and ARP)

  Revisions to reflect the change  finalized in the CAIR rulemaking

from unit level to source level compliance with the ARP trading program ( e. g., to remove a provision that allows two designated representatives for the same source under certain circumstances   this is no longer workable since one individual must be responsible for compliance by all units at the source)


[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Rules and Regulations]
[Pages 23599-23601]
[FR Doc No: 2012-9518]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2011-1176]
RIN 1625-AA08

Special Local Regulations for Marine Events; Potomac River,
Charles County, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary Final rule.

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

SUMMARY: The Coast Guard is establishing special local regulations
during the ``Potomac River Sharkfest Swim'' amateur swim, a marine
event to be held on the waters of the Potomac River on June 2, 2012.
These special local regulations are necessary to provide for the safety
of life on navigable waters during the event. This action is intended
to temporarily restrict vessel traffic in a portion of the Potomac
River during the event.

DATES: This rule is effective and will be enforced from 10 a.m. until
2:30 p.m. on June 2, 2012.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2011-1176 and are available online by going to
http://www.regulations.gov, inserting USCG-2011-1176 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590, 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 rule, call or email Mr. Ronald Houck, U.S. Coast Guard Sector
Baltimore, MD; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
If you have questions on viewing the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On February 9, 2012, we published a notice of proposed rulemaking
(NPRM) entitled ``Special Local Regulations for Marine Events; Potomac
River, Charles County, MD'' in the Federal Register (77 FR 27). We
received one comment on the proposed rule. No public meeting was
requested, and none was held.

Background and Purpose

    On June 2, 2012, Enviro-Sports Productions, Inc. of Stinson Beach,
California, will sponsor an amateur swim across the Potomac River
between Newburg, Maryland and King George, VA. The event consists of up
to 500 swimmers on a course located upriver and parallel to the
Governor Harry W. Nice Memorial (US-301) Bridge. The swimmers will be
supported by sponsor-provided watercraft. The start will be located
along the shore at the Aqua-Land Marina and the finish will be located
along the shore at Dahlgren Wayside Park. A portion of the swim course
will cross the federal navigation channel. Due to the need for vessel
control during the event, the Coast Guard will temporarily restrict
vessel traffic in the event area to provide for the safety of
participants, spectators and other transiting vessels.

Discussion of Comments and Changes

    The Coast Guard received one comment in response to the NPRM. No
public meeting was requested and none was held. What follows is a
review of, and the Coast Guard's response to, the issue that was
presented by the commenter concerning the proposed regulations.
    The commenter, Mr. David R. Horning of EnviroSports, who is the
event organizer, stated that after further review of the tidal currents
for June 2, 2012, it has been determined that the best time to start
the swim event would be between 11:30 a.m. and 12 p.m. (Noon) to get
all participants across the Potomac River safely. Furthermore, the
timeline in the proposed regulation closing this portion of the Potomac

River should be adjusted to a time from 10 a.m. to 2:30 p.m.
    We feel that adjusting the effective period in the proposed rule as
suggested by the commenter will not adversely affect waterway users in
this portion of the Potomac River on June 2, 2012.

Regulatory Analyses

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

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. We expect the economic
impact of this rule to be so minimal that a full Regulatory Evaluation
under the regulatory policies and procedures of DHS is unnecessary.
Although this regulation will prevent traffic from transiting a portion
of the Potomac River during the event, the effect of this regulation
will not be significant due to the limited duration that the regulated
area will be in effect and the extensive advance notifications that
will be made to the maritime community via the Local Notice to Mariners
and marine information broadcasts, so mariners can adjust their plans
accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule would affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to transit or anchor in the effected portions of the Potomac River
during the event.
    Although this regulation prevents traffic from transiting a portion
of the Potomac River near the Governor Harry W. Nice Memorial (US-301)
Bridge during the event, this rule will not have a significant economic
impact on a substantial number of small entities for the following
reasons. This rule will be in effect for only a limited period. Though
the regulated area extends across the entire width of the river, vessel
traffic may be permitted to safely transit a portion of the regulated
area, but only after all participants have safely cleared that portion
of the regulated area and when the Coast Guard Patrol Commander deems
it safe for vessel traffic to do so. All Coast Guard vessels enforcing
this regulated area can be contacted on marine band radio VHF-FM
channel 16 (156.8 MHz). Before the enforcement period, we will issue
maritime advisories so mariners can adjust their plans accordingly.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

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

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

Protest Activities

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    This action is not a ``significant energy action'' under Executive
Order

13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use.

Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(h), of the Instruction. This rule involves implementation of
regulations within 33 CFR part 100 applicable to organized marine
events on the navigable waters of the United States that could
negatively impact the safety of waterway users and shore side
activities in the event area. The category of water activities includes
but is not limited to sail boat regattas, boat parades, power boat
racing, swimming events, crew racing, canoe and sail board racing. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard
temporarily amends 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. Add temporary Sec.  100.35T05-1176 to read as follows:

Sec.  100.35T05-1176  Special Local Regulations for Marine Events;
Potomac River, Charles County, MD.

    (a) Regulated area. The following location is a regulated area: All
waters of the Potomac River, within lines connecting the following
positions: From latitude 38[deg]22'05'' N, longitude 076[deg]59'03'' W,
thence to latitude 38[deg]21'50'' N, longitude 077[deg]00'54'' W, and
from latitude 38[deg]21'29'' N, longitude 077[deg]00'54'' W to latitude
38[deg]21'45'' N, longitude 076[deg]58'59'' W. All coordinates
reference Datum NAD 1983.
    (b) Definitions. (1) Coast Guard Patrol Commander means a
commissioned, warrant, or petty officer of the U.S. Coast Guard who has
been designated by the Commander, Coast Guard Sector Baltimore.
    (2) Official Patrol means any vessel assigned or approved by
Commander, Coast Guard Sector Baltimore with a commissioned, warrant,
or petty officer on board and displaying a Coast Guard ensign.
    (c) Special local regulations. (1) The Coast Guard Patrol Commander
may forbid and control the movement of all vessels and persons in the
regulated area. When hailed or signaled by an official patrol vessel, a
vessel or person in the regulated area shall immediately comply with
the directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both.
    (2) All Coast Guard vessels enforcing this regulated area can be
contacted at telephone number<PHONE_NUMBER> or on marine band radio VHF-
FM channel 16 (156.8 MHz).
    (3) The Coast Guard will publish a notice in the Fifth Coast Guard
District Local Notice to Mariners and issue a marine information
broadcast on VHF-FM marine band radio announcing specific event date
and times.
    (d) Enforcement period. This section will be enforced from 10 a.m.
to 2:30 p.m. on June 2, 2012.

    Dated: March 30, 2012.
Mark P. O'Malley,
Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2012-9518 Filed 4-19-12; 8:45 am]
BILLING CODE 9110-04-P


Ron Evans/RTP/USEPA/US

03/10/2008 04:05 PM

To

"King, Heidi R."<EMAIL_ADDRESS> cc

Al McGartland/DC/USEPA/US@EPA, Cynthia Morgan/DC/USEPA/US@EPA, Elizabeth Kopits/DC/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA, "Johansson, Robert"<EMAIL_ADDRESS>Tricia Crabtree/RTP/USEPA/US@EPA, Jim Ketcham-Colwill<EMAIL_ADDRESS>darryl weatherhead<EMAIL_ADDRESS>Charles Fulcher/RTP/USEPA/US@EPA, Janet Cakir/RTP/USEPA/US@EPA

Subject

revision to presentation of cost results in chapter 5

Heidi,

In consultation with OPEI, we have revised the presentation of the total costs in chapter 5.   What you will find is an additional paragraph (and footnote to table 5.1) we have put together to point out that our current approach relies on technological change to keep costs from becoming too expensive.   The paragraph points out that an alternative storyline might hypothesize a much less optimistic technological change path, such that emissions reductions technologies for industrial sources would be more expensive or would be unavailable.  We will be happy to discuss this new wording when we talk to you about your questions on the cost section.

Ron Evans

Leader, Air Benefit & Cost Group

HEID/OAQPS/OAR/EPA

Mail Drop C-439-02

919-541-5488

919-541-0839 fax

We do one thing: overwhelm people's impossible expectations.


[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Notices]
[Page 17546]
[DOCID:fr09ap07-65]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-376-000]

Transcontinental Gas Pipe Line Corporation; Notice of
Authorization and Waiver

April 3, 2007.
    Take notice that on March 30, 2007, Transcontinental Gas Pipe Line
Corporation (Transco) seeks authorization from the Commission to use
the posting and bid evaluation procedures in Section 43 of the General
Terms & Conditions of its FERC Gas Tariff (GT&C) to sell certain excess
top gas inventory. In conjunction with such sale, Transco requests that
the Commission grant waiver of Section 43.5 of the GT&C in order for
Transco to recognize the appropriate accounting from the sale in its
gas inventory account.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time April 11, 2007.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6572 Filed 4-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55061-55064]
[FR Doc No: 2023-17346]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2023-0002; Internal Agency Docket No. FEMA-B-2361]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The currently effective community number is shown in the
table below and must be used for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Nicholas A. Shufro,
Deputy Assistant Administrator for Risk Management, Federal Emergency
Management Agency, Department of Homeland Security.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Chief executive officer of                                    Online location of letter of map                            Community
         State and county          Location and case No.             community               Community map repository                 revision                Date of modification       No.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama:
    Madison......................  City of Huntsville     The Honorable Thomas Battle     City Hall, 308 Fountain        https://msc.fema.gov/portal/        Oct. 5, 2023..........       010153
                                    (23-04-2057P).         Jr., Mayor, City of             Circle, Huntsville, AL         advanceSearch.
                                                           Huntsville, 308 Fountain        35801.
                                                           Circle, 8th Floor,
                                                           Huntsville, AL 35801.
Colorado:
    Gilpin.......................  City of Black Hawk     The Honorable David D.          Community Planning and         https://msc.fema.gov/portal/        Sep. 22, 2023.........       080076
                                    (22-08-0228P).         Spellman, Mayor, City of        Development Department, 211    advanceSearch.
                                                           Black Hawk, P.O. Box 68,        Church Street, Black Hawk,
                                                           Black Hawk, CO 80422.           CO 80422.
    Gilpin.......................  City of Central City   The Honorable Jeremy Fey,       City Hall, 141 Nevada Street,  https://msc.fema.gov/portal/        Sep. 22, 2023.........       080077
                                    (22-08-0228P).         Mayor, City of Central City,    Central City, CO 80427.        advanceSearch.
                                                           P.O. Box 249, Central City,
                                                           CO 80427.
Florida:
    Brevard......................  City of Palm Bay (22-  The Honorable Rob Medina,       Building Department, 190       https://msc.fema.gov/portal/        Oct. 6, 2023..........       120404
                                    04-2818P).             Mayor, City of Palm Bay, 120    Malabar Road Southwest,        advanceSearch.
                                                           Malabar Road, Palm Bay, FL      Suite 105, Palm Bay, FL
                                                           32907.                          32908.
    Hillsborough.................  City of Plant City     Bill McDaniel, Manager, City    City Hall, 302 West Reynolds   https://msc.fema.gov/portal/        Oct. 26, 2023.........       120113
                                    (23-04-2405P).         of Plant City, 302 West         Street, Plant City, FL         advanceSearch.
                                                           Reynolds Street, Plant City,    33563.
                                                           FL 33563.
    Hillsborough.................  City of Tampa (21-04-  John Bennett, Chief of Staff,   Construction Services          https://msc.fema.gov/portal/        Oct. 23, 2023.........       120114
                                    0665P).                City of Tampa, 306 East         Department, 1400 North         advanceSearch.
                                                           Jackson Street, Tampa, FL       Boulevard, Tampa, FL 33607.
                                                           33602.
    Hillsborough.................  Unincorporated areas   Bonnie Wise, Hillsborough       Hillsborough County Center,    https://msc.fema.gov/portal/        Oct. 23, 2023.........       120112
                                    of Hillsborough        County Administrator, 601       601 East Kennedy Boulevard,    advanceSearch.
                                    County (21-04-         East Kennedy Boulevard, 26th    22nd Floor, Tampa, FL 33602.
                                    0665P).                Floor, Tampa, FL 33602.
    Hillsborough.................  Unincorporated areas   Bonnie Wise, Hillsborough       Hillsborough County Center,    https://msc.fema.gov/portal/        Oct. 12, 2023.........       120112
                                    of Hillsborough        County Administrator, 601       601 East Kennedy Boulevard,    advanceSearch.
                                    County (23-04-         East Kennedy Boulevard, 26th    22nd Floor, Tampa, FL 33602.
                                    1767P).                Floor, Tampa, FL 33602.
    Lake.........................  City of Leesburg (22-  Al Minner, Manager, City of     Public Works Department, 501   https://msc.fema.gov/portal/        Sep. 25, 2023.........       120136
                                    04-3930P).             Leesburg, P.O. Box 490630,      West Meadow Street,            advanceSearch.
                                                           Leesburg, FL 34749.             Leesburg, FL 34748.
    Lake.........................  Unincorporated areas   Jennifer Barker, Lake County    Lake County Public Works       https://msc.fema.gov/portal/        Sep. 25, 2023.........       120421
                                    of Lake County (22-    Manager, P.O. Box 7800,         Department, 323 North          advanceSearch.
                                    04-3930P).             Tavares, FL 32778.              Sinclair Avenue, Tavares, FL
                                                                                32778.
    Manatee......................  Unincorporated areas   Lee Washington, Manatee County  Manatee County Administration  https://msc.fema.gov/portal/        Sep. 25, 2023.........       120153
                                    of Manatee County      Administrator, 1112 Manatee     Building, 1112 Manatee         advanceSearch.
                                    (23-04-0814P).         Avenue West, Bradenton, FL      Avenue West, Bradenton, FL
                                                           34205.                          34205.
    Monroe.......................  Unincorporated areas   The Honorable Craig Cates,      Monroe County Building         https://msc.fema.gov/portal/        Sep. 11, 2023.........       125129
                                    of Monroe County (23-  Mayor, Monroe County Board of   Department, 2798 Overseas      advanceSearch.
                                    04-2258P).             Commissioners, 500 Whitehead    Highway, Suite 300,
                                                           Street, Suite 102, Key West,    Marathon, FL 33050.
                                                           FL 33040.
    Orange.......................  Unincorporated areas   The Honorable Jerry L.          Orange County Public Works     https://msc.fema.gov/portal/        Sep. 22, 2023.........       120179
                                    of Orange County (21-  Demings, Mayor, Orange          Department, Stormwater         advanceSearch.
                                    04-3684P).             County, 201 South Rosalind      Management Division, 4200
                                                           Avenue, 5th Floor, Orlando,     South John Young Parkway,
                                                           FL 32801.                       Orlando, FL 32839.
    Palm Beach...................  Unincorporated areas   Verdenia C. Baker, Palm Beach   Palm Beach County Building     https://msc.fema.gov/portal/        Oct. 2, 2023..........       120192
                                    of Palm Beach County   County Administrator, 301       Division, Planning, Zoning     advanceSearch.
                                    (22-04-3946P).         North Olive Avenue, West Palm   and Building Department,
                                                           Beach, FL 33401.                2300 North Jog Road, West
                                                                                Palm Beach, FL 33411.
    Pinellas.....................  City of Clearwater     The Honorable Brian Aungst,     City Hall, 100 South Myrtle    https://msc.fema.gov/portal/        Sep. 28, 2023.........       125096
                                    (23-04-0224P).         Sr., Mayor, City of             Avenue, Clearwater, FL         advanceSearch.
                                                           Clearwater, 600 Cleveland       33756.
                                                           Street, 6th Floor,
                                                           Clearwater, FL 33756.

    Polk.........................  Unincorporated areas   Bill Beasley, Polk County       Polk County Land Development   https://msc.fema.gov/portal/        Oct. 26, 2023.........       120261
                                    of Polk County (22-    Manager, 330 West Church        Division, 330 West Church      advanceSearch.
                                    04-4292P).             Street, Bartow, FL 33831.       Street, Bartow, FL 33831.
    Polk.........................  Unincorporated areas   Bill Beasley, Polk County       Polk County Land Development   https://msc.fema.gov/portal/        Oct. 26, 2023.........       120261
                                    of Polk County (23-    Manager, 330 West Church        Division, 330 West Church      advanceSearch.
                                    04-0252P).             Street, Bartow, FL 33831.       Street, Bartow, FL 33831.
    Sumter.......................  City of Wildwood (22-  The Honorable Ed Wolf, Mayor,   Sumter County Service Center,  https://msc.fema.gov/portal/        Sep. 22, 2023.........       120299
                                    04-4208P).             City of Wildwood, 100 North     7375 Powell Road, Wildwood,    advanceSearch.
                                                           Main Street, Wildwood, FL       FL 34785.
                                                           34785.
    Sumter.......................  Unincorporated areas   Bradley Arnold, Sumter County   Sumter County Service Center,  https://msc.fema.gov/portal/        Sep. 22, 2023.........       120296
                                    of Sumter County (22-  Administrator, 7375 Powell      7375 Powell Road, Wildwood,    advanceSearch.
                                    04-4208P).             Road, Wildwood, FL 34785.       FL 34785.
Georgia:
    DeKalb.......................  Unincorporated areas   Michael L Thurmond, Chief       DeKalb County Roads and        https://msc.fema.gov/portal/        Sep. 22, 2023.........       130065
                                    of DeKalb County (23-  Executive Officer, DeKalb       Drainage Department, 727       advanceSearch.
                                    04-0174P).             County, 1300 Commerce Drive,    Camp Road, Decatur, GA
                                                           6th Floor, Decatur, GA 30030.   30032.
Kentucky:
    Boyd.........................  Unincorporated areas   The Honorable Eric Chaney,      Boyd County Code Enforcement   https://msc.fema.gov/portal/        Oct. 16, 2023.........       210016
                                    of Boyd County (22-    Judge Executive, Boyd County,   Department, 2800 Louisa        advanceSearch.
                                    04-5324P).             2800 Louisa Street,             Street, Catlettsburg, KY
                                                           Catlettsburg, KY 41129.         41129.
Maryland:
    Montgomery...................  Unincorporated areas   Marc Elrich, Montgomery County  Montgomery County Department   https://msc.fema.gov/portal/        Sep. 25, 2023.........       240049
                                    of Montgomery County   Executive, 101 Monroe Street,   of Permitting Services, 2425   advanceSearch.
                                    (22-03-0958P).         2nd Floor, Rockville, MD        Reedie Drive, 7th Floor,
                                                           20850.                          Wheaton, MD 20902.
New Mexico:
    Bernalillo...................  City of Albuquerque    The Honorable Tim Keller,       City Hall, 1 Civic Plaza       https://msc.fema.gov/portal/        Oct. 23, 2023.........       350002
                                    (22-06-2510P).         Mayor, City of Albuquerque, 1   Northwest, Albuquerque, NM     advanceSearch.
                                                           Civic Plaza Northwest,          87102.
                                                           Albuquerque, NM 87102.
    Bernalillo...................  Unincorporated areas   Barbara Baca, Chair,            Bernalillo County at Alvarado  https://msc.fema.gov/portal/        Oct. 23, 2023.........       350001
                                    of Bernalillo County   Bernalillo County Board of      Square, 415 Silver Avenue      advanceSearch.
                                    (22-06-2510P).         Commissioners, 415 Silver       Southwest, Albuquerque, NM
                                                           Avenue Southwest,               87102.
                                                           Albuquerque, NM 87102.
South Carolina:
    Berkeley.....................  Unincorporated areas   Johnny Cribb, Berkeley County   Berkeley County Planning and   https://msc.fema.gov/portal/        Sep. 21, 2023.........       450029
                                    of Berkeley County     Supervisor, 1003 Highway 52,    Zoning Department, 1003        advanceSearch.
                                    (22-04-5274P).         Moncks Corner, SC 29461.        Highway 52, Moncks Corner,
                                                                                SC 29461.
Texas:
    Bexar........................  Unincorporated areas   The Honorable Peter Saki,       Bexar County Public Works      https://msc.fema.gov/portal/        Sep. 25, 2023.........       480035
                                    of Bexar County (22-   Bexar County Judge, 101 West    Department, 1948 Probandt      advanceSearch.
                                    06-2152P).             Nueva Street, 10th Floor, San   Street, San Antonio, TX
                                                           Antonio, TX 78205.              78205.
    Collin.......................  City of Wylie (23-06-  The Honorable Matthew Porter,   City Hall, 300 Country Club    https://msc.fema.gov/portal/        Oct. 12, 2023.........       480759
                                    0077P).                Mayor, City of Wylie, 300       Road, Building 100, Wylie,     advanceSearch.
                                                           Country Club Road, Building     TX 75098.
                                                           100, Wylie, TX 75098.
    Collin.......................  Town of Prosper (22-   The Honorable David F.          Town Hall, 250 West 1st        https://msc.fema.gov/portal/        Sep. 11, 2023.........       480141
                                    06-2792P).             Bristol, Mayor, Town of         Street, Prosper, TX 75078.     advanceSearch.
                                                           Prosper, 250 West 1st Street,
                                                           Prosper, TX 75078.
    Collin.......................  Unincorporated areas   The Honorable Chris Hill,       Collin County Engineering      https://msc.fema.gov/portal/        Oct. 12, 2023.........       480130
                                    of Collin County (23-  Collin County Judge, 2300       Department, 4690 Community     advanceSearch.
                                    06-0077P).             Bloomdale Road, Suite 4192,     Avenue, Suite 200, McKinney,
                                                           McKinney, TX 75071.             TX 75071.
    Denton.......................  City of Fort Worth     The Honorable Mattie Parker,    T/PW Engineering Vault, 200    https://msc.fema.gov/portal/        Sep. 25, 2023.........       480596
                                    (23-06-0297P).         Mayor, City of Fort Worth,      Texas Street, Fort Worth, TX   advanceSearch.
                                                           200 Texas Street, Fort Worth,   76102.
                                                           TX 76102.

    Ellis........................  City of Grand Prairie  The Honorable Ron Jensen,       City Hall, 300 West Main       https://msc.fema.gov/portal/        Sep. 14, 2023.........       485472
                                    (22-06-2534P).         Mayor, City of Grand Prairie,   Street, Grand Prairie, TX      advanceSearch.
                                                           P.O. Box 534045, Grand          75050.
                                                           Prairie, TX 75053.
    Ellis........................  Unincorporated areas   The Honorable Todd Little,      Ellis County Courts and        https://msc.fema.gov/portal/        Oct. 19, 2023.........       480798
                                    of Ellis County (22-   Ellis County Judge, 101 West    Administration, 109 South      advanceSearch.
                                    06-2111P).             Main Street, Waxahachie, TX     Jackson Street, Waxahachie,
                                                           75165.                          TX 75165.
    Ellis........................  Unincorporated areas   The Honorable Todd Little,      Ellis County Courts and        https://msc.fema.gov/portal/        Sep. 14, 2023.........       480798
                                    of Ellis County (22-   Ellis County Judge, 101 West    Administration, 109 South      advanceSearch.
                                    06-2534P).             Main Street, Waxahachie, TX     Jackson Street, Waxahachie,
                                                           75165.                          TX 75165.
    Hays.........................  Unincorporated areas   The Honorable Ruben Becerra,    Hays County Development        https://msc.fema.gov/portal/        Sep. 28, 2023.........       480321
                                    of Hays County (23-    Hays County Judge, 111 East     Services Department, 2171      advanceSearch.
                                    06-0307P).             San Antonio Street, Suite       Yarrington Road, Suite 100,
                                                           300, San Marcos, TX 78666.      Kyle, TX 78640.
    Kaufman......................  Unincorporated areas   The Honorable Jakie Allen,      Kaufman County Development     https://msc.fema.gov/portal/        Sep. 29, 2023.........       480411
                                    of Kaufman County      Kaufman County Judge, 1902      Services Department, 106       advanceSearch.
                                    (23-06-0527P).         East U.S. Highway 175,          West Grove Street, Kaufman,
                                                           Kaufman, TX 75142.              TX 75142.
    Tarrant......................  City of Arlington (23- The Honorable Jim Ross, Mayor,  Public Works and               https://msc.fema.gov/portal/        Sep. 18, 2023.........       485454
                                    06-0354P).             City of Arlington, P.O. Box     Transportation Department,     advanceSearch.
                                                           90231, Arlington, TX 76004.     101 West Abram Street,
                                                                                Arlington, TX 76004.
    Tarrant......................  City of Fort Worth     The Honorable Mattie Parker,    Transportation and Public      https://msc.fema.gov/portal/        Sep. 18, 2023.........       480596
                                    (23-06-0306P).         Mayor, City of Fort Worth,      Works Department,              advanceSearch.
                                                           200 Texas Street, Fort Worth,   Engineering Vault, 200 Texas
                                                           TX 76102.                       Street, Fort Worth, TX
                                                                                76102.
    Tarrant......................  City of Fort Worth     The Honorable Mattie Parker,    Transportation and Public      https://msc.fema.gov/portal/        Sep. 25, 2023.........       480596
                                    (23-06-0361P).         Mayor, City of Fort Worth,      Works Department,              advanceSearch.
                                                           200 Texas Street, Fort Worth,   Engineering Vault, 200 Texas
                                                           TX 76102.                       Street, Fort Worth, TX
                                                                                76102.
    Tarrant......................  City of Haltom City    The Honorable An Truong,        Public Works Department, 4200  https://msc.fema.gov/portal/        Sep. 18, 2023.........       480599
                                    (23-06-0193P).         Mayor, City of Haltom City,     Hollis Street, Haltom City,    advanceSearch.
                                                           5024 Broadway Avenue, Haltom    TX 76111.
                                                           City, TX 76117.
    Tarrant......................  Unincorporated areas   The Honorable Tim O'Hare,       Tarrant County Administration  https://msc.fema.gov/portal/        Sep. 18, 2023.........       480582
                                    of Tarrant County      Tarrant County Judge, 100       Building, 100 East             advanceSearch.
                                    (23-06-0306P).         East Weatherford Street,        Weatherford Street, Fort
                                                           Suite 501, Fort Worth, TX       Worth, TX 76196.
                                                           76196.
    Williamson...................  City of Round Rock     The Honorable Craig Morgan,     Utilities and Environmental    https://msc.fema.gov/portal/        Oct. 16, 2023.........       481048
                                    (22-06-2322P).         Mayor, City of Round Rock,      Services Department, 3400      advanceSearch.
                                                           221 East Main Street, Round     Sunrise Road, Round Rock, TX
                                                           Rock, TX 78664.                 78665.
    Wise.........................  City of New Fairview   The Honorable John R. Taylor,   Public Works Department, 999   https://msc.fema.gov/portal/        Sep. 22, 2023.........       481629
                                    (23-06-0882P).         Mayor, City of New Fairview,    Illinois Lane, New Fairview,   advanceSearch.
                                                           999 Illinois Lane, New          TX 76078.
                                                           Fairview, TX 76078.
    Wise.........................  Unincorporated areas   The Honorable J.D. Clark, Wise  Wise County Public Works       https://msc.fema.gov/portal/        Sep. 22, 2023.........       481051
                                    of Wise County (23-    County Judge, 101 North         Department, 2901 South F.M.    advanceSearch.
                                    06-0882P).             Trinity Street, Decatur, TX     51, Building 100, Decatur,
                                                           76234.                          TX 76234.
Virginia:
    Independent City.............  City of Fairfax (22-   Robert A. Stalzer, City of      Public Works Department,       https://msc.fema.gov/portal/        Oct. 2, 2023..........       515524
                                    03-1047P).             Fairfax Manager, 10455          10455 Armstrong Street, Room   advanceSearch.
                                                           Armstrong Street, Room 316,     200, Fairfax, VA 22030.
                                                           Fairfax, VA 22030.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2023-17346 Filed 8-11-23; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: September 24, 2009 (Volume 74, Number 184)]
[Notices]
[Page 48726-48727]
[DOCID:fr24se09-41]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12462-020]

Indian River Power Supply, LLC; Notice of Application for
Amendment of License and Soliciting Comments, Motions To Intervene, and
Protests

September 17, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Amendment of License.
    b. Project No.: 12462-020.
    c. Date Filed: August 5, 2009.
    d. Applicant: Indian River Power Supply, LLC.
    e. Name of Project: Indian River.
    f. Location: Westfield River, in the Town of Russell, Hampden
County, Massachusetts.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Peter B. Clark, Manager, P.O. Box 149,
823 Bay Road, Hamilton, Massachusetts,<PHONE_NUMBER>.
    i. FERC Contact: Jeremy Jessup<EMAIL_ADDRESS>(202) 502-
6779.
    j. Deadline for filing comments, motions to intervene and protest:
October 17, 2009.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    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 whose name appears on 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. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Request: Indian River Power Supply, LLC, proposes
to rehabilitate the project's existing generating Unit 1. The
rehabilitated unit would have an installed capacity of 800 kW and a
hydraulic capacity of 428 cfs. The rehabilitation would result in a
total installed capacity of 1,600 kW and a total hydraulic capacity of
856 cfs for the Indian River Project.
    l. Location of the Application: The filing is available for
inspection and reproduction at the Commission's Public Reference Room,
located at 888 First Street, NE., Room 2A, Washington, DC 20426 or by
calling<PHONE_NUMBER>, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docsfiling/esubscription.asp to
be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 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. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. 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.
    o. Any filing must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. 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.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(I)(iii) and
the instructions on the Commission's Web

site at http://www.ferc.gov under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-22994 Filed 9-23-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 16, 2007 (Volume 72, Number 199)]
[Rules and Regulations]
[Page 58535-58538]
[DOCID:fr16oc07-17]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2007-0718; FRL-8483-1]

Approval and Promulgation of State Implementation Plans and
Operating Permits Program; State of Iowa

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is approving revisions to the Iowa State Implementation
Plan (SIP) and Operating Permits Program submitted by the state of
Iowa. These revisions update and clarify various rules and make minors
revisions and corrections. Approval of these revisions will ensure
consistency between the state and Federally-approved rules, and ensure
Federal enforceability of the State's revised air program rules.

DATES: This direct final rule will be effective December 17, 2007,
without further notice, unless EPA receives adverse comment by November
15, 2007. If adverse comment is received, EPA will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2007-0718, by one of the following methods:
    1. http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Heather Hamilton, Environmental Protection Agency, Air
Planning and Development Branch, 901 North 5th Street, Kansas City,
Kansas 66101.
    4. Hand Delivery or Courier: Deliver your comments to Heather
Hamilton, Environmental Protection Agency, Air Planning and Development
Branch, 901 North 5th Street, Kansas City, Kansas 66101.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2007-0718. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

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

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

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

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

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

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

FOR FURTHER INFORMATION CONTACT: Heather Hamilton at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This section provides
additional information by addressing the following questions:

What is a SIP?
What is the Federal approval process for a SIP?
What does Federal approval of a state regulation mean to me?
What is the Part 70 operating permits program?
What is the Federal approval process for an operating permits
program?
What is being addressed in this document?
Have the requirements for approval of a SIP revision and a Part 70
revision been met?
What action is EPA taking?

What is a SIP?

    Section 110 of the Clean Air Act (CAA) requires states to develop
air pollution regulations and control strategies to ensure that state
air quality meets the national ambient air quality standards
established by EPA. These ambient standards are established under
section 109 of the CAA, and they currently address six criteria
pollutants. These pollutants are: Carbon monoxide, nitrogen dioxide,
ozone, lead, particulate matter, and sulfur dioxide.
    Each state must submit these regulations and control strategies to
us for approval and incorporation into the Federally-enforceable SIP.
Each Federally-approved SIP protects air quality primarily by
addressing air pollution at its point of origin. These SIPs can be
extensive, containing state regulations or other enforceable documents
and supporting information such as emission inventories, monitoring
networks, and modeling demonstrations.

What is the Federal approval process for a SIP?

    In order for state regulations to be incorporated into the
Federally-enforceable SIP, states must formally adopt the regulations
and control strategies consistent with state and Federal requirements.
This process generally includes a public notice, public hearing, public
comment period, and a formal adoption by a state-authorized rulemaking
body.
    Once a state rule, regulation, or control strategy is adopted, the
state submits it to us for inclusion into the SIP. We must provide
public notice and seek additional public comment regarding the proposed
Federal action on the state submission. If adverse comments are
received, they must be addressed prior to any final Federal action by
us.
    All state regulations and supporting information approved by EPA
under section 110 of the CAA are incorporated into the Federally-
approved SIP. Records of such SIP actions are maintained in the Code of
Federal Regulations (CFR) at title 40, part 52, entitled ``Approval and
Promulgation of Implementation Plans.'' The actual state regulations
which are approved are not reproduced in their entirety in the CFR
outright but are ``incorporated by reference,'' which means that we
have approved a given state regulation with a specific effective date.

What does Federal approval of a state regulation mean to me?

    Enforcement of the state regulation before and after it is
incorporated into the Federally-approved SIP is primarily a state
responsibility. However, after the regulation is Federally approved, we
are authorized to take enforcement action against violators. Citizens
are also offered legal recourse to address violations as described in
section 304 of the CAA.

What is the Part 70 operating permits program?

    The CAA Amendments of 1990 require all states to develop operating
permits programs that meet certain Federal criteria. In implementing
this program, the states are to require certain sources of air
pollution to obtain permits that contain all applicable requirements
under the CAA. One purpose of the part 70 operating permits program is
to improve enforcement by issuing each source a single permit that
consolidates all of the applicable CAA requirements into a Federally-
enforceable document. By consolidating all of the applicable
requirements for a facility into one document, the source, the public,
and the permitting authorities can more easily determine what CAA
requirements apply and how compliance with those requirements is
determined.
    Sources required to obtain an operating permit under this program
include ``major'' sources of air pollution and certain other sources
specified in the CAA or in our implementing regulations. For example,
all sources regulated under the acid rain program, regardless of size,
must obtain permits. Examples of major sources include those that emit
100 tons per year or more of volatile organic compounds, carbon
monoxide, lead, sulfur dioxide, nitrogen dioxide, or PM10;
those that emit 10 tons per year of any single hazardous air pollutant
(HAP) (specifically listed under the CAA); or those that emit 25 tons
per year or more of a combination of HAPs.
    Revision to the state operating permits program are also subject to
public notice, comment, and our approval.

What is the Federal approval process for an operating permits program?

    In order for state regulations to be included in the Federally-
enforceable Title V operating permits program, states must formally
adopt regulations consistent with state and Federal requirements. This
process generally includes a public notice, public hearing, public
comment period, and a formal adoption by a state-authorized rulemaking
body.
    Once a state rule, regulation, or control strategy is adopted, the
state submits it to us for inclusion into the approved operating
permits program. We must provide public notice and seek additional
public comment regarding the proposed Federal action on the state
submission. If adverse comments are received, they must be addressed
prior to any final Federal action by us.
    All state regulations and supporting information approved by EPA
under section 502 of the CAA, including revisions to the state program,
are included in the Federally-approved operating permits program.
Records of such actions are maintained in the CFR at Title 40, part 70,
appendix A, entitled ``Approval Status of State and Local Operating
Permits Programs.''

What is being addressed in this document?

    EPA is approving the State Implementation Plan (SIP) revisions
submitted by the state of Iowa which include minor revisions to various
rules. The state of Iowa periodically makes minor revisions that are
included under its general rulemaking and are typically processed twice
a year. The revisions are described as follows:
    With regard to Iowa's variance provision in subrule 21.2(4)``c'' of
the Iowa Administrative Code (IAC), the Iowa Department of Natural
Resources added language to clarify the Prevention of Significant
Deterioration (PSD) requirements for which they may not grant a
variance and referenced the new chapter in the Iowa Administrative Code
that addresses PSD requirements. The revision clarifies that variances
cannot be issued to sources seeking permit limits on their potential
emissions in order to avoid major source permitting requirements. In
other words, a variance cannot be issued to a source seeking a
synthetic minor permit.
    Revisions were made to subrules 22.201(2) and 22.300(3) which
address applicability of Iowa's synthetic minor permit program. The
revisions correct cross references to the state's rules for Title V
permits, Acid Rain permits and permits by rule for small sources. These
changes apply to the SIP and Iowa's operating permits program.
    Revisions were made to Chapter 25 of the IAC, relating to emissions
monitoring methods, to update references to Federal reference methods
and performance standards. These changes apply to SIP monitoring
requirements.

Have the requirements for approval of a SIP revision and a Part 70
revision been met?

    The state submittal has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submittal also
satisfied the completeness criteria of 40 CFR part 51, appendix V. In
addition, as explained above and in more detail in the technical
support document which is part of this docket, these revisions meet the
substantive SIP requirements of the CAA, including section 110 and
implementing regulations. These revisions are minor clarifications,
updates, and corrections which do not affect the stringency of existing
requirements. These revisions are also consistent with applicable EPA
requirements in Title V of the CAA and 40 CFR Part 70.

What action is EPA taking?

    EPA is approving these revisions submitted by Iowa on April 26,
2007, to update the SIP and the Iowa Operating Permits Program to
include minor revisions and updates. We are processing this action as a
direct final action because the revisions make routine changes to the
existing rules which are noncontroversial. We do not anticipate any
adverse comments. Please note that if EPA receives adverse comment on
part of this rule and if that part can be severed from the remainder of
the rule, EPA may adopt as final those parts of the rule that are not
the subject of an adverse comment.

Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this action will not have
a significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this action approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it 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).
    This action also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does 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 (64
FR 43255, August 10, 1999). This action merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the CAA.
This action also is not subject to Executive Order 13045, ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it approves a state rule implementing a
Federal standard.
    In reviewing state submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. In this
context, in the absence of a prior existing requirement for the State
to use voluntary consensus standards (VCS), EPA has no authority to
disapprove a state submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a state
submission, to use VCS in place of a state submission that otherwise
satisfies the provisions of the CAA. Thus, the requirements of section
12(d) of the National Technology Transfer and Advancement Act of 1995
(15 U.S.C. 272 note) do not apply. This action does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    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 action is not a ``major rule'' as defined
by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 17, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

40 CFR Part 70

    Administrative practice and procedure, Air pollution control,
Intergovernmental relations, Operating permits, Reporting and
recordkeeping requirements.

    Dated: October 5, 2007.
William Rice,
Acting Regional Administrator, Region 7.

0
Chapter I, title 40 of the Code of Federal Regulations is amended as
follows:

PART 52--[AMENDED]

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

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

Subpart Q--Iowa

0
2. In Sec.  52.820 the table in paragraph (c) is amended by revising
entries for 567-21.2, 567-22.201, 567-22.300, and 567-25.1, to read as
follows:

Sec.  52.820  Identification of plan.

* * * * *
    (c) * * *

                                         EPA.-Approved Iowa Regulations
----------------------------------------------------------------------------------------------------------------
                                                    State
     Iowa citation              Title          effective date    EPA approval date            Explanation
----------------------------------------------------------------------------------------------------------------
                 Iowa Department of Natural Resources Environmental Protection Commission [567]
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                             Chapter 21--Compliance
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
567-21.2..............  Variances............        04/04/07  10/16/07 [insert FR    ..........................
                                                                page number where
                                                                the document begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                        Chapter 22--Controlling Pollution
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
567-22.201............  Eligibility for              04/04/07  10/16/07 [insert FR    ..........................
                         Voluntary Operating                    page number where
                         Permits.                               the document begins].

                                                  * * * * * * *
567-22.300............  Operating Permit by          04/04/07  10/16/07 [insert FR    ..........................
                         Rule for Small                         page number where
                         Sources.                               the document begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                      Chapter 25--Measurement of Emissions
----------------------------------------------------------------------------------------------------------------
567-25.1..............  Testing and Sampling         04/04/07  10/16/07 [insert FR    ..........................
                         of New and Existing                    page number where
                         Equipment.                             the document begins].

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

* * * * *

PART 70--[AMENDED]

0
3. The authority citation for Part 70 continues to read as follows:

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

0
4. Appendix A to Part 70 is amended by adding paragraph (i) under
``Iowa'' to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *
    Iowa
* * * * *
    (i) The Iowa Department of Natural Resources submitted for
program approval rules 567-22.105(2), 567-22.106(6), 567-22.201(2),
567-22.300(3) on April 19, 2007. The state effective date was April
4, 2007. These revisions to the Iowa program are approved effective
December 17, 2007.
* * * * *
 [FR Doc. E7-20378 Filed 10-15-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Pages 8727-8728]
[FR Doc No: 2019-04283]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0370]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Agency Information Collection Activities; Submission
for Office of Management and Budget Review; Comment Request; Export of
Medical Devices; Foreign Letters of Approval

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on reporting requirements for firms that
intend to export certain unapproved medical devices.

DATES: Submit either electronic or written comments on the collection
of information by May 10, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 10, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 10, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0370 for ``Export of Medical Devices; Foreign Letters of
Approval.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://

www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Export of Medical Devices; Foreign Letters of Approval

OMB Control Number 0910-0264--Extension

    Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 381(e)(2)) provides for the exportation of an
unapproved device under certain circumstances if the exportation is not
contrary to the public health and safety and it has the approval of the
foreign country to which it is intended for export. Requesters
communicate (either directly or through a business associate in the
foreign country) with a representative of the foreign government to
which they seek exportation, and written authorization must be obtained
from the appropriate office within the foreign government approving the
importation of the medical device. An alternative to obtaining written
authorization from the foreign government is to accept a notarized
certification from a responsible company official in the United States
that the product is not in conflict with the foreign country's laws.
This certification must include a statement acknowledging that the
responsible company official making the certification is subject to the
provisions of 18 U.S.C. 1001. This statutory provision makes it a
criminal offense to knowingly and willingly make a false or fraudulent
statement, or make or use a false document, in any manner within the
jurisdiction of a department or Agency of the United States. The
respondents to this collection of information are companies that seek
to export medical devices. FDA's estimate of the reporting burden is
based on the experience of FDA's medical device program personnel.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                       Number of        Number of       Total annual   Average  burden                    operating and
             Activity/FD&C Act section                respondents     responses per      responses      per  response     Total hours      maintenance
                                                                        respondent                                                            costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign letter of approval--801(e)(2).............              33                1               33                3               99           $8,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    We have adjusted our burden estimate by decreasing the number of
respondents by 5, which has resulted in a corresponding decrease of 15
hours to the currently approved hour burden and $1,250 to the total
operating and maintenance costs. This adjustment is based on a decrease
in the number of submissions we received over the last few years.

    Dated: March 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04283 Filed 3-8-19; 8:45 am]
BILLING CODE 4164-01-P