[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Pages 9203-9204]
[FR Doc No: 2016-03909]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0530]

Request for Expressions of Interest From Coverage Organizations;
Coverage Organizations Interested in Providing Input Regarding Private
Payer Coverage to Medical Device Sponsors Who Request Their
Participation in a Pre-Submission Meeting With the Food and Drug
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for expressions of interest.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
expressions of interest from organizations that evaluate clinical
evidence used to support private payer coverage decisions for medical
devices (coverage organizations) that wish to provide input to medical
device developers (sponsors) on clinical trial design or other plans
for gathering clinical evidence needed to support positive coverage
decisions. These coverage organizations include third-party commercial
health insurance organizations, payer/provider organizations, health
technology assessment groups and various organizations that evaluate
clinical evidence and make coverage recommendations to and decisions
for private payers and health plans. The Center for Devices and
Radiological Health (CDRH) is taking this step to assist sponsors in
identifying such organizations and soliciting clinical trial design or
other evidence-gathering input from them.
    If coverage organizations express interest, FDA intends to provide
a mechanism for such organizations to identify themselves so that
medical device sponsors who would like to obtain coverage input can
voluntarily contact them to participate in a FDA Pre-Submission
meeting. Early input from payers regarding their evidentiary needs can
streamline the process from FDA approval or clearance to payer coverage
and improve public health by facilitating earlier access to innovative,
safe, and effective medical devices.

DATES: This notice will be effective February 24, 2016.

ADDRESSES: Expressions of interest should be emailed to<EMAIL_ADDRESS>and contain the subject line ``Expression of
Interest in Providing Input Regarding Private Payer Coverage to Medical
Device Sponsors.'' The body of the email should contain your
organization's name, email, and mailing address.

FOR FURTHER INFORMATION CONTACT: CDRH Innovation, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5410, Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The mission of CDRH is to protect and promote public health. This
is accomplished in part by fulfilling its vision that patients in the
U.S. have access to safe and effective high quality medical devices of
public health importance first in the world.
    In the September 17, 2010, Federal Register notice (75 FR 57045),
the Centers for Medicare and Medicaid Services (CMS) and FDA introduced
Parallel Review, which is intended to reduce the time between FDA
marketing approval or clearance and CMS's National Coverage
Determinations (NCDs). As part of that program, sponsors met with FDA
and CMS at various times, to discuss the type of clinical evidence that
would support positive decisions by each agency. The Parallel Review
process improves the public health and quality of patient care by
facilitating earlier access to innovative medical devices for Medicare
beneficiaries. Based in part on the lessons learned from the Parallel
Review program and from Pre-Submission meetings involving CMS, FDA
found that early input from payers regarding their evidentiary needs
can streamline the process from FDA approval or clearance to payer
coverage.
    CDRH wishes to facilitate the voluntary inclusion, by sponsors in
their Pre-Submission meetings, of those organizations that evaluate
clinical evidence used to support private payer coverage determinations
for medical devices (coverage organizations), so that sponsors can
obtain early input from both FDA and private payers, and plan
accordingly. The communications within the scope of this notice consist
of input from coverage organizations to sponsors on clinical trial
design or other

plans for gathering clinical evidence needed to support positive
coverage decisions. It is not intended to include sponsors'
communications of clinical evidence to coverage organizations. These
coverage organizations include third-party commercial health insurance
organizations, payer/provider organizations, health technology
assessment groups and various other organizations that evaluate
clinical evidence and make coverage recommendations to and decisions
for private payers and health plans.
    Timely access to innovative medical devices has been a significant
issue in the delivery of high quality health care. Generally, access to
medical devices first requires FDA approval or clearance for marketing,
and, for broad patient access to innovative devices, coverage by
payers. In this context, a ``payer'' refers to those organizations that
may provide both coverage and reimbursement for the use of a medical
device within a variety of clinical settings. They are generally third-
party commercial health insurance companies, health plans, payer-
provider organizations, and others.
    Without proper planning, medical device sponsors developing
innovating devices might encounter delays or barriers to payer
coverage. Development of medical devices often occurs in a sequential
manner, whereby the sponsor initially interacts with FDA to determine
whether or not clinical evidence would be required in a subsequent
marketing application for FDA approval or clearance. If clinical data
are required, the sponsor may further interact with FDA to develop the
study protocol for the pivotal clinical trial. Next, the sponsor
initiates and conducts the clinical trial and then submits that
clinical evidence to FDA in a premarket submission. Lastly, the FDA
reviews the submission and issues a regulatory decision. It is after
these steps have been completed that the sponsor may begin marketing
the device; however, the clinical evidence sufficient for marketing the
device is not always the same as that needed to support payer coverage
decisions.
    Payer evidentiary requirements for coverage depend on the payer. In
some cases, payers may make their own independent coverage decisions.
In other cases, payers may rely on Health Technology Assessments (HTAs)
conducted by others, including CMS.
    While some clinical evidence developed in a pivotal clinical trial
undertaken to support FDA approval or clearance could support payer
coverage decisions, outcome endpoints needed by payers, such as
comparison to other therapies and the associated costs of those
therapies, are often not fully collected. If the sponsor subsequently
learns that these data are needed for coverage determinations, even if
the data exist, it may be difficult to collect and analyze
retrospectively, years after the pivotal clinical study was initiated.
It is similarly challenging to conduct an additional clinical trial
after FDA approval or clearance designed only to meet a payer's needs.
Either situation can result in delays to coverage and broad patient
access, with negative implications for the public health.
    Further, it may be difficult for sponsors to identify and engage
with coverage organizations, and as a result, sponsors may not consider
the evidentiary needs of coverage organizations when planning their
pivotal clinical study.
    If coverage organizations express interest, CDRH intends to create
a mechanism for such organizations to identify themselves so medical
device sponsors who would like to obtain coverage input can voluntarily
contact them to participate in an FDA Pre-Submission meeting. CDRH
intends to list interested coverage organizations on its Web site.
Sponsors who voluntarily meet with coverage organizations early in the
device development process may obtain the information to initially
design a clinical trial that can capture both the data necessary for
FDA marketing clearance or approval and that necessary to support a
positive payer coverage decision, to modify their pivotal study to
satisfy both sets of requirements, or to develop other plans to collect
the necessary data. This may help avoid delays to patient access that
may result if clinical trials are conducted, or data are collected,
sequentially when it could have been done concurrently.
    Sponsors are not required to include a coverage organization in any
Pre-Submission meeting. Coverage organizations are not required to
submit expressions of interest in order to be included in a Pre-
Submission meeting. The regulatory and evidentiary standards FDA uses
for decisionmaking would not change; under any review scenario, FDA
would continue to make its decisions under its authority and with its
own standards, independent of the coverage organization's input.

II. Expression of Interest by Coverage Organizations

    CDRH's Pre-Submission program, by providing a forum to support
communication with sponsors prior to the finalization of their clinical
trial design, serves as a potential tool to facilitate sponsor
communication with coverage organizations that make private coverage
determinations in a manner that would promote the public health (Ref.
1). FDA is requesting that organizations that evaluate clinical
evidence used to support private payer decisions for medical devices,
and that may be interested in communicating to device sponsors about
the evidence needed to support positive coverage determinations, send
an email to<EMAIL_ADDRESS>to express interest. The
subject line of the email should state: ``Expression of Interest in
Providing Input Regarding Private Payer Coverage to Medical Device
Sponsors.'' The body of the email should contain the organization's
name, email, and mailing address. If necessary, we may follow up with
organizations that respond solely to clarify their identifying
information.
    Additional information may also be posted on the CDRH Payer
Communication Task Force Web site. For general questions or concerns,
contact CDRH Innovation at the email listed in the FOR FURTHER
INFORMATION CONTACT section of this document.

III. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has
verified the Web site address, but we are not responsible for any
subsequent changes to the Web site address after this document
publishes in the Federal Register.)
    1. FDA Guidance, ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff.'' Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.

    Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03909 Filed 2-23-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26019-26020]
[FR Doc No: 2021-10008]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC21-23-000]

Commission Information Collection Activities (FERC-725V); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-725V, Mandatory Reliability Standards: COM
Reliability Standards.

DATES: Comments on the collection of information are due July 12, 2021.

ADDRESSES: You may submit copies of your comments (identified by Docket
No. IC21-23-000) by one of the following methods:
    Electronic filing through http://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery:
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Hand (including courier) Delivery: Deliver to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov. For user
assistance, contact FERC Online Support by email at
<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725V, Mandatory Reliability Standards: COM Reliability
Standards.
    OMB Control No.: 1902-0277.
    Type of Request: Three-year extension of the FERC-725V information
collection requirements with no changes to the reporting requirements.
    Abstract: On August 15, 2016, the North American Electric
Reliability Corporation (NERC) filed a petition for Commission
approval, pursuant to section 215(d)(1) of the Federal Power Act
(``FPA'') \1\ and Section 39.5 \2\ of the Federal Energy Regulatory
Commission's regulations, for Reliability Standard COM-001-3
(Communications), the associated Implementation Plan, retirement of
currently-effective Reliability Standard COM-001-2.1, and Violation
Risk Factors (``VRFs'') and Violation Severity Levels (``VSLs'')
associated with new Requirements R12 and R13 in Reliability Standard
COM-001-3. Reliability Standard COM-001-3 reflects revisions developed
under Project 2015-07 Internal Communications Capabilities, in
compliance with the Commission's directive in Order No. 888 that NERC
``develop modifications to COM-001-2, or develop a new standard, to
address the Commission's concerns regarding ensuring the adequacy of
internal communications capability whenever internal communications
could directly affect the reliability opera.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824o (2012).
    \2\ 18 CFR 39.5 (2015).
---------------------------------------------------------------------------

    Reliability Standards COM-001-3 and COM-002-4 do not require
responsible entities to file information with the Commission. COM-001-3
requires that transmission operators, balancing authorities,
reliability coordinators, distribution providers, and generator
operators must maintain documentation of Interpersonal Communication
capability and designation of Alternate Interpersonal Communication, as
well as evidence of testing of the Alternate Interpersonal
Communication facilities. COM-002-4 requires balancing authorities,
distribution providers, reliability coordinators, transmission
operators, and generator operators to develop and maintain documented
communication protocols, and to be able to provide evidence of training
on the protocols and of their annual assessment of the protocols.
Additionally, all applicable entities (balancing authorities,
reliability coordinators, transmission operators, generator operators,
and distribution providers) must be able to provide evidence of three-
part communication when issuing or receiving an Operating Instruction
during an Emergency.
    Type of Respondents: Public utilities.
    Estimate of Annual Burden: \3\ The Commission estimates the annual
public reporting burden for the information collection as:
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    \3\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.

                                          FERC-725V--Mandatory Reliability Standards: COM Reliability Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Annual  number
                                         Number of        of  responses   Total number    Average burden and    Total annual  burden hours     Cost per
                                        respondents            per        of responses    cost per response 4   and  total annual cost  ($)   respondent
                                                           respondent                                                                            ($)
                                   (1).................             (2)     (1) * (2) =  (4).................  (3) * (4) = (5).............    (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
(On-going) Maintain evidence of    1,313 (BA, DP, GOP,                1           1,313  4 hrs.; $228........  5,252 hrs.; $299,364........         $228
 Interpersonal Communication        RC & TOP).
 capability 5.
(On-going) Maintain evidence of    199 (BA, RC & TOP)..               1             199  8 hrs.; 456.........  1,592 hrs.; 90,744..........          456
 training and assessments 6.
(On-going) Maintain evidence of    1,257 (DP & GOP)....               1           1,257  8 hrs.; 456.........  10,056 hrs.; 573,192........          456
 training 7.
                                                        ------------------------------------------------------------------------------------------------
    Total........................  ....................  ..............           2,769  ....................  16,900 hrs.; 963,300........  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
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    \4\ The estimates for cost per response are loaded hourly wage
figure (includes benefits) is based on two occupational categories
for 2020 found on the Bureau of Labor Statistics website (http://www.bls.gov/oes/current/naics2_22.htm): The hourly estimates for
salary plus benefits are: (a) Electrical Engineer (code 17-2071),
$70.19; (b) Information and Record Clerk (code 43-4199), $43.38. The
average hourly cost (salary plus benefits), weighting both skill
sets equally, is $56.79. For these calculations, we round the figure
to $57.00 per hour.
    \5\ For COM-001-3 the BA, RC, TOP, GOP, DP were taken as
aggregate to eliminate overlap if the same entity has multiple
registrations.
    \6\ For COM-002-4 the BA, RC and TOP were taken as aggregate to
eliminate overlap if the same entity has multiple registration.
    \7\ For COM-002-4 the DP and GOP were taken as aggregate to
eliminate overlap if the same entity has multiple registrations.

    Dated: May 6, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-10008 Filed 5-11-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 18, 2007 (Volume 72, Number 11)]
[Notices]
[Page 2324-2325]
[DOCID:fr18ja07-120]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55080; File No. SR-Phlx-2006-51]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Order Granting Approval to Proposed Rule Change Relating to Performance
Evaluations for Streaming Quote Traders and Remote Streaming Quote
Traders

January 10, 2007.

I. Introduction

    On November 22, 2006, the Philadelphia Stock Exchange, Inc.
(``Phlx'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt Phlx Rule 510, SQT and
RSQT Performance Evaluation, to establish performance requirements for
Streaming Quote Traders (``SQTs'') \3\ and Remote Streaming Quote
Traders (``RSQTs'').\4\ The proposed rule change was published for
comment in the Federal Register on December 11, 2006.\5\ The Commission
received no comments regarding the proposal. This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Phlx Rule 1014(b)(ii)(A).
    \4\ See Phlx Rule 1014(b)(ii)(B).
    \5\ See Securities Exchange Act Release No. 54859 (December 1,
2006), 71 FR 71605.
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II. Description of the Proposal

    The purpose of the proposed rule change is to adopt new Phlx Rule
510 to: (1) Establish performance requirements for SQTs and RSQTs; (2)
authorize the Exchange to conduct performance evaluations periodically;
and (3) authorize the Exchange's Options Allocation, Evaluation and
Securities Committee (``OAESC'') \6\ to take corrective action where
minimum requirements are not met.
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    \6\ See Phlx By-Law Article X, Section 10-7.
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    Proposed Phlx Rule 510 would provide for monthly performance
evaluations of SQTs and RSQTs to determine whether they have fulfilled
performance standards relating to, among other things, quality of
markets, efficient quote submission to the Exchange (including quotes
submitted through a third party vendor), competition, observance of
ethical standards, and administrative factors.
    The proposal would permit the Exchange to consider requests for
relief from established quote spread

parameters on the Exchange \7\ and efficiency of quote submission
through the Specialized Quote Feed (``SQF''), as defined in Phlx Rule
1080, Commentary .01. Failure to meet established minimum performance
requirements could result in restriction by the OAESC of additional
options assignments; suspension, termination, or restriction of an
existing assignment on one or more options; or suspension, termination,
or restriction of an SQT's or RSQT's status as such.
---------------------------------------------------------------------------

    \7\ See Phlx Rule 1014(c)(i)(A).
---------------------------------------------------------------------------

    Phlx Rule 510 would establish specific criteria for each option
assigned to an SQT or RSQT that would be regularly evaluated by the
Exchange. First, the Exchange would evaluate the percentage of total
quotes submitted by the SQT or RSQT that represent the NBBO. If the
percentage of the total quotes that represent the NBBO is in the lowest
quartile of all SQTs or RSQTs for two or more consecutive months, this
may be considered sub-standard performance. Second, the Exchange would
evaluate the SQT or RSQT's adherence to the Exchange's established
quoting requirements pursuant to Phlx Rule 1014.\8\ If an SQT or RSQT
fails to meet the quoting requirements as prescribed by the rule, this
may be considered sub-standard performance. Third, the Exchange would
consider the number of requests for quote spread parameter \9\ relief
for the purposes of evaluating performance standards.
---------------------------------------------------------------------------

    \8\ Phlx Rule 1014(b)(ii)(D)(1) provides that an SQT and an RSQT
shall be responsible to quote continuous, two-sided markets in not
less than 60% of the series in each option in which such SQT or RSQT
is assigned, provided that, on any given day, a Directed SQT
(``DSQT'') or a Directed RSQT (``DRSQT'') (as defined in Phlx Rule
1080(l)(i)(C)) shall be responsible to quote continuous, two-sided
markets in not less than 99% of the series listed on the Exchange in
at least 60% of the options in which such DSQT or DRSQT is assigned.
Whenever a DSQT or DRSQT enters a quotation in an option in which
such DSQT or DRSQT is assigned, such DSQT or DRSQT must maintain
continuous quotations for not less than 99% of the series of the
option listed on the Exchange until the close of that trading day.
    \9\ Phlx Rule 1034 establishes maximum allowable bid/ask
differentials on the Exchange.
---------------------------------------------------------------------------

    Finally, to evaluate efficient quote submission to the Exchange,
the Exchange would consider how an SQT or RSQT optimizes the submission
of quotes through the SQF, as defined in Phlx Rule 1080, by evaluating
the number of individual quotes per quote ``block'' received by the
Exchange.\10\ An SQT or RSQT is assigned a number of ports or lines on
which they can send quote blocks. The number of lines assigned dictates
the number of blocks that may be sent simultaneously by the SQT or
RSQT. The number of lines assigned to an SQT or RSQT is generally a
function of the number of products being quoted, taking into account
the throughput required to minimize quote latency risk. The Exchange
intends to evaluate the average number of quotes (1-99) submitted
within the SQT or RSQT's quote blocks. The number of quotes delivered
in each block would generally be a measure of the SQT or RSQT's quoting
efficiency. For example, a firm sending an average of 1 quote in each
block may be considered inefficient while a firm sending an average of
99 quotes in each block would be considered very efficient.
---------------------------------------------------------------------------

    \10\ A quote ``block'' is a component of the Exhange's SQF
application that allows for delivery of a set of multiple quotations
from the SQT or RSQT to the Exchange. Within a single ``block,'' the
SQT or RSQT can deliver quotes for any number of option series
ranging from 1 to 99.
---------------------------------------------------------------------------

    The Exchange explained that, in general, the expenditure of
systemic resources required to process an inefficient block is nearly
equal to the expenditure of systemic resources required to process an
efficient block. Therefore, an efficient SQT or RSQT can achieve a much
higher level of quote submission than an inefficient SQT or RSQT using
nearly the same amount of exchange system resources. The Exchange
believes that the regular monitoring of quoting efficiency in this
fashion will result in more efficient quoting on the Exchange (i.e.,
more quotes submitted per block), thus preserving and maximizing
Exchange system capacity for handling quote traffic.

III. Discussion

    After careful review of the proposal, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\11\ In particular, the Commission finds that the
proposal is consistent with Section 6(b)(5) of the Act,\12\ which
requires, among other things, that the rules of an exchange be designed
to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \11\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the Exchange's proposal to establish
performance requirements for SQTs and RSQTs should, among other things,
encourage Exchange traders to enhance quoting efficiency, preserve
system capacity, and minimize requests for relief from quote spread
parameters. Consequently, the proposal should encourage Phlx SQTs and
RSQTs to strive to improve their performance as market makers on the
Exchange, as well as help to mitigate the Exchange's quote message
traffic.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\13\ that the proposed rule change (SR-Phlx-2006-51), be, and
hereby is, approved.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-586 Filed 1-17-07; 8:45 am]

BILLING CODE 8011-01-P


P-20-0161 Sanitized Support Documents Index:
 P-20-0161 Sanitized Determination Document (linked)
 P-20-0161 Sanitized CHEM Report (attached)
 P-20-0161 Sanitized ECO Report (attached)
 P-20-0161 Sanitized ENG Report (attached)
 P-20-0161 Sanitized EXP Report (attached)
 P-20-0161 Sanitized Fate Report (attached)
 P-20-0161 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30737-30738]
[FR Doc No: 2011-13034]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1976-DR; Docket ID FEMA-2011-0001]

Kentucky; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-1976-DR), dated May 4, 2011, and
related determinations.

DATES: Effective Date: May 17, 2011.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the

Commonwealth of Kentucky is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of May 4, 2011.

    Butler, Caldwell, Calloway, Edmonson, Elliott, Graves, Logan,
Lyon, Monroe, Todd, and Trigg Counties for Public Assistance,
including direct Federal Assistance.
    Fulton, and Union Counties for Public Assistance (already
designated for emergency protective measures [Category B], limited
to direct Federal assistance, under the Public Assistance program).

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-13034 Filed 5-25-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)]
[Notices]
[Page 370]
[FR Doc No: 2017-28326]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP18-271-000]

Peregrine Oil & Gas II, LLC v. Texas Eastern Transmission, LP;
Notice of Amended and Restated Complaint

    Take notice that on December 19, 2017, pursuant to sections 5 and
16 of the Natural Gas Act, 15 U.S.C. 717d and 717o, and Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206, Peregrine Oil & Gas II, LLC
(Complainant), filed an amended and restated complaint to update its
original complaint filed on June 1, 2017 against Texas Eastern
Transmission, LP (Respondent or Texas Eastern), alleging that
Respondent has violated (1) its service obligations under its tariff,
section 4 of the NGA, and Commission regulations by failing to exercise
due diligence to remedy two recent outages on its FERC-certificated
Line 41-A System and to remove the cause of such outages in an adequate
manner and with all reasonable dispatch; (2) section 4 of the NGA and
Commission regulations by requiring that, as a condition to repairing
its Line 41-A System and restoring service thereon, producers pay
extra, un-tariffed charges to Texas Eastern, ostensibly to reimburse it
for the claimed costs of, among other things, the maintenance work; and
(3) section 7 of the NGA by abandoning its Line 41-A System facilities
without Commission authorization, all as more fully explained in the
amended and restated complaint.
    Complainant certifies that a copy of the complaint has been served
on the Respondent and the Presiding Administrative Law Judge.
    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, 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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    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 5 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 electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on January 8, 2018.

    Dated: December 22, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-28326 Filed 1-2-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 210 (Thursday, October 30, 2014)]
[Notices]
[Page 64587]
[FR Doc No: 2014-25831]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER12-1436-007; ER14-152-002; ER13-1793-004; ER12-
1260-006; ER10-3099-009; ER10-2329-004.
    Applicants: Eagle Point Power Generation LLC, Elgin Energy Center,
LLC, Hazle Spindle, LLC, RC Cape May Holdings, LLC, Stephentown
Spindle, LLC, Vineland Energy LLC.
    Description: Supplement to June 23, 2014 Triennial Market-Based
Rate Update Filing for the Northeast Region and Notice of Non-Material
Change in Status of the Rockland Seller.
    Filed Date: 10/14/14.
    Accession Number: 20141014-5173.
    Comments Due: 5 p.m. ET 11/4/14.

    Docket Numbers: ER15-175-000.
    Applicants: San Diego Gas & Electric Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2015
SDGE RS Update to Transmission Owner Tariff to be effective 1/1/2015.
    Filed Date: 10/23/14.
    Accession Number: 20141023-5141.
    Comments Due: 5 p.m. ET 11/13/14.

    Docket Numbers: ER15-176-000.
    Applicants: Wheeling Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Reactive Supply and Voltage Control from Generation Sources Concurrence
to be effective 12/31/2014.
    Filed Date: 10/23/14.
    Accession Number: 20141023-5149.
    Comments Due: 5 p.m. ET 11/13/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 23, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-25831 Filed 10-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Rules and Regulations]
[Pages 59646-59648]
[FR Doc No: 2021-23350]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0524; FRL-8762-02-R4]

Air Plan Approval; South Carolina; 2018 General Assembly New
Source Review Update

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing
approval of State Implementation Plan (SIP) revisions submitted by the
State of South Carolina, through the South Carolina Department of
Health and Environmental Control (SCDHEC or Department), on April 24,
2020. The SIP revisions update the State's Prevention of Significant
Deterioration (PSD) and Nonattainment New Source Review (NNSR)
regulations. Specifically, the SIP revisions add and update several
definitions for consistency with the Federal regulations, update public
participation requirements for PSD, clarify the applicability of
``source impact analysis'' for PSD, add an emissions offset banking
provision for NNSR, and make administrative updates, such as
typographical corrections and renumbering. Finally, the changes
incorporate language that addresses the public notice rule provisions
for NNSR, which removes the mandatory requirements to provide public
notice in a newspaper and instead allows for electronic notice (``e-
notice'') as an alternate noticing option for the State. EPA is
approving these revisions pursuant to the Clean Air Act (CAA or Act)
and implementing Federal regulations.

DATES: This rule is effective November 29, 2021.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2020-0524. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Andres Febres, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8966. Mr. Febres can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On April 24, 2020, SDHEC submitted SIP revisions to EPA for
approval that include changes to South Carolina's major source New
Source Review (NSR) permitting regulations to make them more closely
align with Federal requirements for PSD and NNSR permitting; correct
typographical errors; and update internal references, including
renumbering throughout both regulations. Specifically, these changes
update South Carolina Regulation 61-62.5, Standard No. 7--Prevention of
Significant Deterioration and Standard No. 7.1--Nonattainment New
Source Review.\1\ Additionally, the SIP revisions include an update to
the public noticing procedures for South Carolina's NNSR regulations to
address changes promulgated in the Federal rule entitled ``Revisions to
Public Notice Provisions in Clean Air Act Permitting Programs,'' (also
referred to as the e-Notice Rule) that was finalized in 2016. See 81 FR
71613 (October 18, 2016).\2\
---------------------------------------------------------------------------

    \1\ On April 24, 2020, SDHEC also submitted to EPA SIP revisions
to Regulations 61-62.1, Section I--Definitions; 61-62.1, Section
II--Permit Requirements; 61-62.1, Section III--Emission Inventory
and Emissions Statement; 61-62.1, Section IV--Source Tests; 61-62.1,
Section V--Credible Emissions; 61-62.5, Standard No. 2--Ambient Air
Quality Standards; and 61-62.5, Standard 5.2--Control of Oxides of
Nitrogen (NOX). EPA will address these SIP revisions in separate
actions.
    \2\ EPA previously approved e-notice provisions for South
Carolina's PSD program. See 83 FR 64285 (December 14, 2018).
Although the e-notice provisions in the State's NNSR program are
being incorporated into the SIP for the first time, the April 24,
2020, SIP revisions also include updates to the already SIP-approved
e-notice provisions in South Carolina's SIP-approved PSD program.
---------------------------------------------------------------------------

    On July 29, 2021, EPA published a notice of proposed rulemaking
(NPRM), proposing to approve with some exceptions, the changes
submitted by South Carolina on April 24, 2020. \3\ See 86 FR 40796.
Comments on the NPRM were due by August 30, 2021. EPA received only one
comment on the NPRM, which was in favor of EPA's action. The one
comment received can be found in the docket for this action.
---------------------------------------------------------------------------

    \3\ For more details on the exemptions to EPA's approval, see
the NPRM for this action.
---------------------------------------------------------------------------

II. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of South
Carolina's Regulation 61-62.5, Standards No. 7--Prevention of
Significant Deterioration, and Standard No. 7.1--Nonattainment New
Source Review, both state effective on April 24, 2020, with the
exception of paragraph (H), and a portion of paragraphs (A)(10)(t), and
(B)(22)(c)(xx), from Regulation 61-62.5, Standard No. 7.1, as discussed
in the NPRM.\4\ EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and at the
EPA Region 4 Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the State implementation plan, have been incorporated by
reference by EPA into that plan, are fully federally enforceable under
sections 110 and 113 of the CAA as of the effective date of the final
rulemaking of EPA's approval, and will be incorporated by reference in
the next update to the SIP compilation.\5\
---------------------------------------------------------------------------

    \4\ See 86 FR 40796 at 40798.
    \5\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

III. Final Action

    As described in more detail in the NPRM, EPA is approving, with
some exceptions, the changes to the South Carolina Regulation 61-62.5,
Standards No. 7--Prevention of Significant Deterioration, and Standard
No. 7.1--Nonattainment New Source Review, as submitted by South
Carolina on April 24, 2020.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    Because this final rule merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law, this final rule for the State of South
Carolina does not have Tribal implications as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000). Therefore, this action
will not impose substantial direct costs on Tribal governments or
preempt Tribal law. The Catawba Indian Nation (CIN) Reservation is
located within the boundary of York County, South Carolina. Pursuant to
the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120
(Settlement Act), ``all state and local environmental laws and
regulations apply to the [Catawba Indian Nation] and Reservation and
are fully enforceable by all relevant state and local agencies and
authorities.'' The CIN also retains authority to impose regulations
applying higher environmental standards to the Reservation than those
imposed by state law or local governing bodies, in accordance with the
Settlement Act.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 27, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

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

    Dated: October 21, 2021.
John Blevins,
Acting Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart PP--South Carolina

0
2. Section 52.2120(c) is amended by revising the entries for ``Standard
No. 7'' and ``Standard No. 7.1'' to read as follows:

Sec.  52.2120  Identification of plan.

* * * * *
    (c) * * *

                                     EPA-Approved South Carolina Regulations
----------------------------------------------------------------------------------------------------------------
                                                          State
         State citation             Title/subject    effective date   EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Standard No. 7.................  Prevention of            4/24/2020  10/28/2021,         .......................
                                  Significant                         [Insert citation
                                  Deterioration.                      of publication].
Standard No. 7.1...............  Nonattainment New        4/24/2020  10/28/2021,         Except for paragraph
                                  Source Review.                      [Insert citation    (H) and the ethanol
                                                                      of publication].    production facilities
                                                                                exclusion in
                                                                                paragraphs (A)(10)(t)
                                                                                and (B)(22)(c)(xx).

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

* * * * *

[FR Doc. 2021-23350 Filed 10-27-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Notices]
[Pages 53822-53824]
[FR Doc No: 2019-21964]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2018-0027; Notice No. 2018-09]

Hazardous Materials: Clarification of Process To Reissue
Explosives Classification Approvals

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments.

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

SUMMARY: PHMSA issues this notice to clarify and request comments on
the Approvals Program procedures for companies to request a
modification to an explosives classification approval to reflect a
merger, acquisition, or change in name or legal status.

DATES: Interested persons are invited to submit comments on or before
January 6, 2020.

ADDRESSES: You may submit comments identified by Docket No. PHMSA-2018-
0027 via any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, Routing
Symbol M-30, 1200 New Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: To Docket Operations, Room W12-140 on the
ground floor of the West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Instructions: All submissions must include the agency name and
docket number for this notice. Internet users may access comments
received by the DOT at: http://www.regulations.gov. Please note that
comments received will be posted without change to: http://www.regulations.gov including any personal information provided.
    Privacy Act: In accordance with 5 U.S.C. 553(c), the DOT solicits
comments from the public. The DOT posts these comments, without edit,
including any personal information the commenter provides, to http://www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Pipeline and Hazardous Materials
Safety Administration: Laura Ulmer, Attorney-Advisor (PHC-10), U.S.
Department of Transportation, Pipeline and Hazardous Materials Safety
Administration, 1200 New Jersey Avenue SE, East Building, 2nd Floor,
Washington, DC 20590-0001, Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    As defined in title 49, section 173.56 of the Code of Federal
Regulations (CFR), a ``new explosive'' is an explosive produced by a
person who either has not previously produced that explosive, or has
previously produced that explosive, but has made a change in the
formulation, design, or process so as to alter any of the properties of
the

explosive. The Hazardous Materials Regulations (HMR; 49 CFR parts 171-
180) require that each new explosive be examined by a DOT-approved
explosives test laboratory and assigned a recommended shipping
description, division, and compatibility group in accordance with Sec.
173.56(b). This classification must be approved by PHMSA. Applications
are submitted and approvals are issued per the requirements in 49 CFR
part 107, subpart H. These explosive classification approvals are
generally known as ``EX'' approvals. A ``person,'' as defined in 49 CFR
171.8, must obtain an approval classifying each new explosive that he
or she offers or transports to, from, or within the United States. In
December 2015, PHMSA posted a document titled ``EXPLOSIVES
CLASSIFICATION (EX) APPROVALS (Company Name Changes, Mergers,
Acquisitions, and Changes in Legal Structure)'' on its website, http://www.phmsa.dot.gov. This document clarified that: (1) An EX approval is
non-transferable in any merger, acquisition, sale of assets, or other
business transaction; (2) an EX approval is non-transferrable in
bankruptcy proceedings, and thus, a debtor may not use an EX approval
as an asset to sell in order to drive up the purchase price; and (3)
PHMSA may reissue the EX approvals in certain situations to reflect the
new company name, when adequate documentation is submitted. The
document also included frequently asked questions on several common
merger, acquisition, and legal-status change scenarios and provided
instructions on how companies could request a modification of an EX
approval to reflect a status change. Companies can also choose to apply
for new EX approvals instead of requesting to go through the company
name-change process.
    The specific scenarios and documentation requirements included in
the document led to questions and concerns from the regulated
community. Therefore, we are clarifying the description of the program
procedures and documentation required for PHMSA to reissue EX
approvals. Specifically, we have revised the guidance to remove the
requirement that the applicant declare that the information that it is
providing for the certification is correct, under penalty of perjury,
after certain members of the regulated community had concerns about
swearing under penalty of perjury that documents they did not
personally draw up were complete and correct. PHMSA acknowledges those
concerns, and believes that the modification of the certification
letter contents will alleviate these concerns. The guidance also
clarifies that companies which request a modification at least 30 days
prior to the merger, acquisition, or legal-status change can continue
to use their existing approvals until PHMSA takes final administrative
action on the application for modification. PHMSA is seeking comments
on:
    1. The contents of the certification letter;
    2. the description of the timeline for applying and processing a
name change; and
    3. information requested for additional facilities.

II. Clarification of Requirements To Reissue Approvals

    Companies always have the option to apply for a new EX approval in
anticipation of a merger, acquisition, or other change in corporate
structure or form. Alternatively, PHMSA may reissue existing EX
approvals when adequate documentation is provided for the types of
corporate changes described in this guidance. Provided a request to
reissue an EX approval is made at least 30 days prior to the
anticipated corporate change, the new entity may continue to use the
existing EX approval until PHMSA reaches a final decision on the
request. Title 49 CFR part 107, subpart H and Sec.  173.56(b) set out
the requirements for applying for an EX approval. Table 1, below,
explains what is meant by various types of requested documents. Table
2, which follows, explains which of these documents are requested for
an EX approval to be reissued in different scenarios.

                     Table 1--Types of Documentation
------------------------------------------------------------------------

------------------------------------------------------------------------
Certification Letter....................  When applicable, the company
                                           requesting the reissued
                                           approval will submit a
                                           certification letter that:
                                             A. Is signed by a director
                                              or officer of the company
                                              requesting the reissued
                                              approval;
                                             B. states that the company
                                              is not producing a new
                                              explosive and that there
                                              has been no change in the
                                              formulation, design, or
                                              process so as to alter any
                                              of the properties of the
                                              explosive; and
                                             C. states that the
                                              requesting company
                                              understands that failure
                                              to provide accurate and
                                              complete information could
                                              result in the
                                              modification, suspension,
                                              or termination of the
                                              approval.
Approvals List..........................  A list of EX approval numbers
                                           and product descriptions, and
                                           a copy of each EX approval
                                           that the company is
                                           requesting that PHMSA
                                           reissue.
Lab Report..............................  Copies of any laboratory
                                           reports or technical drawings
                                           in the company's possession
                                           relating to the requested EX
                                           approvals.
Proof of Change.........................  Legal documentation of the
                                           applicable change (e.g.,
                                           certification of merger,
                                           sales agreement, etc.).
Relinquishment Letter...................  When applicable, the company
                                           that initially held the
                                           approval should provide a
                                           letter that:
                                             A. Is signed by a director
                                              or officer of the company
                                              holding the initial
                                              approval; and
                                             B. states that the company
                                              holding the initial
                                              approval voluntarily
                                              relinquishes all the
                                              rights to the EX approval
                                              numbers listed in the
                                              document and that they
                                              will no longer manufacture
                                              the explosives approved
                                              under those respective EX
                                              approvals.
------------------------------------------------------------------------

                                      Table 2--Requested Documentation To Reissue Approvals in Different Scenarios
--------------------------------------------------------------------------------------------------------------------------------------------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Scenario                              Documents requested to reissue EX approval
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Cert.               EX                 Lab                Proof              Relinquishment
                                                     letter............  number list......  reports..........  of change........  letter
--------------------------------------------------------------------------------------------------------------------------------------------------------
Merger.........................  Hazmat Companies    Yes...............  Yes..............  Yes..............  Yes (merger        No.
                                  A, B, C, and D                                                                certification).
                                  are merging to
                                  create new
                                  company X, which
                                  is legally
                                  distinct from its
                                  predecessors.
                                  Company X wants
                                  to perform
                                  activities that
                                  require an EX
                                  approval.

Total Purchase.................  Company A buys      Yes...............  Yes..............  Yes..............  Yes (sales         No.
                                  100% of Company                                                               agreement).
                                  B. Both companies
                                  hold EX
                                  approvals.
                                  Company B will
                                  now operate under
                                  Company A's name.
                                  Company A wants
                                  to use Company
                                  B's EX approvals.
Partial Purchase (Assets)......  Company A buys      Yes...............  Yes..............  Yes..............  Yes (sales         Yes.
                                  less than 100% of                                                             agreement).
                                  Company B's
                                  assets. Company A
                                  wants to use
                                  Company B's EX
                                  approvals.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subsidiary (Separate Legal       X Corporation has   N/A. Reissuing of EX numbers is not permitted. Each of the four companies (one parent and three
 Entities).                       three               subsidiaries) needs EX approvals for covered activities. Each of these entities is a separate
                                  subsidiaries that   ``person'' based on the definition PHMSA uses. The term ``person'' refers to each separate legal
                                  are distinct        entity, such as a corporation, partnership, association, or LLC, or LP. This means that a
                                  legal entities:     separately incorporated subsidiary (or LLC or LP) must apply for their own approval if it engages
                                  X LLC,...   in activities that require an EX approval, even when a parent company already holds an EX
                                  X Inc.,     approval.
                                  and.
                                  X LP.....
                                 X Corporation
                                  wants to use X
                                  Inc.'s EX
                                  approvals..
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Additional, U.S. Facility..  Company X adds a    N/A. No change needed.
                                  new U.S.
                                  facility. The
                                  principal place
                                  of business and
                                  manufacturing
                                  process do not
                                  change.
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Primary, U.S. Facility.....  Company X changes   No................  Yes..............  Yes..............  No...............  No.
                                  ``principal place
                                  of business'' to
                                  new U.S.
                                  facility, and
                                  therefore must
                                  submit an
                                  application to
                                  amend its EX
                                  approval.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additional Facility Abroad.....  Company X           N/A. All manufacturing locations outside of the U.S. are required to apply for their own EX
                                  purchases an        approvals.
                                  additional
                                  manufacturing
                                  plant location
                                  outside of the
                                  United States.
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Name, Same Legal Structure.  Company X changes   No................  Yes..............  Yes..............  No...............  No.
                                  its name to
                                  ``Company Y,''
                                  but does not
                                  change the legal
                                  structure or
                                  ownership of the
                                  company.
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Name, New Legal Structure..  Company X, LLC      Yes...............  Yes..............  Yes..............  No...............  No.
                                  changes its name
                                  to ``Company X,
                                  Inc.'' indicating
                                  a change in legal
                                  structure.
                                  Company X., Inc.
                                  wants to use
                                  Company X, LLC's
                                  approval.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bankruptcy.....................  Debtor holds an EX  N/A. EX approvals are non-transferrable and cannot be treated as assets in the event of a
                                  approval with       bankruptcy.
                                  PHMSA and goes
                                  into bankruptcy.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Signed in Washington, DC, on October 2, 2019.
William S. Schoonover,
Associate Administrator for Hazardous Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2019-21964 Filed 10-7-19; 8:45 am]
BILLING CODE 4909-60-P


[Federal Register: November 9, 2007 (Volume 72, Number 217)]
[Proposed Rules]
[Page 63510-63512]
[DOCID:fr09no07-21]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2006-23742; Directorate Identifier 2005-NE-53-AD]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney (PW) JT9D-7R4 Series
Turbofan Engines

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

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede an existing airworthiness
directive (AD) for PW JT9D-7R4 series turbofan engines. That AD
currently requires removing certain reduced cooling flow 2nd stage high
pressure turbine (HPT) vane assemblies installed in certain 2nd stage
HPT vane cluster assemblies. It also requires a visual and a
fluorescent penetrant inspection (FPI) of the 2nd stage HPT air seal
assembly, P/N 815097. This proposed AD would require a visual and
fluorescent penetrant inspection (FPI) of all part number (P/N) 2nd
stage HPT air seal assemblies that were used with reduced cooling flow
2nd stage HPT vane assemblies. This proposed AD results from the
manufacturer identifying additional P/N air seal assemblies that are
affected by the unsafe condition. We are proposing this AD to prevent
uncontained failure of the 2nd stage HPT air seal assembly, leading to
engine in-flight shutdown and damage to the airplane.

DATES: We must receive any comments on this proposed AD by January 8,
2008.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD.
     Federal eRulemaking Portal: Go to http://www.regulations.gov
 and follow the instructions for sending your

comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Contact Pratt & Whitney, 400 Main St., East Hartford, CT 06108;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for the service
information identified in this proposed AD.

FOR FURTHER INFORMATION CONTACT: Mark Riley, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments regarding this proposal. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2006-23742;
Directorate Identifier 2005-NE-53-AD'' in the subject line of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the proposed AD. We will
consider all comments received by the closing date and may amend the
proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

Discussion

    The FAA proposes to amend 14 CFR part 39 by superseding AD 2007-17-
21, Amendment 39-15180 (72 FR 48549, August 24, 2007). That AD requires
removing reduced cooling flow 2nd stage HPT vane assemblies. It also
requires a visual and an FPI of the 2nd stage HPT air seal assembly.
That AD resulted from a report of an uncontained failure of the 2nd
stage HPT air seal assembly, caused by the air seal assembly brace
disengaging from the air seal, due to insufficient cooling air flow.
That condition, if not corrected, could result in uncontained failure
of the 2nd stage HPT air seal assembly, leading to engine in-flight
shutdown and damage to the airplane.

Actions Since AD 2007-17-21 Was Issued

    Since we issued that AD, we determined that we need to expand the
applicability of the AD to include all 2nd stage HPT air seal
assemblies that were used with reduced cooling flow 2nd stage HPT vane
assemblies, P/Ns 797282, 796972, 800082, 800072, 803182, 803282, and
822582, installed in 2nd stage HPT vane cluster assemblies P/Ns 797592,
797372, 799872, 799782, and 822572.

Relevant Service Information

    We have reviewed and approved the technical contents of Pratt &
Whitney Alert Service Bulletin JT9D-7R4-A72-596, dated September 15,
2005, that describes procedures for modifying the reduced cooling flow
2nd stage HPT vane assemblies.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to exist or develop on other products
of this same type design. For that reason, we are proposing this AD,
which would require at the next HPT module exposure:
     Removing the reduced cooling flow 2nd stage HPT vane
assemblies.
     Visual and fluorescent penetrant inspections of the 2nd
stage HPT air seal assemblies that have operated in an engine with
reduced cooling flow 2nd stage HPT vane assemblies.

Costs of Compliance

    Because this proposed AD is superseding an existing AD to remove
the seal assembly P/N, this proposed AD would not add any additional
costs beyond the costs included in the original AD.

Authority for This Rulemaking

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

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD. See the ADDRESSES section for a location
to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Under the authority delegated to me by the Administrator, the
Federal Aviation Administration proposes to amend 14 CFR part 39 as
follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-15180 (72 FR
48549, August 24, 2007), and by adding a new airworthiness directive to
read as follows:

Pratt & Whitney (PW): Docket No. FAA-2006-23742; Directorate
Identifier 2005-NE-53-AD.

Comments Due Date

    (a) The Federal Aviation Administration (FAA) must receive
comments on this airworthiness directive (AD) action by January 8,
2008.

Affected ADs

    (b) This AD supersedes AD 2007-17-21, Amendment 39-15180.

Applicability

    (c) This AD applies to Pratt & Whitney (PW) JT9D-7R4G2, -7R4E1,
-7R4E4, and -7R4H1 series turbofan engines. These engines are
installed on, but not limited to, Boeing 747-200, -300, 767-200, and
Airbus A300-600 and A310-300 series airplanes.

Unsafe Condition

    (d) This AD results from the manufacturer identifying additional
part numbers (P/N) air seal assemblies that are affected by the
unsafe condition. We are issuing this AD to prevent uncontained
failure of the 2nd stage high pressure turbine (HPT) air seal
assembly, leading to engine in-flight shutdown and damage to the
airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed at the next HPT module exposure after the effective
date of this AD, unless the actions have already been done.
    (f) At the next HPT module exposure, remove reduced cooling flow
2nd stage HPT vane assemblies P/Ns: 797282, 796972, 800082, 800072,
803182, 803282, and 822582, installed in 2nd stage HPT vane cluster
assemblies: P/Ns 797592, 797372, 799872, 799782, and 822572.
    (g) For 2nd stage HPT air seals that have operated in an engine
with reduced cooling flow HPT vane assemblies, at the next HPT
module exposure do the following:
    (1) Perform a onetime visual inspection of the 2nd stage HPT air
seal assembly. The

JT9D-7R4 engine manual, Section 72-51-22, Inspection/Check-01,
paragraphs 1.D.(1), 1.D.(4), and 1.D.(6) contains instructions for
the visual inspection.
    (2) Perform a fluorescent penetrant inspection (FPI) of the 2nd
stage HPT air seal assembly for cracks. The JT9D-7R4 engine manual,
Section 72-51-00, Inspection/Check-03, contains instructions for the
FPI.

Definition

    (h) For the purpose of this AD, we define an HPT module exposure
as removing the 1st stage HPT rotor or the 2nd stage HPT rotor from
the HPT case.

Alternative Methods of Compliance

    (i) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (j) Pratt & Whitney Alert Service Bulletin JT9D-7R4-A72-596,
dated September 15, 2005, contains information for modifying the
reduced cooling flow 2nd stage HPT vane assemblies.
    (k) Contact Mark Riley, Aerospace Engineer, Engine Certification
Office, FAA, Engine and Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803; e-mail<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, for more information
about this AD.

    Issued in Burlington, Massachusetts, on November 2, 2007.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E7-22005 Filed 11-8-07; 8:45 am]

BILLING CODE 4910-13-P


Johnd Bachmann 12/ 08/ 2003 07: 13 PM To: Amy_ L._ Farrell@ omb. eop. gov cc: Jeff Holmstead/ DC/ USEPA/ US@ EPA, Bill Wehrum/ DC/ USEPA/ US@ EPA, Stephanie Daigle/ DC/ USEPA/ US@ EPA, Don Zinger/ DC/ USEPA/ US@ EPA, Peter Tsirigotis/ RTP/ USEPA/ US@ EPA Subject: Part I of Revised Insterstate Air Quality Rule Transmission This is the first of two transmissions of revised and new sections of the IAQR. For ease of review, we are sending the revised sections, which incorporate comments from the Interagency review as well as additional internal reviews, in both redline and ' clean' versions.

This first transmission contains the following revised sections: I, II, IV, V, VIII, and IX, and the complete versions of the final two sections X, and XI. These last two include additional information on benefits and reg review requirements.

We will send the remaining revised sections tommorrow morning, including sections III, VI, and VII.

Thanks for your patience and cooperation in this.

John Bachmann U. S. EPA C404 04 Research Triangle Park, NC27711 Voice 919 541 5359 Fax 919 541 2464 email Bachmann. JohnD@ epa. gov