I was mistaken in our conversation.  The gasifier is actually in the Exxon

Mobil Baytown Chemical Plant, adjacent to the Baytown Refinery.  It uses

deasphalter pitch from the refinery, but produces gas for use in the

chemical plant.

James Childress

Executive Director

Gasification Technologies Council

phone:<PHONE_NUMBER>

mobile:<PHONE_NUMBER>

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Friday, July 27, 2007 12:02 PM

To<EMAIL_ADDRESS> Subject: RE: Refineries Using Gasification

My notes, per an earlier discussion we had, identifies another gasifier

operating at a refinery in Baytown, Texas  using petroleum resids.  This is

not on your list of 19.  Is this gasification not at a refinery?

Elaine Eby

U.S. Environmental Protection Agency

Office of Solid Waste/Hazardous Waste Management and Minimization Division

1200 Pennsylvania Avenue, N.W. Ariel Rios Building (Mail Code 5302W)

Washington, DC  20460

voice:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

             "James

             Childress"

             <jchil@jchildres                                        To

             s.com>                   Elaine Eby/DC/USEPA/US@EPA

                                                                     cc

             07/27/2007 11:48

             AM                                                 Subject

                                      RE: Refineries Using Gasification

              Please respond

                    to

             <jchil@jchildres

                  s.com>

Elaine,

The Excel file lists 19 refineries using gasification worldwide.  It lists

two U.S. refineries using gasification.  The spreadsheet also lists the

feedstocks and uses of the syngas.  I don't understand the question.

Jim

James Childress

Executive Director

Gasification Technologies Council

phone:<PHONE_NUMBER>

mobile:<PHONE_NUMBER>

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Friday, July 27, 2007 11:01 AM

To<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS> Subject: Re: Refineries Using Gasification

Jim-

I'm trying to resolve the discrepancies between the file you sent me

(below) and our earlier conversation on the number of refineries operating

gasification systems in the U.S..  According to your records at the GTC,

could you please identify the number of petroleum refineries that are

operating gasification units and for what purpose? This would exclude El

Dorado and any planned gasifier at a refinery.  Your help again is

appreciated.  Elaine

Elaine Eby

U.S. Environmental Protection Agency

Office of Solid Waste/Hazardous Waste Management and Minimization Division

1200 Pennsylvania Avenue, N.W. Ariel Rios Building (Mail Code 5302W)

Washington, DC  20460

voice:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

             "James

             Childress"

             <jchil@jchildres                                        To

             s.com>                   Elaine Eby/DC/USEPA/US@EPA

                                                                     cc

             07/16/2007 03:38         William Brandes/DC/USEPA/US@EPA

             PM                                                 Subject

                                      Refineries Using Gasification

              Please respond

                    to

             <jchil@jchildres

                  s.com>

Elaine,

A search of our online database indicates a total of 19 refineries around

the world in which gasification units are operating.  A table with these

plants listed is attached.

I hope this is helpful.

Jim Childress

James Childress

Executive Director

Gasification Technologies Council

phone:<PHONE_NUMBER>

mobile:<PHONE_NUMBER>(See attached file: Refineries Using

Gasification.xls)


[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18931-18932]
[FR Doc No: 2016-07356]

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

SECURITIES AND EXCHANGE COMMISSION

[OMB Control No. 3235-0217, SEC File No. 270-224]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 17e-1.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') has submitted
to the Office of Management and Budget (``OMB'') a request for
extension of the previously approved collection of information
described below.
    Rule 17e-1 (17 CFR 270.17e-1) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) (the ``Investment Company Act'') deems a
remuneration as ``not exceeding the usual and customary broker's
commission'' for purposes of Section 17(e)(2)(A) if, among other
things, a registered investment company's (``fund's'') board of
directors has adopted procedures reasonably designed to provide that
the remuneration to an affiliated broker is a reasonable and fair
amount compared to that received by other brokers in connection with
comparable transactions involving similar securities being purchased or
sold on a securities exchange during a comparable period of time and
the board makes and approves such changes as it deems necessary. In
addition, each quarter, the board must determine that all transactions
effected under the rule during the preceding quarter complied with the
established procedures. Rule 17e-1 also requires the fund to (i)
maintain permanently a written copy of the procedures adopted by the
board for complying with the requirements of the rule; and (ii)
maintain for a period of six years, the first two in an easily
accessible place, a written record of each transaction subject to the
rule, setting forth the amount and source of the commission, fee, or
other remuneration received; the identity of the broker; the terms of
the transaction; and the materials used to determine that the
transactions were effected in compliance with the procedures adopted by
the board. The recordkeeping requirements under rule 17e-1 enable the
Commission to ensure that affiliated brokers receive compensation that
does not exceed the usual and customary broker's commission. Without
the recordkeeping requirements, Commission inspectors would have
difficulty ascertaining whether funds were complying with rule 17e-1.
    Based on an analysis of fund filings, the staff estimates that
approximately 320 funds enter into subadvisory agreements each year.\1\
Based on discussions with industry representatives, the staff estimates
that it will require approximately 3 attorney hours to draft and
execute additional clauses in new subadvisory contracts in order for
funds and subadvisers to be able to rely on the exemptions in rule 17e-
1. Because these additional clauses are identical to the clauses that a
fund would need to insert in their subadvisory contracts to rely on
rules 12d3-1, 10f-3, and 17a-10, and because we believe that funds that
use one such rule generally use all of these rules, we apportion this 3
hour time burden equally to all four rules. Therefore, we estimate that
the burden allocated to rule 17e-1 for this contract change would be
0.75 hours.\2\ Assuming that all 320 funds enter into new subadvisory
contracts each year make the modification to their contract required by
the rule, we estimate that the rule's contract modification requirement
will result in 240 burden hours annually.\3\
---------------------------------------------------------------------------

    \1\ Based on data from Morningstar, as of September, 2015, there
are 12,426 registered funds (open-end funds, closed-end funds, and
exchange-traded funds), 4,683 funds of which have subadvisory
relationships (approximately 38%). Based on data from the 2015 ICI
Factbook, 843 new funds were established in 2014 (654 open-end funds
+ 176 exchange-traded funds + 13 closed-end funds (from the ICI
Research Perspective, April 2015)). 843 new funds x 38% = 320 funds.
    \2\ 3 hours / 4 rules = 0.75 hours.
    \3\ This estimate is based on the following calculation: 0.75
hours x 320 funds = 240 burden hours.
---------------------------------------------------------------------------

    Based on an analysis of fund filings, we estimate that
approximately 1,696 funds use at least one affiliated broker. Based on
staff experience and conversations with fund representatives, the staff
estimates approximately 40 percent of transactions (and thus, 40% of
funds) that occur under the rule 17e-

1 would be exempt from its recordkeeping and review requirements. This
would leave approximately 1,018 funds \4\ still subject to the rule's
recordkeeping and review requirements. Based on staff experience and
conversations with fund representatives, we estimate that the burden of
compliance with rule 17e-1 is approximately 50 hours per fund per year.
This time is spent, for example, reviewing the applicable transactions
and maintaining records. Accordingly, we calculate the total estimated
annual internal burden of complying with the review and recordkeeping
requirements of rule 17e-1 to be approximately 50,900 hours,\5\ and the
total annual burden of the rule's paperwork requirements is 51,140
hours.\6\
---------------------------------------------------------------------------

    \4\ 1,696 funds x 0.6 = 1,018 funds.
    \5\ 1,018 funds x 50 hours per fund = 50,900 hours.
    \6\ 240 hours + 50,900 hours = 51,140 hours.
---------------------------------------------------------------------------

    Estimates of the average burden hours are made solely for the
purposes of the Paperwork Reduction Act and are not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms. The collection of information under rule
17e-1 is mandatory. The information provided under rule 17e-1 will not
be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: March 29, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-07356 Filed 3-31-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Rules and Regulations]
[Pages 8146-8149]
[FR Doc No: 2016-03331]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2011-N-0661]

Effective Date of Requirement for Premarket Approval for Total
Metal-on-Metal Semi-Constrained Hip Joint Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to require the filing of a premarket approval application (PMA)
or a notice of completion of a product development protocol (PDP) for
the hip joint metal/metal semi-constrained, with a cemented acetabular
component, prosthesis; and hip joint metal/metal semi-constrained, with
an uncemented acetabular component, prosthesis.

DATES: This order is effective on February 18, 2016.

FOR FURTHER INFORMATION CONTACT: Sergio M. de del Castillo, Center for
Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66,
Rm. 1538, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub.
L. 107-250), the Medical Devices Technical Corrections Act (Pub. L.
108-214), the Food and Drug Administration Amendments Act of 2007 (Pub.
L. 110-85), and the Food and Drug Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112-144), among other amendments, established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type (both the preamendments and substantially
equivalent devices are referred to as preamendments class III devices)
may be marketed without submission of a PMA until FDA issues a final
order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval. Section 515(b)(1) of the FD&C Act directs
FDA to issue an order requiring premarket approval for a preamendments
class III device.
    Although, under the FD&C Act, the manufacturer of a preamendments
class III device may respond to the call for PMAs by filing a PMA or a
notice of completion of a PDP. In practice, the option of filing a
notice of completion of a PDP has rarely been used. For simplicity,
although the PDP option remains available to manufacturers in response
to a final order under section 515(b) of the FD&C Act, this document
will refer only to the requirement for the filing of, and obtaining
approval of, a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act, changing the process for
reclassifying a device from rulemaking to an administrative order.
Section 608(b) of FDASIA amended section 515(b) of the FD&C Act,
changing the process for requiring premarket approval for a
preamendments class III device from rulemaking to an administrative
order.
    FDA is requiring PMAs for total metal-on-metal (MoM) semi-
constrained hip joint systems (heretofore referenced as ``MoM hips''),
which include the following two specific preamendments class III
devices: Hip joint metal/metal semi-constrained, with a cemented
acetabular component, prosthesis; and hip joint metal/metal semi-
constrained, with an uncemented acetabular component, prosthesis.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order requiring premarket approval for a preamendments class III
device, the following must occur: (1) Publication of a proposed order
in the Federal Register; (2) a meeting of a device classification panel
described in section 513(b) of the FD&C Act; and (3) consideration of
comments from all affected stakeholders, including patients, payors,
and providers. FDA published a proposed order to require PMAs for MoM
hips in the Federal Register of January 18, 2013 (78 FR 4094), and
convened a meeting of a device classification panel for MoM hips as
discussed in the proposed order and in this document.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination.
    A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order (a final
rule issued

under section 515(b) of the FD&C Act prior to the enactment of FDASIA
is considered to be a final order for purposes of section 501(f) of the
FD&C Act (21 U.S.C. 351(f))) requiring premarket approval for the
device, or 30 months after final classification of the device under
section 513 of the FD&C Act, whichever is later. For MoM hips, the
later of these two time periods is the 90-day period. Therefore,
section 501(f)(2)(B) of the FD&C Act requires that a PMA for such
devices be filed within 90 days of the date of issuance of this final
order. If a PMA is not filed for such devices within 90 days after the
issuance of this final order, the devices will be deemed adulterated
under section 501(f) of the FD&C Act.
    Also, a preamendments device subject to the order process under
section 515(b) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see part 812 (21 CFR part 812))
contemporaneous with its interstate distribution until the date
identified by FDA in the final order, requiring the filing of a PMA for
the device. At that time, an IDE is required only if a PMA has not been
filed. If the manufacturer, importer, or other sponsor of the device
submits an IDE application and FDA approves it, the device may be
distributed for investigational use. If a PMA is not filed by the later
of the two dates, and the device is not distributed for investigational
use under an IDE, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334), if
its distribution continues. Other enforcement actions include, but are
not limited to, the following: Shipment of devices in interstate
commerce may be subject to injunction under section 302 of the FD&C Act
(21 U.S.C. 332), and the individuals responsible for such shipment may
be subject to prosecution under section 303 of the FD&C Act (21 U.S.C.
333).
    FDA held a meeting of a device classification panel described in
section 513(b) of the FD&C Act with respect to MoM hips on August 8,
2001, and therefore, has met this requirement under section 515(b)(1)
of the FD&C Act. The panel recommended that the devices remain in class
III because there was insufficient information to establish special
controls; the panel also agreed unanimously that MoM hips are for a use
which is of substantial importance in preventing impairment of human
health (Ref. 1). FDA is not aware of new information that would provide
a basis for a different recommendation or findings, and the recent
reports and evaluations discussed in the proposed order further support
that reclassification of MoM hips is not appropriate. Furthermore, the
problems identified in the medical device reporting systems and recalls
for MoM hips further indicate the need to review these devices under a
PMA to provide reasonable assurance of their safety and effectiveness.
    FDA received and has considered several sets of comments from nine
commenters on the proposed order, as discussed in section II.

II. Public Comments in Response to the Proposed Order

    In response to the January 18, 2013 (78 FR 4094), proposed order to
require premarket approval for MoM hips, FDA received several sets of
comments from nine commenters. These comments, as well as the Agency's
consideration of them, are summarized further in this section.
    Six commenters generally agreed with FDA's proposal to require PMAs
for MoM hips. One commenter (the American Academy of Orthopaedic
Surgeons, also referred to as AAOS) stated that the existing data is
not adequate to support reclassification of MoM hips because special
controls could not be established to provide a reasonable assurance of
device safety and effectiveness. This comment echoes the findings and
recommendations of the August 8, 2001, panel.
    Another commenter stated that MoM hip resurfacing devices should be
classified as Class III; however, MoM hip resurfacing devices are not
regulated under 21 CFR 888.3320 or 21 CFR 888.3330 and are not the
subject of this order.
    Several commenters requested that all currently marketed MoM hips
be removed from the market, either through a FDA-initiated recall or
voluntary action by the device manufacturer.
    As explained in more detail in section III of this order, if a PMA
for a currently marketed MoM hip is not filed on or before the 90th day
past the effective date of this order, that device will be deemed
adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial
distribution of the device must cease immediately. FDA intends to take
appropriate action to ensure compliance with the 90-day deadline for
the submission of PMAs. The Agency believes this information adequately
addresses the commenters' concern.
    One commenter recommended standardizing the modularity and other
design features of MoM hips to mitigate adverse events attributed to
the manufacturing process for these devices. The Agency does not
believe sufficient information exists to establish any manufacturing
standards or specific technical specifications for MoM hips that could
potentially be generalized for this technology to mitigate adverse
events.
    One commenter requested that the Agency set revision surgery
standards. Revision surgery involves a complex clinical decision that
falls within the practice of medicine, which FDA generally does not
regulate. In addition, insufficient information exists to establish any
standards for revision surgery. FDA notes, however, that the American
Association of Hip and Knee Surgeons, the American Academy of
Orthopaedic Surgeons, and the Hip Society issued a consensus statement
regarding assessment of risks in patients implanted with MoM hips,
including factors to consider for revision surgery, based on currently
available information (Ref. 2). FDA's Web site for MoM hips also
provides some general considerations regarding revision surgery (Ref.
3).
    One commenter requested that MoM hips not be used in women,
including those of child-bearing age, and children who are still
growing (i.e., skeletally immature). As noted in the proposed order and
as presented during the June 27-28, 2012, panel meeting, labeling for
MoM hips includes warnings or contraindications for skeletally immature
patients and patients who are pregnant or who may become pregnant (Ref.
4). In addition, the Agency will review all data included in the
required PMA for a MoM hip to determine what information needs to be
included in the device labeling to assure its safe and effective use,
including any warnings and contraindications. The removal of any
current contraindications for these patient populations would need to
be supported by valid scientific evidence, in accordance with 21 CFR
860.7.
    One commenter requested the adoption of standards for metal ion
levels in the serum of patients implanted with a MoM hip. As discussed
in detail during the June 28, 2012, panel meeting, there are challenges
to implementing metal ion testing into clinical evaluations of patients
treated with MoM hips, as well as challenges in the interpretation of
metal ion testing results (Ref. 5). For example, the equipment and
expertise required to conduct such testing are currently not widely
available in health care facilities. In addition, there can be
significant variability in test results, based on a number of factors,
including

the laboratory conducting the testing (inter-laboratory variability)
and the specific MoM hip implanted in the patient. Further,
insufficient information exists to establish a definitive correlation
between metal ion levels and clinical outcomes. Therefore, the Agency
does not believe such standards can be adequately developed at this
time. Nonetheless, the Agency acknowledges the importance of using
metal ion levels within the overall clinical assessment of patients
implanted with MoM hips. On May 6, 2011, under section 522 of the FD&C
Act (21 U.S.C. 360l), FDA ordered manufacturers of MoM hips to conduct
postmarket surveillance studies of these devices. As part of these
studies, manufacturers are required to study the effects of metal ion
concentrations in the bloodstream. The Agency will use the data from
these studies to determine if any additional recommendations can be
developed with respect to metal ion levels.
    One commenter stated that FDA should affirmatively assert that
common law liability claims relating to MoM hips that are included
under this final order, which were cleared through the 510(k) process
before the effective date of this final order, should not be preempted
under section 521 of the FD&C Act (21 U.S.C. 360k). Section 521 of the
FD&C Act includes an express preemption provision that preempts certain
state requirements that are ``different from, or in addition to''
certain Federal requirements applicable to devices. Two Supreme Court
cases: Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) and Riegel v.
Medtronic, Inc., 552 U.S. 312 (2008), address the scope of this
provision. In Lohr, the Court held that design defect, manufacturing,
and failure to warn claims relating to a 510(k)-cleared device were not
preempted because there were no Federal ``requirements'' imposed by the
510(k) review where (1) the device could ``take any particular form for
any particular reason,'' and (2) the general Federal manufacturing and
labeling requirements were not specific to the device in question. Id.
at 493, 497-502. In contrast, the Court determined in Riegel that the
PMA review imposed Federal ``requirements'' under section 521 of the
FD&C Act because FDA required that the PMA-approved device be made with
almost no deviations from the specifications in the approved PMA. 552
U.S. at 323. The Riegel Court went on to hold that the Riegels' common
law claims were preempted where New York law imposed requirements on
the PMA-approved device that were ``different from, or in addition to''
the Federal requirements. Id. at 327-330. As seen in these cases, the
preemption analysis under section 521 of the FD&C Act depends on
whether ``requirements'' imposed by State law are different from or in
addition to ``requirements'' imposed by Federal law. This determination
involves resolution of a number of critical factual issues, including
identifying the applicable State and Federal (if any) requirements that
relate to the claims asserted, defining the scope of those
requirements, and evaluating their relationship to one another.
Although Lohr may be relevant to the situation described in the
comment, FDA notes that the inquiry into preemption needs to consider
the context and all relevant facts. The situation described in the
comment is fairly generalized, and as such, FDA believes it would not
be helpful to opine on this issue at this point in time.
    Finally, several comments recommended actions that address broader
issues or programmatic areas, such as changes to the postmarket
surveillance process for all class III medical devices, recommendations
for research studies, and the establishment of a ``trust fund'' for
healthcare reimbursement of failed MoM hips. These requests are outside
the scope of the regulatory actions described in this order.

III. The Final Order

    Under section 515(b)(3) of the FD&C Act, FDA is adopting its
findings as published in the proposed order (78 FR 4094), and is
issuing this final order to require the filing of a PMA for MoM hips,
which specifically includes the following two device types: Hip joint
metal/metal semi-constrained, with a cemented acetabular component,
prosthesis; and hip joint metal/metal semi-constrained, with an
uncemented acetabular component, prosthesis. This final order will
revise 21 CFR part 888.
    Under the final order, a PMA is required to be filed on or before
May 18, 2016, for any of these preamendments class III devices that
were in commercial distribution before May 28, 1976, or that has been
found by FDA to be substantially equivalent to such a device on or
before May 18, 2016. An applicant of a device subject to this order
that was legally in commercial distribution before May 28, 1976, or
that has been found to be substantially equivalent to a device that was
legally in commercial distribution before May 28, 1976, may continue
marketing such class III device during FDA's review of the PMA provided
that the PMA is filed on or before May 18, 2016. However, if FDA denies
approval of the PMA, then the device will be deemed adulterated under
section 501(f)(1)(A) of the FD&C Act, and commercial distribution of
the device must cease immediately. Any other device subject to this
order is required to have an approved PMA in effect before it may be
marketed. FDA intends to review any PMA for the device within 180 days,
and any notice of completion of a PDP for the device within 90 days of
the date of filing. FDA cautions that under section 515(d)(1)(B)(i) of
the FD&C Act, the Agency may not enter into an agreement to extend the
review period for a PMA beyond 180 days unless the Agency finds that
``the continued availability of the device is necessary for the public
health.''
    If a PMA for any of the preamendments class III devices subject to
this order is not filed on or before May 18, 2016, that device will be
deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and
commercial distribution of the device must cease immediately. FDA
requests that manufacturers take action to prevent the further use of
MoM hips for which no PMA has been filed.
    The device may, however, be distributed for investigational use, if
the applicable requirements of the IDE regulations (part 812),
including obtaining IDE approval, are met on or before 90 days after
the effective date of this order. There will be no extended period for
filing an IDE or exemption from the IDE requirements (see Sec.
812.2(d)), and clinical studies may not be initiated without
appropriate IDE approvals, as required.

IV. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120;

the collections of information in 21 CFR part 814, subpart B, have been
approved under OMB control number 0910-0231; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.

VI. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) of the FD&C Act
provided for FDA to issue regulations to require approval of an
application for premarket approval for preamendments devices or devices
found substantially equivalent to preamendments devices. Section 515(b)
of the FD&C Act, as amended by FDASIA, provides for FDA to require
approval of an application for premarket approval for such devices by
issuing a final order following the issuance of a proposed order in the
Federal Register. FDA will continue to codify the requirement for an
application for premarket approval in the Code of Federal Regulations
(CFR). Therefore, under section 515(b)(1) of the FD&C Act, as amended
by FDASIA, in this final order, FDA is requiring approval of an
application for premarket approval for total MoM semi-constrained hip
joint systems, which include the following two specific preamendments
class III devices: Hip joint metal/metal semi-constrained, with a
cemented acetabular component, prosthesis; and hip joint metal/metal
semi-constrained, with an uncemented acetabular component, prosthesis;
and the Agency is making the language in 21 CFR 888.3320 and 888.3330
consistent with this final order.

VII. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

1. FDA, Orthopaedic and Rehabilitation Devices Panel transcript,
August 8, 2001. Available at http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3780t1.rtf.
2. Kwon et al. ``Risk Stratification Algorithm for Management of
Patients with Metal-on-Metal Hip Arthroplasty.'' Journal of Bone and
Joint Surgery, American Volume, 96:e4, 2014.
3. FDA, Metal-on-Metal Hip Implants Web site, Information for
Orthopaedic Surgeons. Available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm.
4. FDA, Orthopaedic and Rehabilitation Devices Panel, FDA Executive
Summary, June 27-28, 2012. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309302.pdf.
5. FDA, Orthopaedic and Rehabilitation Devices Panel transcript,
June 28, 2012. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM313605.pdf.

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for 21 CFR part 888 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 888.3320 is amended by revising paragraph (c) to read as
follows:

Sec.  888.3320  Hip joint metal/metal semi-constrained, with a cemented
acetabular component, prosthesis.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or a
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before May 18, 2016, for any hip joint metal/
metal semi-constrained prosthesis with a cemented acetabular component
that was in commercial distribution before May 28, 1976, or that has,
on or before May 18, 2016, been found to be substantially equivalent to
a hip joint metal/metal semi-constrained prosthesis with a cemented
acetabular component that was in commercial distribution before May 28,
1976. Any other hip joint metal/metal semi-constrained prosthesis with
a cemented acetabular component shall have an approved PMA or a
declared completed PDP in effect before being placed in commercial
distribution.

0
3. Section 888.3330 is amended by revising paragraph (c) to read as
follows:

Sec.  888.3330  Hip joint metal/metal semi-constrained, with an
uncemented acetabular component, prosthesis.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or a
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before May 18, 2016, for any hip joint metal/
metal semi-constrained prosthesis with an uncemented acetabular
component that was in commercial distribution before May 28, 1976, or
that has, on or before May 18, 2016, been found to be substantially
equivalent to a hip joint metal/metal semi-constrained prosthesis with
an uncemented acetabular component that was in commercial distribution
before May 28, 1976. Any other hip joint metal/metal semi-constrained
prosthesis with an uncemented acetabular component shall have an
approved PMA or a declared completed PDP in effect before being placed
in commercial distribution.

    Dated: February 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03331 Filed 2-17-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
[Page 38150]
[FR Doc No: 2022-13636]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-9502-000]

Brown, Michael K.; Notice of Filing

    Take notice that on May 23, 2022, Michael K. Brown submitted for
filing, application for authority to hold interlocking positions,
pursuant to section 305(b) of the Federal Power Act, 16 U.S.C. 825d (b)
and Part 45.8 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure, 18 CFR part 45.8.
    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. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on June 28, 2022.

    Dated: June 21, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-13636 Filed 6-24-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Notices]
[Page 69064]
[FR Doc No: 2021-26390]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0631]

Guidance: Change 3 to NVIC 19-14 Policy on Qualified Assessors

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability.

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

SUMMARY: The Coast Guard announces the availability of Change 3 to
Navigation and Vessel Inspection Circular (NVIC) 19-14 Policy on
Qualified Assessors (QAs). This NVIC provides guidance to mariners
concerning assessments of competence for STCW endorsements. This change
notice revises NVIC 19-14 to indicate that until June 30, 2024, the
Coast Guard will accept assessments of competence that are signed
before January 1, 2024, by a person who is not a Coast Guard approved
QA.

DATES: The policies announced in Change-3 to NVIC 19-14 are effective
as of October 29, 2021.

ADDRESSES: To view documents mentioned in this notice, search the
docket number USCG-2021-0631 using the Federal eRulemaking Portal at
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For information about this document,
contact James Cavo, Mariner Credentialing Program Policy Division (CG-
MMC-2), Coast Guard; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION: Assessments of competence for STCW
endorsements must be signed by a Coast Guard-approved QA in accordance
with 46 CFR 11.301(a)(1)(i) and 12.601(b)(1)(i). QAs must be approved
by the Coast Guard either individually or as part of a Coast Guard-
approved or accepted course or training program, as described in
Navigation and Vessel Inspection Circular (NVIC) 19-14 (Policy on
Qualified Assessors).
    Current policy allows for the acceptance of STCW assessments,
performed for and signed by an assessor not approved by the Coast
Guard, until December 31, 2021. Such an assessor must meet the
professional requirements in 46 CFR 10.405(a)(3) to determine
competence for the specific endorsement.
    The Coast Guard is aware that as a result of the limited number of
approved QAs, there may be a hardship on mariners trying to complete
STCW assessments after December 31, 2021. In consideration of this, the
Coast Guard will continue to allow STCW assessments to be signed by an
assessor who meets the requirements specified in NVIC 19-14 until
December 31, 2023. These assessments must be submitted to the Coast
Guard as part of a complete application no later than June 30, 2024.
Qualified military personnel need not be approved QAs and may continue
to sign assessments after December 31, 2023.
    In addition, we will update the deadlines for QAs in other NVICs
and guidance to reflect the new deadlines announced in CH-3 NVIC 19-14.
    This notice is issued under authority of 5 U.S.C. 552(a).

    Dated: October 29, 2021.
J.W. Mauger,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention
Policy.
[FR Doc. 2021-26390 Filed 12-3-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Notices]
[Pages 68066-68067]
[FR Doc No: 2020-23729]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC21-10-000.
    Applicants: NextEra Energy Transmission, LLC, GridLiance West LLC,
GridLiance High Plains LLC, GridLiance HeartLand LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act, et al. of NextEra Energy Transmission, LLC,
et al.
    Filed Date: 10/20/20.
    Accession Number: 20201020-5121.
    Comments Due: 5 p.m. ET 11/10/20.

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

    Docket Numbers: ER19-2757-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2020-10-21 Compliance Filing FERC
Order No. 831 to be effective 3/21/2021.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5078.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER20-2360-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2020-10-21 Compliance Filing--
CCDEBE to be effective 12/31/9998.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5081.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-160-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Tariff Cancellation: DEF--Cancellations of Rate
Schedule Nos. 220, 219, 126 and 194 to be effective 1/1/2021.
    Filed Date: 10/20/20.
    Accession Number: 20201020-5084.
    Comments Due: 5 p.m. ET 11/10/20.

    Docket Numbers: ER21-161-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
MidAmerican Energy Company.
    Description: Sec.  205(d) Rate Filing: 2020-10-20_MidAmerican ADIT
Proration Filing to be effective 1/1/2021.
    Filed Date: 10/20/20.
    Accession Number: 20201020-5091.
    Comments Due: 5 p.m. ET 11/10/20.

    Docket Numbers: ER21-162-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: PJM submits Revisions to
OATT and OA re:

Economic Planning Process to be effective 12/21/2020.
    Filed Date: 10/20/20.
    Accession Number: 20201020-5100.
    Comments Due: 5 p.m. ET 11/10/20.

    Docket Numbers: ER21-163-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 5830; Queue No. AF2-268 to be effective 9/21/2020.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5027.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-164-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 5826; Queue No. AF2-215 to be effective 9/21/2020.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5035.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-165-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3127R2 Montana-Dakota
Utilities Co. NITSA and NOA to be effective 10/1/2020.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5037.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-166-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-Oncor Electric
Delivery Company 4th A&R Interconnection Agreement to be effective 10/
10/2020.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5053.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-167-000.
    Applicants: Montour, LLC.
    Description: Tariff Cancellation: Notice of Cancellation of
Superseded Certificates of Concurrence to be effective 9/30/2020.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5060.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-168-000.
    Applicants: Montour, LLC.
    Description: Tariff Cancellation: Notice of Cancellation of
Superseded Certificates of Concurrence to be effective 9/30/2020.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5061.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-169-000.
    Applicants: Montana-Dakota Utilities Co., Basin Electric Power
Cooperative, Midcontinent Independent System Operator, Inc., Southwest
Power Pool, Inc.
    Description: Compliance filing: Amendment No. 1 to Partial
Settlement in ER14-2850-006 and ER14-2851-006 to be effective N/A.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5075.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-170-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: RS 319 Suppl 5 PSCo-TriState
PTSA to be effective 1/1/2021.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5083.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER21-171-000.
    Applicants: Tucson Electric Power Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement for Firm
Long Term Transmission Service to be effective 9/21/2020.
    Filed Date: 10/21/20.
    Accession Number: 20201021-5091.
    Comments Due: 5 p.m. ET 11/12/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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 21, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-23729 Filed 10-26-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 64 (Thursday, April 3, 2014)]
[Rules and Regulations]
[Pages 18622-18625]
[FR Doc No: 2014-07318]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0829; Directorate Identifier 2013-NM-085-AD;
Amendment 39-17814; AD 2014-06-10]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2010-23-12 for
certain Airbus Model A330 and Model A340 series airplanes. AD 2010-23-
12 required inspecting to determine the part number for Thales Avionics
Angle of Attack (AoA) probes, and replacing any affected probe with a
serviceable probe. This new AD adds airplanes to the applicability and,
for certain airplanes, requires that those affected probes be replaced.
This AD was prompted by reports that the AoA sensors on certain
airplanes were modified and re-identified without performing the
inspection to determine the part number; therefore, the affected probes
were not replaced with serviceable probes. We are issuing this AD to
prevent erroneous AoA information and consequent delayed activation or
non-activation of the AoA protection systems, which, in combination
with flight at a high angle of attack, could result in reduced
controllability of the airplane.

DATES: This AD becomes effective May 8, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 8, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of
December 14, 2010 (75 FR 68698, November 9, 2010).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.
    For Airbus service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 45 80; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington.
    For Thales Avionics service information identified in this AD,
contact Thales--Aerospace Division, 105, avenue du General Eisenhower--
BP 63647, 31036 Toulouse Cedex 1, France; telephone +33 (0)5 61 19 65
00; fax +33 (0)5 61 19 66 00; Internet http://www.thalesgroup.com/aerospace. You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call 425-
227-1221.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton,

Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2010-23-12, Amendment 39-16501 (75 FR 68698,
November 9, 2010). AD 2010-23-12 applied to certain Airbus Model A330
and Model A340 series airplanes. The NPRM published in the Federal
Register on September 26, 2013 (78 FR 59295). The NPRM was prompted by
reports that the AoA sensors on certain airplanes were modified and re-
identified without performing the inspection to determine the part
number; therefore, the affected probes were not replaced with
serviceable probes. The NPRM proposed to require inspecting to
determine the part number for Thales Avionics Angle of Attack (AoA)
probes, and replacing any affected probe with a serviceable probe. We
are issuing this AD to prevent erroneous AoA information and consequent
delayed activation or non-activation of the AoA protection systems,
which, in combination with flight at a high angle of attack, could
result in reduced controllability of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2013-0068, dated March 15, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    During Airbus Final Assembly Line reception flight tests, Angle
of Attack (AoA) data from two different aeroplanes were found
inaccurate, which was confirmed by flight data analysis.
    The results of the investigation conducted by Airbus and Thales
on the removed sensors revealed oil residue between the stator and
the rotor parts of the AoA vane position resolvers. This oil residue
was the result of incorrect removal of machining oil during the
manufacturing process of the AoA resolvers. At low temperatures,
this oil residue becomes viscous (typically in cruise) causing
delayed and/or reduced AoA vane movement. Multiple AoA sensors could
be simultaneously affected, providing incorrect indications of the
AoA of the aeroplane.
    This condition, if not corrected, could lead to erroneous AoA
information and consequent delayed activation or non-activation of
the AoA protection systems which, if during flight at a high angle
of attack, could result in reduced control of the aeroplane.
    To address this unsafe condition, EASA issued AD 2010-0016R1
[(http://ad.easa.europa.eu/blob/easa_ad_2013_0068.pdf/AD_2011-0007R1_1)] [which corresponds to FAA AD 2010-23-12, Amendment 39-
16501 (75 FR 68698, November 9, 2010)] to require the identification
of the serial number (S/N) of each installed Thales Avionics
(formerly SEXTANT), Part Number (P/N) C16291AA AoA sensor and the
replacement of all suspect units with serviceable one. EASA AD 2010-
0016R1 also prohibited the (re) installation of these same S/N AoA
sensors on any aeroplane, unless corrective measures had been
accomplished.
    Since that [EASA] AD was issued, it was discovered that a part
of the affected population of AoA sensors may have been modified and
re-identified from P/N C16291AA to P/N C16291AB, in accordance with
the instructions of Airbus Service Bulletin (SB) A330-34-3228 or SB
A340-34-5070, as applicable to aeroplane type, without having passed
the inspection in accordance with the instructions of Thales
Avionics SB C16291A-34-007, Revision 01.
    For the reasons described above, this new [EASA] AD retains the
requirements of EASA AD 2010-0016R1, which is superseded, [adds
airplanes to the applicability, and requires, for the affected
population that was not addressed by EASA AD 2010-0016R1, the
replacement of the suspect units with serviceable ones.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov.

Revised Service Information

    Since the NPRM (78 FR 59295, September 26, 2013) was published, we
have received the following service information:
     Airbus Mandatory Service Bulletin A330-34-3232, Revision
01, dated September 17, 2013 (for Model A330-200 and A330-300 series
airplanes);
     Airbus Mandatory Service Bulletin A340-34-4239, Revision
01, dated September 17, 2013 (for Model A340-200 and A340-300 series
airplanes); and
     Airbus Mandatory Service Bulletin A340-34-5072, Revision
01, dated September 17, 2013 (for Model A340-500, and A340-600 series
airplanes).

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.

Request To Include Revised Service Information

    Airbus asked that we include the service information identified
previously under ``Revised Service Information'' as a means of
compliance for accomplishing the required actions.
    We agree with the commenter and have included this new service
information in paragraph (i) of this AD. We have also given credit for
previous revisions of the service information by adding a new paragraph
(k) to this AD and redesignating subsequent paragraphs accordingly.

Change to Paragraph (g) of This AD

    The NPRM (78 FR 59295, September 26, 2013) contained a
typographical error in paragraph (g) of the NPRM. The last sentence of
paragraph (g) of the NPRM referred to ``paragraph (l) of this AD.''
Paragraph (l) of the NPRM contained the ``Other FAA AD Provisions''
text. The last sentence of paragraph (g) of the NPRM should have
referred to the ``Parts Installation Limitations'' text, which was in
paragraph (k) of the NPRM. However, we have not changed the last
sentence in paragraph (g) of this AD to refer to paragraph (k) of this
AD, because the reference to paragraph (l) of this AD is now correct.
As stated previously, a new paragraph (k) was added to this AD and,
therefore, paragraph (k) of the NPRM is now referred to as paragraph
(l) in this AD.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting
this AD with the changes described previously. We have determined that
these changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 59295, September 26, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 59295, September 26, 2013).

Costs of Compliance

    We estimate that this AD affects about 70 products of U.S.
registry.
    The actions that were required by AD 2010-23-12, Amendment 39-16501
(75 FR 68698, November 9, 2010), and are retained in this AD take about
3 work-hours per product, at an average labor rate of $85 per work
hour. Based on these figures, the estimated cost of the retained
required actions is $255 per product.
    We estimate that it takes about 9 work-hours per product to comply
with the new basic requirements of this AD. The average labor rate is
$85 per work-hour. Required parts cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these parts.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher

than estimated here. Based on these figures, we estimate the cost of
the AD on U.S. operators to be $53,550, or $765 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the optional terminating action specified in this
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 determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-0597; 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 AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone (800)
647-5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2010-23-12, Amendment 39-16501 (75 FR 68698, November 9, 2010), and
adding the following new AD:

2014-06-10 Airbus: Amendment 39-17814. Docket No. FAA-2013-0829;
Directorate Identifier 2013-NM-085-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective May 8, 2014.

(b) Affected ADs

    This AD supersedes AD 2010-23-12, Amendment 39-16501 (75 FR
68698, November 9, 2010).

(c) Applicability

    This AD applies to Airbus airplanes, certificated in any
category, as identified in paragraphs (c)(1) and (c)(2) of this AD,
    (1) Model A330-201, A330-202, A330-203, A330-223, A330-223F,
A330-243, A330-243F, A330-301, A330-302, A330-303, A330-321, A330-
322, A330-323, A330-341, A330-342, and A330-343 airplanes; all
manufacturer serial numbers.
    (2) Model A340-211, A340-212, A340-213, A340-311, A340-312,
A340-313, A340-541, and A340-642 airplanes; all manufacturer serial
numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 34: Navigation.

(e) Reason

    This AD was prompted by reports that the Angle of Attack (AoA)
sensors on certain airplanes were modified and re-identified without
performing the inspection to determine the part number; therefore,
the affected probes were not replaced with serviceable probes. We
are issuing this AD to prevent erroneous AoA information and
consequent delayed activation or non-activation of the AoA
protection systems, which, in combination with flight at a high
angle of attack, could result in reduced controllability of the
airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Retained Inspection of AoA Probes

    This paragraph restates the requirements of paragraph (g) of AD
2010-23-12, Amendment 39-16501 (75 FR 68698, November 9, 2010). For
airplanes on which an AoA sensor having part number (P/N) C16291AA
is installed, except as provided by paragraph (l) of this AD: Within
3 months after December 14, 2010 (the effective date of AD 2010-23-
12), perform a detailed inspection of the Thales Avionics AoA probes
having P/N C16291AA for a serial number identification, in
accordance with the Accomplishment Instructions of the applicable
service information identified in paragraphs (g)(1), (g)(2), and
(g)(3) of this AD. A review of airplane maintenance records is
acceptable in lieu of this inspection if the serial number of the
AoA probe can be conclusively determined from that review. If no AoA
probe having P/N C16291AA and a serial number identified in Thales
Service Bulletin C16291A-34-007, Revision 01, dated December 3,
2009, is identified during the inspection required by this paragraph
of this AD, no further action is required by this AD, except as
provided by paragraph (l) of this AD.
    (1) Airbus Mandatory Service Bulletin A330-34-3232, dated
January 20, 2010 (for Model A330-200 and A330-300 series airplanes).
    (2) Airbus Mandatory Service Bulletin A340-34-4239, dated
January 20, 2010 (for Model A340-200 and A340-300 series airplanes).
    (3) Airbus Mandatory Service Bulletin A340-34-5072, dated
January 20, 2010 (for Model A340-500, and A340-600 series
airplanes).

(h) Retained Replacement of Identified AoA Probes

    This paragraph restates the requirements of paragraph (h) of AD
2010-23-12, Amendment 39-16501 (75 FR 68698, November 9, 2010), with
clarified procedures. If the serial number of the AoA probe
identified during the inspection required by paragraph (g) of this
AD corresponds to a suspect AoA probe specified in Thales Service
Bulletin C16291A-34-007, Revision 01, dated December 3, 2009: At the
applicable time specified in paragraph (h)(1) or (h)(2) of this AD,
replace the affected AoA probe with a serviceable AoA probe, in
accordance with one of the four options and associated
Accomplishment Instructions specified in the applicable service
bulletin identified in paragraphs (g)(1), (g)(2), and (g)(3) of this
AD.
    (1) For airplanes on which Airbus Modification 53368 (back-up
speed scale) has been embodied in production or Airbus Service
Bulletin A330-34-3213, Airbus Service Bulletin A340-34-4213, or
Airbus Service Bulletin A340-34-5060, as applicable, has been
embodied in service:

Within 3 months after December 14, 2010 (the effective date of AD
2010-23-12, Amendment 39-16501 (75 FR 68698, November 9, 2010)).
    (2) For airplanes on which Airbus Modification 53368 (back-up
speed scale) has not been embodied in production and Airbus Service
Bulletin A330-34-3213, Airbus Service Bulletin A340-34-4213, or
Airbus Service Bulletin A340-34-5060, as applicable, has not been
embodied in service: Within 15 months after December 14, 2010 (the
effective date of AD 2010-23-12, Amendment 39-16501 (75 FR 68698,
November 9, 2010)).

(i) New Replacement of AoA Probes

    For airplanes on which an AoA probe having P/N C16291AA or
C16291AB, with a serial number identified in Thales Service Bulletin
C16291A-34-007, Revision 04, dated October 11, 2012, is installed,
except as provided by paragraph (l) of this AD: Within 6 months
after the effective date of this AD, replace any AoA probe having P/
N C16291AA or C16291AB with a serviceable AoA probe, in accordance
with the Accomplishment Instructions of the applicable service
information identified in paragraph (i)(1), (i)(2), or (i)(3) of
this AD. A review of airplane maintenance records is acceptable for
compliance with the requirements of this paragraph if the records
clearly demonstrate that the affected AoA probe has passed the
inspection specified in Thales Service Bulletin C16291A-34-007,
Revision 04, dated October 11, 2012.
    (1) Airbus Mandatory Service Bulletin A330-34-3232, Revision 01,
dated September 17, 2013.
    (2) Airbus Mandatory Service Bulletin A340-34-4239, Revision 01,
dated September 17, 2013.
    (3) Airbus Mandatory Service Bulletin A340-34-5072, Revision 01,
dated September 17, 2013.

(j) Exception to AD Requirements

    Airplanes on which Airbus Modification 58555 (installation of
AoA sensors with P/N C16291AB) or Airbus Modification 46921
(installation of AoA sensors with P/N 0861ED) has been embodied in
production are not affected by the requirements in paragraphs (g),
(h) and (i) of this AD, provided that no AoA sensor has been
replaced since first flight.

(k) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(i) of this AD, if those actions were performed before the effective
date of this AD using the service information identified in
paragraph (k)(1), (k)(2), or (k)(3) of this AD, as applicable, which
is not incorporated by reference in this AD.
    (1) Airbus Mandatory Service Bulletin A330-34-3232, dated
January 20, 2010 (for Model A330-200 and A330-300 series airplanes).
    (2) Airbus Mandatory Service Bulletin A340-34-4239, dated
January 20, 2010 (for Model A340-200 and A340-300 series airplanes).
    (3) Airbus Mandatory Service Bulletin A340-34-5072, dated
January 20, 2010 (for Model A340-500, and A340-600 series
airplanes).

(l) Parts Installation Limitations

    (1) For airplanes on which an AoA sensor having part number (P/
N) C16291AA is installed: As of December 14, 2010 (the effective
date of AD 2010-23-12, Amendment 39-16501 (75 FR 68698, November 9,
2010)) and until the effective date of this AD, no person may
install, on any airplane, a Thales Avionics AoA probe having P/N
C16291AA and a serial number identified in Thales Service Bulletin
C16291A-34-007, Revision 01, dated December 3, 2009, unless the AoA
is fitted with an inspection label stating that Thales Service
Bulletin C16291A-34-007, has been accomplished.
    (2) As of the effective date of this AD, no person may install,
on any airplane, a Thales Avionics AoA probe having P/N C16291AA or
P/N C16291AB and a serial number identified in Thales Service
Bulletin C16291A-34-007, Revision 04, dated October 11, 2012, unless
the AoA is fitted with an inspection label stating that Thales
Service Bulletin C16291A-34-007, has been accomplished.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
Airworthiness Directive 2013-0068, dated March 15, 2013, for related
information. You may examine the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0829-0002.
    (2) Service information identified in this AD that is not
incorporated by reference may be viewed at the address specified in
paragraphs (o)(5) and (o)(7) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 8, 2014.
    (i) Airbus Mandatory Service Bulletin A330-34-3232, Revision 01,
dated September 17, 2013.
    (ii) Airbus Mandatory Service Bulletin A340-34-4239, Revision
01, dated September 17, 2013.
    (iii) Airbus Mandatory Service Bulletin A340-34-5072, Revision
01, dated September 17, 2013.
    (iv) Thales Service Bulletin C16291A-34-007, Revision 04, dated
October 11, 2012.
    (4) The following service information was approved for IBR on
December 14, 2010 (75 FR 68698, November 9, 2010).
    (i) Airbus Mandatory Service Bulletin A330-34-3232, excluding
Appendix 01, dated January 20, 2010.
    (ii) Airbus Mandatory Service Bulletin A340-34-4239, excluding
Appendix 01, dated January 20, 2010.
    (iii) Airbus Mandatory Service Bulletin A340-34-5072, excluding
Appendix 01, dated January 20, 2010.
    (iv) Thales Service Bulletin C16291A-34-007, Revision 01, dated
December 3, 2009.
    (5) For Airbus service information identified in this AD,
contact Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (6) For Thales Avionics service information identified in this
AD, contact Thales--Aerospace Division, 105, avenue du General
Eisenhower--BP 63647, 31036 Toulouse Cedex 1, France; telephone +33
(0)5 61 19 65 00; fax +33 (0)5 61 19 66 00; Internet http://www.thalesgroup.com/aerospace.
    (7) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (8) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on March 17, 2014.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-07318 Filed 4-2-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Notices]
[Pages 57811-57812]
[FR Doc No: 2015-24450]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0010; FRL-9934-12]

Receipt of Test Data under the Toxic Substances Control Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing its receipt of test data submitted pursuant
to an enforceable consent agreement (ECA)/Order issued by EPA under the
Toxic Substances Control Act (TSCA). As required by TSCA, this document
identifies each chemical substance and/or mixture for which test data
have been received; the uses or intended uses of such chemical
substance and/or mixture; and describes the nature of the test data
received. Each chemical substance and/or mixture related to this
announcement is identified in Unit I. under SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kathy Calvo, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8089; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
I. Chemical Substances and/or Mixtures

    Information about the following chemical substances and/or mixtures
is provided in Unit IV.: 1,2-Ethylene Dichloride, (a/k/a Ethylene
Dichloride) (CAS RN 107-06-2).

II. Federal Register Publication Requirement

    Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a
notice in the Federal Register reporting the receipt of test data
submitted pursuant to ECAs/Orders promulgated under TSCA section 4 (15
U.S.C. 2603).

III. Docket Information

    A docket, identified by the docket identification (ID) number EPA-
HQ-OPPT-2003-0010, has been established for this Federal Register
document that announces the receipt of data. Upon EPA's completion of
its quality assurance review, the test data received will be added to
the docket for the ECA/Order that required the test data. Use the
docket ID number provided in Unit IV. to access the test data in the
docket for the related ECA/Order.
    The docket for this Federal Register document and the docket for
each related ECA/Order is available electronically at http://www.regulations.gov or in person at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

IV. Test Data Received

    This unit contains the information required by TSCA section 4(d)
for the test data received by EPA.

1,2-Ethylene Dichloride, (a/k/a Ethylene Dichloride) (CAS RN 107-06-2)
    1. Chemical Use(s): Chemical intermediate principally in the
production of vinyl chloride, but also vinylidene chloride, 1,1,1-
trichloroethane, trichloroethylene, tetrachloroethylene, aziridines,
and ethylene diamines. It is also used as a solvent.
    2. Applicable ECA/Order: 1,2-Ethylene Dichloride (EDC).
    3. Test Data Received: The following listing describes the nature
of the test data received. The test data will be added to the docket
for the applicable ECA/Order and can be found by referencing the docket
ID number provided. EPA reviews of test data will be added to the same
docket upon completion.
    a. Reproductive Toxicity (oral)/Neurotoxicity Study. The docket ID
number assigned to this data is EPA-HQ-OPPT-2003-0010.
    b. Physiologically-Based Pharmacokinetics (PBPK) Modeling of
Reproductive Toxicity (oral)/Neurotoxicity Study. The docket ID number
assigned to this data is EPA-HQ-OPPT-2003-0010.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: September 18, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2015-24450 Filed 9-24-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Notices]
[Pages 5933-5935]
[FR Doc No: 2022-02108]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2022-0002-N-2]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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

SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, FRA seeks approval of the Information
Collection Request (ICR) abstracted below. Before submitting this ICR
to the Office of Management and Budget (OMB) for approval, FRA is
soliciting public comment on specific aspects of the activities
identified in the ICR.

DATES: Interested persons are invited to submit comments on or before
April 4, 2022.

ADDRESSES: Written comments and recommendations for the proposed ICR
should be submitted on regulations.gov to the docket, Docket No. FRA-
2022-0002. All comments received will be posted without change to the
docket,

including any personal information provided. Please refer to the
assigned OMB control number in any correspondence submitted. FRA will
summarize comments received in response to this notice in a subsequent
notice and include them in its information collection submission to OMB
for approval.

FURTHER INFORMATION CONTACT: Ms. Hodan Wells, Information Collection
Clearance Officer, at email: [email protected] or telephone: (202)
493-0440.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
provide 60-days' notice to the public to allow comment on information
collection activities before seeking OMB approval of the activities.
See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. Specifically,
FRA invites interested parties to comment on the following ICR
regarding: (1) Whether the information collection activities are
necessary for FRA to properly execute its functions, including whether
the activities will have practical utility; (2) the accuracy of FRA's
estimates of the burden of the information collection activities,
including the validity of the methodology and assumptions used to
determine the estimates; (3) ways for FRA to enhance the quality,
utility, and clarity of the information being collected; and (4) ways
for FRA to minimize the burden of information collection activities on
the public, including the use of automated collection techniques or
other forms of information technology. See 44 U.S.C. 3506(c)(2)(A); 5
CFR 1320.8(d)(1).
    FRA believes that soliciting public comment may reduce the
administrative and paperwork burdens associated with the collection of
information that Federal regulations mandate. In summary, FRA reasons
that comments received will advance three objectives: (1) Reduce
reporting burdens; (2) organize information collection requirements in
a ``user-friendly'' format to improve the use of such information; and
(3) accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    The summaries below describe the ICRs that FRA will submit for OMB
clearance as the PRA requires:
    Title: Certification of Glazing Materials.
    OMB Control Number: 2130-0525.
    Abstract: The collection of information is set forth under 49 CFR
part 223, which requires the certification and permanent marking of
glazing materials by the manufacturer. The manufacturer is also
responsible for making available test verification data to railroads
and to FRA upon request.
    Type of Request: Extension without change (with changes in
estimates) of a currently approved collection.
    Affected Public: Businesses (railroads and manufacturers of glazing
materials).
    Form(s): N/A.
    Respondent Universe: 704 railroads and 5 manufacturers.
    Frequency of Submission: On occasion.
    Reporting Burden:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average time  per      Total annual burden     Total cost
          CFR section \1\                Respondent  universe     Total annual responses         response                  hours            equivalent
                                     ...........................  (A)...................  (B)...................  (C) = A * B...........  (D) = C * wage
                                                                                rate \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
223.3(c)--Application--Locomotives,  704 railroads..............  400 marked tools        30 minutes............  200.00 hours..........      $11,978.00
 passenger cars, and cabooses less                                 (small hammers with
 than 50 years old and not used                                    instructions).
 exclusively for excursion,
 educational, recreational, or
 private transportation purposes.
223.11(c)--Requirements for          704 railroads..............  10 renewal waivers....  4 hours...............  40.00 hours...........        4,609.60
 existing locomotives built or
 rebuilt prior to July 1, 1980,
 equipped with certified glazing in
 all locomotive cab windows.
    --(d)(1) Locomotive placed in    704 railroads..............  15 stencilings........  3 minutes.............  .75 hour..............           44.92
     designated service due to a
     damaged or broken cab window--
     Stenciled ``Designated
     Service--DO NOT OCCUPY''.
                                    --------------------------------------------------------------------------------------------------------------------
    --(d)(2) Locomotives removed      Glazing certification for locomotive replacement windows is done at the time of manufacturing. Consequently, there
     from service until broken or                                  is no additional burden associated with this requirement.
     damaged windows are replaced
     with certified glazing.
                                    --------------------------------------------------------------------------------------------------------------------
223.13(c)--Requirements for          704 railroads..............  2 renewal waivers.....  4 hours...............  8.00 hours............          921.92
 existing cabooses built or rebuilt
 prior to July 1, 1980, equipped
 with certified glazing in all
 windows.
                                    --------------------------------------------------------------------------------------------------------------------
    --(d) Cabooses removed from       Glazing certification for caboose replacement windows is done at the time of manufacturing. Consequently, there is
     service until broken or                                        no additional burden associated with this requirement.
     damaged windows are replaced
     with certified glazing.
                                    --------------------------------------------------------------------------------------------------------------------
223.15(c)--Requirements for          704 railroads..............  2 renewal waivers.....  4 hours...............  8 hours...............             922
 existing passenger cars built or
 rebuilt prior to July 1, 1980,
 equipped with certified glazing in
 all windows plus four emergency
 windows.
                                    --------------------------------------------------------------------------------------------------------------------
    --(d) Passenger cars removed       Glazing certification for passenger car replacement windows is done at the time of manufacturing. Consequently,
     from service until broken/                                 there is no additional burden associated with this requirement.
     damaged windows are replaced
     with certified glazing.
                                    --------------------------------------------------------------------------------------------------------------------
Appendix A--(b)(16)--Certification   5 manufacturers............  10 certifications.....  30 minutes............  5.00 hours............          387.20
 of glazing materials--
 Manufacturers to certify in
 writing that glazing material
 meets the requirements of this
 section.
    --(c) Identification and         5 manufacturers............  25,000 marked pieces..  480 pieces per hour...  52.08 hours...........        3,119.07
     marking of each unit of
     glazing material.
                                    --------------------------------------------------------------------------------------------------------------------

        Total......................  704 railroads + 5            25,439 responses......  N/A...................  314 hours.............          21,983
                                      manufacturers.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Estimated Annual Responses: 25,439.
---------------------------------------------------------------------------

    \1\ The current inventory exhibits a total burden of 269 hours
while the total burden of this notice is 314 hours. As part of its
review of this ICR renewal, FRA determined some of the previous
estimates were outdated.
    \2\ Throughout this notice, the dollar equivalent cost is
derived from the Surface Transportation Board's 2020 Full Year Wage
A&B data series using the appropriate employee group hourly wage
rate that includes a 75-percent overhead charge.
---------------------------------------------------------------------------

    Total Estimated Annual Burden: 314 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent: $21,983.
    Title: Disqualification Proceedings.
    OMB Control Number: 2130-0529.
    Abstract: FRA regulations at 49 CFR part 209, subpart D, explain
FRA's responsibilities, and the rights and responsibilities of
railroads and railroad employees, regarding disqualification
procedures. For example, Sec.  209.331, enforcement of a
disqualification order, requires: (a) A railroad employing or formerly
employing a disqualified individual to disclose the terms and
conditions of the order to the individual's new or prospective employer
railroad; (b) a railroad considering hiring an individual in a safety-
sensitive position to inquire from the individual's prior employer
railroad whether the individual is serving under a disqualification
order; and (c) a disqualified individual to inform the individual's
employer of the disqualification order, provide a copy of the order to
the employer, inform a prospective employer railroad of the
disqualification order, and provide a copy of the order.
    Type of Request: Extension without change (with changes in
estimates) of a currently approved collection.
    Affected Public: Businesses.
    Form(s): N/A.
    Respondent Universe: 86,000 railroad employees and 754 railroads.
    Frequency of Submission: On occasion.
    Reporting Burden:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Total annual        Average time  per     Total annual burden     Total cost
          CFR section \3\                 Respondent universe              responses               response                hours            equivalent
                                    ...............................  (A)..................  (B)..................  (C) = A * B..........  (D) = C * wage
                                                                                rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
209.307(a)--Reply--Within 30 days   86,000 employees...............  12 replies...........  3 hours..............  36.00 hours..........       $2,224.44
 after receipt of the notice of
 proposed disqualification issued
 under Sec.   209.305, the
 respondent shall reply in writing
 to the charges.
    --(b) Reply--Request for an     86,000 employees...............  2 requests...........  30 minutes...........  1.00 hour............           61.79
     extension.
                                   ---------------------------------------------------------------------------------------------------------------------
209.309(a)-(b)--Informal response        The estimated paperwork burden associated with this regulatory requirement is covered under Sec.   209.307.
 by railroad employee to a notice
 of proposed disqualification.
                                   ---------------------------------------------------------------------------------------------------------------------
    --(h) Informal response--       86,000 employees...............  4 requests...........  30 minutes...........  2.00 hours...........          123.58
     Request for an extension.
209.331(a)--Enforcement of          754 railroads..................  1 notification letter  30 minutes + 30        1 hour...............           77.44
 disqualification order--A                                            + 1 information        minutes.
 railroad that employs or formerly                                    letter.
 employed an individual serving
 under a disqualification order
 must inform other prospective
 employers.
                                   ---------------------------------------------------------------------------------------------------------------------
    --(b) Enforcement of               This is a common practice for the railroad industry to do routine personnel checks on individuals whom they are
     disqualification order--                           planning on hiring. Thus, there is no burden associated with this requirement.
     Personnel background check.
                                   ---------------------------------------------------------------------------------------------------------------------
    --(c) Enforcement of            86,000 employees...............  1 disqualification     30 minutes + 30        1 hour...............           61.79
     disqualification order--                                         letter + 1 copy of     minutes.
     Individual subject to                                            disqualification
     disqualification order to                                        letter.
     inform employer and provide
     copy to employer within 5
     days after receipt of such
     order.
                                   ---------------------------------------------------------------------------------------------------------------------
        Total.....................  86,000 employees + 754           22 responses.........  N/A..................  41.00 hours..........           2,549
                                     railroads.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Estimated Annual Responses: 22.
---------------------------------------------------------------------------

    \3\ The current inventory exhibits a total burden of 5 hours
while the total burden of this notice is 41 hours. As part of its
review of this ICR renewal, FRA determined some of the previous
estimates were outdated. Additionally, the requirements under
Sec. Sec.  209.311 through 209.327 are exempted from the PRA under 5
CFR 1320.4(a)(2). Since these provisions pertain to an
administrative action or investigation, there is no PRA burden
associated with these requirements.
---------------------------------------------------------------------------

    Total Estimated Annual Burden: 41 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent: $2,549.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that a respondent is not required to
respond to, conduct, or sponsor a collection of information that does
not display a currently valid OMB control number.
    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Deputy Chief Counsel.
[FR Doc. 2022-02108 Filed 2-1-22; 8:45 am]
BILLING CODE 4910-06-P