[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Rules and Regulations]
[Pages 59570-59575]
[FR Doc No: 2015-24677]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0128; Directorate Identifier 2013-NM-133-AD;
Amendment 39-18278; AD 2015-19-16]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for The
Boeing Company Model 777 airplanes equipped with Rolls-Royce Trent 800
series engines. This AD was prompted by reports of in-flight separation
of the engine's aft plug from the forward plug, which are the two parts
of the turbine exhaust plug assembly. This AD requires installation of
a serviceable turbine exhaust plug assembly (for certain airplanes),
and a general visual inspection (for certain airplanes) to determine
the diameter of the bolt used at the forward and aft plug interface,
and applicable corrective actions. We are issuing this AD to prevent
separation of the aft plug from the forward plug of the turbine exhaust
plug assembly, which could result in parts departing the airplane and
hitting the empennage, and destabilizing the airplane during a critical
flight phase. In addition, parts remaining on a runway could pose a
hazard to another airplane.

DATES: This AD is effective November 6, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 6,
2015.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced 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<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0128.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0128; or in person at the Docket Management Facility 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 address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kevin Nguyen, Aerospace Engineer,
Propulsion Branch, ANM-140S, Seattle Aircraft Certification Office
(ACO), FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-
917-6501; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to The Boeing Company Model
777 airplanes equipped with Rolls-Royce Trent 800 series engines. The
NPRM published in the Federal Register on March 3, 2014 (79 FR 11725);
corrected March 11, 2014 (79 FR 13592). The NPRM was prompted by
reports of in-flight separation of the engine's aft plug from the
forward plug, which are the two parts of the turbine exhaust plug
assembly. The NPRM proposed to require installation of a serviceable
turbine exhaust plug assembly (for certain airplanes), and a general
visual inspection (for certain airplanes) to determine the diameter of
the bolt used at the forward and aft plug interface, and applicable
corrective actions. We are issuing this AD to prevent separation of the
aft plug from the forward plug of the turbine exhaust plug assembly,
which could result in parts departing the airplane and hitting the
empennage, and destabilizing the airplane during a critical flight
phase. In addition, parts remaining on a runway could pose a hazard to
another airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM (79
FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592); and
the FAA's response to each comment.

Request To Match Compliance Time

    Cathay Pacific requested that we ensure that the AD compliance date
will be the same as the compliance time of Boeing Special Attention
Service Bulletin 777-78-0051, Revision 3, dated August 23, 2012; or
Boeing Special Attention Service Bulletin 777-78-0051, Revision 4,
dated February 7, 2014. Cathay Pacific reasoned that paragraph (i) of
the proposed AD specified compliance within 60 months after the
effective date of the proposed AD, and both revisions of this service
information specify a compliance time that is within 60 months after
the Revision 3 date of the service bulletin.
    We infer that Cathay Pacific is requesting that we reduce the
compliance time of this final rule to match the compliance time listed
in the service information. We do not agree with the commenter's
request. In developing an appropriate compliance time for this action,
we considered not only the degree of urgency associated with addressing
the subject unsafe condition, but the manufacturer's recommendation for
an appropriate compliance time, the time required for the rulemaking
process, the availability of required parts, and the practical aspect
of installing the required modification within an interval of time that
corresponds to the typical scheduled maintenance for the majority of
affected operators. Under the provisions of paragraph (l) of this AD,

we may approve requests for adjustments to the compliance time, if data
are submitted to substantiate that such an adjustment would provide an
acceptable level of safety. We have not changed the AD in this regard.

Request To Define ``Serviceable'' To Include Pre-Boeing Service
Bulletin 777-78-0051 Plug Assemblies

    Cathay Pacific requested that we revise paragraph (j) of the
proposed AD; corrected March 11, 2014 (79 FR 13592) to define
``serviceable'' plug assemblies. Cathay Pacific reasoned that both pre-
and post-Boeing Service Bulletin 777-78-0051 plug assemblies can be
installed, and the modification can be completed before the required
compliance time of the NPRM (79 FR 11725, March 3, 2014; corrected
March 11, 2014 (79 FR 13592)).
    We do not agree to revise paragraph (j) of this AD because
serviceable assemblies are already defined in paragraph (h) of this AD.
This definition applies to the entire AD. Also, pre- Boeing Service
Bulletin 777-78-0051 plug assemblies do not meet the definition of
serviceable, as specified in the service information.

Request To Revise Definition of a Serviceable Assembly

    American Airlines (AA) requested that we revise paragraph (h) of
the proposed AD to add another definition: Serviceable plug assemblies,
as those maintained in accordance with the operator's continued
airworthiness maintenance program (CAMP), prior to issuance of Boeing
Special Attention Service Bulletin 777-78-0051, Revision 3, dated
August 23, 2012. AA explained that prior to release of Boeing Special
Attention Service Bulletin 777-78-0051, Revision 3, dated August 23,
2012, due to reported events of exhaust plug losses by other operators,
AA recognized that multiple removals of the exhaust aft plug causes the
3/16'' nutplate locking feature to wear out, which could then result in
loss of the aft plug. As a result, AA implemented a maintenance program
as part of its CAMP, which offers a level of safety equivalent to that
of Boeing Special Attention Service Bulletin 777-78-0051, Revision 3,
dated August 23, 2012. During every engine removal, for a refurbishment
or overhaul shop visit, the pre-Boeing Special Attention Service
Bulletin 777-78-0051, Revision 3, dated August 23, 2012, exhaust aft
plug nutplates are replaced with new nutplates.
    In addition, AA stated that the holes are inspected for elongation
and cracks in accordance with procedures equivalent to Boeing Special
Attention Service Bulletin 777-78-0051 inspection procedures. Model 777
Airplane Maintenance Manual Chapter 78-11-02-400-803-R00, requires that
the minimum fastener run[hyphen]on torque of 2 in[hyphen]lbs is met
during every installation of the aft exhaust plug. In addition, each of
the exhaust aft plug fasteners receives a general visual check, using a
ladder/stand and a bright light, every 150 flight hours. AA expressed
that it is currently the largest Model 777-200 Trent 800 operator in
the worldwide fleet and has not lost an exhaust aft plug due to loose
or missing fasteners, as its CAMP demonstrates an equivalent level of
safety to the service information.
    As an alternative, AA requested that we revise the NPRM (79 FR
11725, March 3, 2014; corrected March 11, 2014 (79 FR 13592)) to
include, as serviceable exhaust aft plugs, those maintained in
accordance with the operator's own maintenance program, such as AA's
approved CAMP prior to issuance of Boeing Special Attention Service
Bulletin 777-78-0051, Revision 3, dated August 23, 2012, and to remain
in service until the next engine removal for refurbishment or overhaul
shop visit, or 60 months from the effective date of the AD, whichever
is later.
    We do not agree to include the requested provision. The maintenance
program described by AA is likely to be acceptable in lieu of direct
compliance with portions of this AD; however, the description of that
program provided in AA's comment is not sufficient to serve as
engineering data for the FAA to approve as an optional method of
compliance in this AD. Operators can submit a request for approval of
an alternative method of compliance (AMOC), with a more detailed
proposal to use the maintenance program, if sufficient data are
submitted to substantiate that the change would provide an acceptable
level of safety. We have not changed this AD in this regard.

Request To Change Compliance Time of Parts Installation Limitation

    Boeing and Cathay Pacific requested that we revise paragraph (j) of
the proposed AD to change the installation limitation from the
effective date of the AD to the compliance deadline for the AD. Boeing
reasoned that paragraph (j) of the proposed AD currently creates an
alternative and indeterminate compliance deadline. Boeing explained
that during the compliance interval and prior to the AD deadline,
operators may be required, due to unforeseen circumstances, to install
a unit that is not a serviceable unit, and that under the current
wording, this would unnecessarily ground the airplane.
    We do not agree to revise paragraph (j) of this AD to change the
installation limitation from the effective date of the AD to the
compliance date of the AD. Grace period compliance times are provided
in ADs in recognition that an immediate unscheduled modification
requirement would be disruptive. A grace period is included to give
operators a reasonable period of time to schedule and perform actions
that are required by the AD and that otherwise would not have occurred.
A parts installation limitation is included in some cases to require
that, if the parts affected by the AD are already being removed for a
reason other than the AD itself, that opportunity to correct the unsafe
condition should be taken. We determine whether such a parts
installation limitation should be included in the AD, and what the
specific requirements of the limitation will be, based on the risk
level associated with the unsafe condition and the expected
availability of required replacement parts.
    In this case, we made a determination that the risk warranted the
consideration of a parts installation limitation. We also determined
that sufficient parts would be available to meet that limitation, and
that sufficient time to perform any required actions to make a nozzle
assembly serviceable as defined in paragraph (h) of this AD would exist
in situations where the nozzle might be removed in maintenance.
Specifically, we considered the case of an unscheduled engine change
where an operator may not have included a serviceable nozzle assembly
with the replacement engine. Modification of a nozzle assembly to meet
the definition of a serviceable nozzle can be performed in roughly the
same or less elapsed time than it takes to perform the engine
replacement itself. We did not foresee any other commonly occurring
situation where an engine nozzle assembly would be removed for
maintenance. However, as discussed in response to the comment issue
``Request to Revise Definition of a Serviceable Assembly,'' if an
operator specifically and adequately addresses the management of this
unsafe condition within its CAMP, we will consider AMOC approvals to
allow installation of nozzle assemblies that do not meet the definition
of serviceable nozzle in paragraph (h) of this AD.
    We clarified paragraph (j) of this AD as a result of these
comments. We considered the explanatory statements about the intent of
the parts installation limitation language used in several

recent ADs, and determined that different language should be used in
this case to more clearly convey the intent of the parts installation
limitation contained in this AD. We have added the words ``or re-
install'' to paragraph (j) to clarify that any installation of a nozzle
assembly, regardless of the reason for the removal of the nozzle
assembly and regardless of the source of the replacement nozzle
assembly, is subject to the parts installation limitation of paragraph
(j) of this AD.

Request To Clarify Paragraph (j) of the Proposed AD

    AA requested that we clarify paragraph (j) of the proposed AD. AA
explained that paragraph (j) of the proposed AD allows that only a
serviceable turbine exhaust plug assembly may be installed on any
airplane as of the effective date of this AD, while paragraph (i) of
the proposed AD requires a compliance time within a certain time after
the effective date of this AD, without any referral to serviceable
turbine exhaust plug assembly. AA reasoned that as written, these steps
are confusing and could lead operators to believe the actions required
by the AD are due as of the effective date of this AD.
    We agree with the commenter and have clarified paragraph (j) of
this AD by including references to paragraphs (h)(1) and (h)(2) of this
AD.

Request To Clarify the AMOC Paragraph

    Boeing requested that we revise paragraph (k)(3) of the proposed AD
(paragraph (l)(3) of this AD) to indicate that an AMOC, approved for a
repaired serviceable unit is to be attached to, and travel with, the
repaired serviceable unit. Boeing explained that the AMOC approval
should apply to the deviation on the serviceable unit and thereby
travel with the serviceable unit, which is rotable and could be
installed on numerous airplanes during its service life. Boeing also
explained that a unit repaired in accordance with an approved AMOC will
fulfill the intent of airplane safety when the unit is installed on an
airplane, and that the unit will be in compliance with the AD as long
as the part is serviceable as defined by the AD.
    We agree with the commenter and have revised paragraph (l)(3) of
this AD accordingly.

Request To Use the CAMP

    AA requested that we revise the NPRM (79 FR 11725, March 3, 2014;
corrected March 11, 2014 (79 FR 13592)), to include language that
allows the optional re-identification of the exhaust plug with the
correct post-Boeing Special Attention Service Bulletin 777-78-0051,
part number identity in accordance with a method approved by the
operator's approved CAMP, as the CAMP provides an equivalent level of
safety. AA explained that prior to the release of Boeing Special
Attention Service Bulletin 777-78-0051, Revision 3, dated August 23,
2012, AA implemented a maintenance program to install data plates on
the forward and aft exhaust plug. The plates were installed because the
manufacturer part number and serial number, which were chemical-etched
on the exhaust plug skin by the manufacturer, were no longer legible.
AA stated that the data plates contain the original part number, a
company-assigned serial number, and the text ``MATCHED SET. DO NOT
SEPARATE.'' AA added that the installed identification plates are in
the same location as, but a different length than, the plates specified
in Boeing Special Attention Service Bulletin 777-78-0051, Revision 3,
dated August 23, 2012.
    We agree to allow alternative permanent part-marking methods. If
the markings contain the required information and are permanent, the
intent of the marking requirement is addressed, and additional
flexibility is provided to operators. Therefore, part-marking methods
for the CAMP might be approved, provided that the markings are
permanent and contain the information specified in Boeing Special
Attention Service Bulletin 777-78-0051, Revision 4, dated February 7,
2014. We have added this information to paragraph (g) of this AD
accordingly.

Request To Eliminate AMOC Approval Requirement for Previous Repairs

    AA requested that we revise paragraph (h) of the proposed AD, to
allow repairs accomplished prior to the release of this AD, in
accordance with Boeing instructions and approved per 14 CFR part
121.379, or a Boeing ODA, to be included as acceptable repairs in this
AD, without the requirement to obtain a Boeing ODA AMOC or Seattle
Aircraft Certification Office AMOC approval.
    AA explained that, prior to release of the NPRM (79 FR 11725, March
3, 2014; corrected March 11, 2014 (79 FR 13592)); exhaust aft plugs
have received repairs at the exhaust aft plug mate line during
inspection or during incorporation of Boeing Special Attention Service
Bulletin 777-78-0051, Revision 3, dated August 23, 2012, utilizing
procedures provided by Boeing without Boeing ODA approval; rather, the
repair was approved per 14 CFR part 121.379. AA expressed that
paragraph (h) of the proposed AD specifies using a repair method
approved in accordance with the procedures specified in paragraph (k)
of the proposed AD, and these previously accomplished repairs, which
followed Boeing repair instructions, offer an equivalent level of
safety to the NPRM.
    We partially agree with the request. We agree to add paragraph
(l)(4) in this AD to eliminate the requirement for subsequent AMOC
approval for repairs that were previously approved by the Boeing ODA,
using an FAA Form 8100-9, and having met the requirements of paragraph
(h) of this AD, for the definition of serviceable turbine exhaust plug
assemblies. We are confident that the Boeing ODA repair approval
process ensures that each repair is reviewed by qualified engineering
staff with knowledge of the original airplane design and compliance
substantiation. At the same time, we want to ensure that those repairs
would have a configuration that meets the definition of serviceable
turbine exhaust plug assemblies as defined in the service information.
We have added paragraph (l)(4) in this AD to state that repairs
approved prior to the effective date of this AD, by the Boeing ODA
using FAA Form 8100-9, and having met the requirements of paragraph (h)
of this AD for the definition of serviceable turbine exhaust plug
assemblies, do not require AMOC approval.
    We disagree, however, to eliminate the AMOC approval requirement
for repairs approved by other means. Even though Boeing Service
Engineering may have provided a ``no technical objection'' statement,
qualified engineering staff with knowledge of the original airplane
design and compliance substantiation may not have been involved in
evaluating the repair. We have not changed this AD in this regard.

Additional Changes to This AD

    We have revised this AD to refer to Boeing Special Attention
Service Bulletin 777-78-0051, Revision 4, dated February 7, 2014, as
the appropriate source of service information for the required actions.
Among other things, this service information adds Group 2 airplanes to
paragraph 1.E., ``Compliance;'' includes a maintenance records check;
adds a general visual inspection to determine the diameter of the bolt
used at the forward and aft plug interface; and adds applicable
corrective actions--all of which we have clarified in new paragraph
(g)(4) of this AD. Paragraphs (g)(3) and (c) of the proposed AD already
accounted for the Group 2

airplanes defined in Boeing Special Attention Service Bulletin 777-78-
0051, Revision 4, dated February 7, 2014. Paragraph (g)(2) of the
proposed AD accounted for the required actions.
    We have also added a new paragraph (k) to this AD to provide credit
for certain actions, if those actions were performed before the
effective date of this AD using Boeing Special Attention Service
Bulletin 777-78-0051, Revision 3, dated August 23, 2012. We have
redesignated the subsequent paragraphs of this AD accordingly.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 11725, March 3, 2014; corrected March 11, 2014 (79 FR
13592)) for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 11725, March 3, 2014; corrected
March 11, 2014 (79 FR 13592)).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Special Attention Service Bulletin 777-78-0051,
Revision 4, dated February 7, 2014. Among other things, this service
information adds Group 2 airplanes to paragraph 1.E., ``Compliance;''
includes a maintenance records check; adds a general visual inspection
to determine the diameter of the bolt used at the forward and aft plug
interface; and adds applicable corrective actions. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section of this AD.

Costs of Compliance

    We estimate that this AD affects 35 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
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Installation..........................  5 work-hours x $85 per                $0            $425         $14,875
                                         hour = $425.
General visual inspection.............  2 work-hours x $85 per                $0            $170          $5,950
                                         hour = $170.
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    We estimate the following costs to do any necessary replacement
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need this
replacement:

                                               On-Condition Costs
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                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement (replacing the \3/16\-inch bolts   5 work-hours x $85 per hour =                $0             $425
 with \1/4\-inch bolts).                        $425.
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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

    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 DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2015-19-16 The Boeing Company: Amendment 39-18278; Docket No. FAA-
2014-0128; Directorate Identifier 2013-NM-133-AD.

(a) Effective Date

    This AD is effective November 6, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300,-300ER, and 777F series airplanes; certificated in any category;
equipped with Rolls-Royce Trent 800 series engines.

(d) Subject

    Air Transport Association (ATA) of America Code 78, Engine
Exhaust.

(e) Unsafe Condition

    This AD was prompted by reports of in-flight separation of the
engine's aft plug from the forward plug, which are the two parts of
the turbine exhaust plug assembly. We are issuing this AD to prevent
separation of the aft plug from the forward plug of the turbine
exhaust plug assembly, which could result in parts departing the
airplane and hitting the empennage or hitting a person on the
ground, and destabilizing the airplane during a critical flight
phase; parts remaining on a runway could cause damage to another
airplane.

(f) Compliance

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

(g) Installation and General Visual Inspection

    At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Special Attention Service Bulletin 777-78-
0051, Revision 4, dated February 7, 2014, except as provided by
paragraph (i) of this AD, do the applicable actions specified in
paragraphs (g)(1), (g)(2), (g)(3), and (g)(4) of this AD, in
accordance with the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 777-78-0051, Revision 4, dated February
7, 2014. Alternative part marking methods are allowed for the
requirements of this paragraph, if approved by the FAA principal
maintenance inspector, provided that the markings are permanent and
contain the information required by Boeing Special Attention Service
Bulletin 777-78-0051, Revision 4, dated February 7, 2014.
    (1) For airplanes identified as Group 1, Configuration 1, in
Boeing Special Attention Service Bulletin 777-78-0051, Revision 4,
dated February 7, 2014: Install a serviceable turbine exhaust plug
assembly.
    (2) For airplanes identified as Group 1, Configurations 2 and 3,
in Boeing Special Attention Service Bulletin 777-78-0051, Revision
4, dated February 7, 2014: Do a general visual inspection to
determine the diameter of the bolt used at the forward and aft plug
interface, and before further flight, do all applicable corrective
actions.
    (3) For airplanes listed in paragraph (c) of this AD that are
not listed in the ``Effectivity'' section of Boeing Special
Attention Service Bulletin 777-78-0051, Revision 4, dated February
7, 2014: Do a general visual inspection to determine if a
serviceable turbine exhaust plug assembly is installed. If a
serviceable turbine exhaust plug assembly is not installed, before
further flight, install a serviceable turbine exhaust plug assembly.
    (4) For airplanes identified as Group 2, in Boeing Special
Attention Service Bulletin 777-78-0051, Revision 4, dated February
7, 2014: Do a maintenance records check to determine affected
turbine exhaust plug assemblies, and for affected assemblies, do a
general visual inspection to determine the diameter of the bolt used
at the forward and aft plug interface, and before further flight, do
all applicable corrective actions.

(h) Definition of Serviceable Assembly

    For the purposes of this AD, an acceptable serviceable turbine
exhaust plug assembly must meet the conditions specified in
paragraph (h)(1) or (h)(2) of this AD.
    (1) A new assembly with part number 314W5520-22.
    (2) A serviceable assembly as defined in the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 777-78-
0051, Revision 4, dated February 7, 2014; except, for any assembly
on which the actions specified in Part 2 or Part 3 of the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 777-78-0051, Revision 4, dated February 7, 2014, are done,
and Boeing Special Attention Service Bulletin 777-78-0051, Revision
4, dated February 7, 2014, specifies to contact Boeing for repair
instructions, this AD requires repair before further flight, using a
method approved in accordance with the procedures specified in
paragraph (l)(1) of this AD.

(i) Exception to Service Information Specifications

    Where paragraph 1.E., ``Compliance,'' of Boeing Special
Attention Service Bulletin 777-78-0051, Revision 4, dated February
7, 2014, specifies a compliance time ``after the Revision 3 date of
this service bulletin,'' or ``after the Revision 4 date of this
service bulletin,'' this AD requires compliance within the
applicable time after the effective date of this AD.

(j) Parts Installation Limitation

    As of the effective date of this AD, only a serviceable turbine
exhaust plug assembly that meets the requirements of paragraph
(h)(1) or (h)(2) of this AD may be installed or reinstalled on any
airplane.

(k) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Boeing Special Attention Service
Bulletin 777-78-0051, Revision 3, dated August 23, 2012 (which is
not incorporated by reference in this AD), provided that for Group
1, Configuration 2, airplanes, on which the condition defined in
Table 2 of paragraph 1.E., ``Compliance,'' of Boeing Special
Attention Service Bulletin 777-78-0051, Revision 3, dated August 23,
2012, was found (i.e., only \1/4\ inch diameter bolts are found
installed at all 33 locations forward and aft plug interface), the
re-identification of the forward and aft plug was done before
further flight after the inspection.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
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 manager of the ACO, send it to the
attention of the person identified in paragraph (m) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD. An AMOC approved as described in this
paragraph for a specific serviceable nozzle assembly may be
transferred with that nozzle assembly to another aircraft without an
additional AMOC approval being required.
    (4) Repairs approved prior to the effective date of this AD by
the Boeing ODA do not require AMOC approval if those repairs were
approved using FAA Form 8100-9 and those repairs meet the definition
of a serviceable assembly contained in the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 777-78-
0051, Revision 4, dated February 7, 2014.

(m) Related Information

    (1) For more information about this AD, contact Kevin Nguyen,
Aerospace Engineer, Propulsion Branch, ANM-140S, Seattle Aircraft
Certification Office (ACO) FAA, 1601 Lind Avenue SW., Renton, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (n)(3) and (n)(4) of this AD.

(n) 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 the AD specifies otherwise.
    (i) Boeing Special Attention Service Bulletin 777-78-0051,
Revision 4, dated February 7, 2014.
    (ii) Reserved.
    (3) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207;
telephone

206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at 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.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 16, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-24677 Filed 10-1-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25663-25664]
[FR Doc No: 2016-10157]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-1410-000]

Torofino Trading LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Torofino Trading LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 11, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.

    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: April 21, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-10157 Filed 4-28-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36073-36074]
[FR Doc No: 2014-14766]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0010]

Cooperative Agreement to Support the World Trade Organization's
Standards and Trade Development Facility

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to receive and consider a single source application for the
award of a cooperative agreement in fiscal year 2014 (FY14) to the
World Trade Organization's (WTO) Standards and Trade Development
Facility (STDF).

DATES: Important dates are as follows:

1. The application due date is July 23, 2014.
2. The anticipated start date is September 2014.
3. The opening date is June 23, 2014.
4. The expiration date is July 24, 2014.

ADDRESSES: Submit electronic applications to: http://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.

FOR FURTHER INFORMATION CONTACT: Scientific/Programmatic Contact: Julie
Moss, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy. (HFS-550), College Park, MD
20740,<PHONE_NUMBER>, email<EMAIL_ADDRESS>    Grants Management Contact: Kimberly Pendleton Chew, Office of
Acquisitions and Grant Services, Food and Drug Administration, 5630
Fishers Lane, rm. 2031, Rockville, MD 20857,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://www.fda.gov/food/newsevents/default.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-14-087
93.103

A. Background

    The STDF is a unique global partnership established by the Food and
Agriculture Organization, World Organization for Animal Health, World
Bank, World Health Organization (WHO) and the WTO. The STDF supports
developing countries in building their capacity to implement
international sanitary and phytosanitary (SPS) standards, guidelines,
and recommendations as a means to improve their human, animal, and
plant health status and ability to gain or maintain access to markets.
In achieving its aims, the STDF acts as both a coordinating and a
financing mechanism.
    The STDF is a widely established knowledge platform for information
exchange, sharing experiences, and the identification and dissemination
of good practice on SPS-related technical cooperation. Since 2004, over
60 projects and 52 project preparation grants have assisted developing
countries to overcome SPS constraints, and gain and maintain market
access. Over 50 percent have benefited least developed and other low-
income countries.
    The STDF utilizes a key decision support tool, Multi-Criteria
Decision Analysis (MCDA), to help establish SPS priorities and ensure
resources are used as efficiently as possible. The use of the MCDA tool
is unique within the STDF and is a highly valued attribute; the MCDA
tool facilitates an open and transparent discussion among public and
private stakeholders about capacity building needs and resources. The
STDF is committed to the Paris Principles on Aid Effectiveness and to
achieving the Millennium Development Goals.
    With an increasingly diverse and complex global food supply, FDA's
interest is to strengthen food safety systems globally to prevent food
safety problems rather than merely reacting to problems after they
occur. FDA recognizes that it cannot do this alone. By leveraging with
other WTO member countries and partnering with the STDF, FDA can
broaden the reach of food safety capacity building efforts.
    This cooperative agreement will allow FDA to deepen its
international food safety capacity building partnerships, provide a
wider scope of impact than exists currently, and leverage resources
with other countries.

B. Research Objectives

    The purpose of this cooperative agreement is to:
     Contribute to the knowledge base and development of food
safety systems globally due to the increasingly diverse and complex
food supply;
     Enhance and broaden FDA's ability to address global food
safety and public health issues associated with food;
     Provide opportunities to leverage additional resources
among WTO member countries;
     Support FDA's Food Safety Modernization Act (Pub. L. 111-
353) and its International Food Safety Capacity Building Plan, which
emphasizes the concept of preventing food safety related problems
before they occur, and the importance of establishing strong
relationships and mutual support among all stakeholders, including
multilateral organizations, to improve worldwide food safety.

C. Eligibility Information

    Competition is limited to the STDF hosted by the WTO. The STDF is a
global partnership with a well-established, trusted presence and is
uniquely qualified to further the global food safety capacity building
objectives of this cooperative agreement. STDF's mandate is to: (1)
Increase awareness, mobilize resources, strengthen collaboration,
identify and disseminate good practice and (2) provide support and
funding for the development and implementation of projects that promote
compliance with international SPS requirements.
    An independent external evaluation of the STDF in 2008 concluded
that the STDF ``carries out an important role that no other single body
would be able to accomplish.'' (Source: STDF Newsletter, Vol. 2, Issue
1, February 2009, accessible at: http://www.standardsfacility.org).
    As such, the STDF is uniquely equipped to fulfill the objectives of
this cooperative agreement due to its diverse access to WTO members in
both developed and developing countries, and its ability to coordinate
capacity building programs at a national and global level. Engaging the
STDF through this cooperative agreement will provide FDA with ample
opportunities to leverage additional resources among WTO member
countries. Overall, the objectives of the STDF are directly in line
with the objectives of this cooperative agreement. This ability to
advance the objectives of this cooperative agreement through member
country engagement and leveraging is a requisite for success.

II. Award Information/Funds Available

A. Award Amount

    The Center for Food Safety and Applied Nutrition intends to fund
one award up to $200,000 total costs (direct plus indirect costs) for
FY 2014. Future year amounts will depend on annual appropriations and
successful performance.

B. Length of Support

    The award will provide 1 year of support and include future
recommended support for four additional years, contingent upon
satisfactory performance in the achievement of project and program
reporting objectives during the preceding year and the availability of
Federal fiscal year appropriations.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at http://www.fda.gov/food/newsevents/default.htm. (FDA has verified the Web site addresses
throughout this document, but FDA is not responsible for any subsequent
changes to the Web sites after this document publishes in the Federal
Register.) For all electronically submitted applications, the following
steps are required.

 Step 1: Obtain a Dun and Bradstreet (DUNS) Number
 Step 2: Register With System for Award Management (SAM)
 Step 3: Obtain Username & Password
 Step 4: Authorized Organization Representative (AOR)
Authorization
 Step 5: Track AOR Status
 Step 6: Register With Electronic Research Administration (eRA)
Commons

    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov.

    Dated: June 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14766 Filed 6-24-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55255]
[DOCID:fr28se07-128]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213

Extension: Form F-4; OMB Control No. 3235-0325; SEC File No. 270-
288.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form F-4 (17 CFR 239.34) is used by foreign issuers to register
securities in business combinations, reorganizations and exchange
offers pursuant to the Securities Act of 1933 (15 U.S.C. 77a et seq.).
The information collected is intended to ensure that the information
required to be filed by the Commission permits verification of
compliance with securities law requirements and assures the public
availability of such information. Form F-4 takes approximately 1,447
hours per response and is filed by approximately 68 respondents. We
estimate that 25% of the 1,447 hours per response (361.75 hours) is
prepared by the registrant for a total annual reporting burden of
24,599 hours (361.75 hours per response x 68 responses). The remaining
75% of the burden hours is attributed to outside cost.
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312;
or send an e-mail to<EMAIL_ADDRESS>
    Dated: September 24, 2007.
Nancy M. Morris,
Secretary.
 [FR Doc. E7-19185 Filed 9-27-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 116 (Thursday, June 16, 2011)]
[Notices]
[Pages 35228-35229]
[FR Doc No: 2011-14924]

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

Coast Guard

[USCG-2011-0494]

Information Collection Request to Office of Management and Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of
revisions to the following collection of information: 1625-0009, Oil
Record Book for Ships. Our ICR describes the information we seek to
collect from the public. Before submitting this ICR to OIRA, the Coast
Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before August 15,
2011.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2011-0494] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT). To avoid duplicate
submissions, please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: DMF (M-30), DOT, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, to attention Desk Officer for the Coast
Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at

room W12-140 on the West Building Ground Floor, 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at  http://www.regulations.gov.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-611), ATTN: Paperwork Reduction Act Manager, US Coast
Guard, 2100 2nd Street, SW., Stop 7101, Washington, DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Ms. Kenlinishia Tyler, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek approval of
revisions of the Collection. We will consider all comments and material
received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2011-0494], and
must be received by August 15, 2011. We will post all comments
received, without change, to http://www.regulations.gov. They will
include any personal information you provide. We have an agreement with
DOT to use their DMF. Please see the ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2011-0494], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
DMF. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
    You may submit your comments and material by electronic means,
mail, fax, or hand delivery to the DMF at the address under ADDRESSES;
but please submit them by only one means. To submit your comment
online, go to http://www.regulations.gov, and type ``USCG-2011-0494''
in the ``Keyword'' box. If you submit your comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\ by 11
inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the Facility,
please enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this Notice as
being available in the docket, go to http://www.regulations.gov, click
on the ``read comments'' box, which will then become highlighted in
blue. In the ``Keyword'' box insert ``USCG-2011-0494'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the DMF in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Request

    Title: Oil Record Book for Ships.
    OMB Control Number: 1625-0009.
    Summary: The Act to Prevent Pollution from Ships (APPS) and the
International Convention for Prevention of Pollution from Ships, 1973,
as modified by the 1978 Protocol relating thereto (MARPOL 73/78),
requires that information about oil cargo or fuel operations be entered
into an Oil Record Book (CG-4602A). The requirement is contained in 33
CFR 151.25.
    Need: This information is used to verify sightings of actual
violations of the APPS to determine the level of compliance with MARPOL
73/78 and as a means of reinforcing the discharge provisions.
    Forms: CG-4602A.
    Respondents: Operators of vessels.
    Frequency: On occasion.
    Burden Estimate: The estimated burden has increased from 19,425
hours to 20,221 hours a year.

    Dated: June 9, 2011.
C.A. Mathieu,
Captain, U.S. Coast Guard, Acting Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2011-14924 Filed 6-15-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Notices]
[Page 47807]
[FR Doc No: 2013-18899]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70085; File Nos. SR-NYSE-2011-55; SR-NYSEAmex-2011-84]

Self-Regulatory Organizations; New York Stock Exchange LLC; NYSE
MKT LLC; Order Granting an Extension to Limited Exemptions From Rule
612(c) of Regulation NMS In Connection With the Exchanges' Retail
Liquidity Programs

July 31, 2013.
    On July 3, 2012, the Commission issued an order pursuant to its
authority under Rule 612(c) of Regulation NMS (``Sub-Penny Rule'') \1\
that granted the New York Stock Exchange LLC (``NYSE'' or ``Exchange'')
and NYSE MKT LLC \2\ (``NYSE MKT'' and, together with NYSE, the
``Exchanges'') limited exemptions from the Sub-Penny Rule in connection
with the operation of each Exchange's Retail Liquidity Program
(``Programs'').\3\ The limited exemptions were granted concurrently
with the Commission's approval of the Exchanges' proposals to adopt
their respective Retail Liquidity Programs for one-year pilot terms.\4\
The exemptions were granted coterminous with the effectiveness of the
pilot Programs; both the pilot Programs and exemptions are scheduled to
expire on July 31, 2013.
---------------------------------------------------------------------------

    \1\ 17 CFR 242.612(c).
    \2\ At the time it filed the original proposal to adopt the
Retail Liquidity Program, NYSE MKT went by the name NYSE Amex LLC.
On May 14, 2012, the Exchange filed a proposed rule change,
immediately effective upon filing, to change its name from NYSE Amex
LLC to NYSE MKT LLC. See Securities Exchange Act Release No. 67037
(May 21, 2012), 77 FR 31415 (May 25, 2012) (SR-NYSEAmex-2012-32).
    \3\ See Securities Exchange Act Release No. 67347, 77 FR 40673
(July 10, 2012) (SR-NYSE-2011-55; SR-NYSEAmex-2011-84) (``Order'').
    \4\ See id.
---------------------------------------------------------------------------

    The Exchanges now seek to extend the exemptions until July 31,
2014.\5\ The Exchanges' request was made in conjunction with
immediately effective filings that extend the operation of the Programs
for one year, until July 31, 2014.\6\ In their request to extend the
exemptions, the Exchanges note that the Programs took some time after
they were adopted to develop and implement fully. Accordingly, the
Exchanges have asked for additional time to allow themselves and the
Commission to analyze more robust data concerning the Programs, which
the Exchanges committed to provide to the Commission.\7\ For this
reason and the reasons stated in the Order originally granting the
limited exemptions, the Commission finds that extending the exemptions,
pursuant to its authority under Rule 612(c) of Regulation NMS, is
appropriate in the public interest and consistent with the protection
of investors.
---------------------------------------------------------------------------

    \5\ See Letter from Janet McGinness, SVP and Corporate
Secretary, NYSE Euronext, to Elizabeth M. Murphy, Secretary,
Securities and Exchange Commission, dated July 30, 2013.
    \6\ See SR-NYSE-2013-48 and SR-NYSEMKT-2013-60.
    \7\ See Order, supra note 3, 77 FR at 40681.
---------------------------------------------------------------------------

    Therefore, it is hereby ordered that, pursuant to Rule 612(c) of
Regulation NMS, each Exchange is granted a one-year extension of the
limited exemption from Rule 612 of Regulation NMS that allows it to
accept and rank orders priced equal to or greater than $1.00 per share
in increments of $0.001, in connection with the operation of its Retail
Liquidity Program.
    The limited and temporary exemptions extended by this Order are
subject to modification or revocation if at any time the Commission
determines that such action is necessary or appropriate in furtherance
of the purposes of the Exchange Act. Responsibility for compliance with
any applicable provisions of the federal securities laws must rest with
the persons relying on the exemptions that are the subject of this
Order.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(83).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-18899 Filed 8-5-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Notices]
[Pages 6428-6430]
[FR Doc No: 2019-03378]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report are used by insurance agents and others to calculate appropriate
flood insurance premium rates for buildings and the contents of those
buildings.

DATES: The date of April 5, 2019 has been established for the FIRM and,
where applicable, the supporting FIS report showing the new or modified
flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at https://msc.fema.gov by the date indicated above.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each

community listed. Notification of these changes has been published in
newspapers of local circulation and 90 days have elapsed since that
publication. The Deputy Associate Administrator for Insurance and
Mitigation has resolved any appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

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

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
             Community                Community map repository address
------------------------------------------------------------------------
           San Mateo County, California and Incorporated Areas
                         Docket No.: FEMA-B-1604
------------------------------------------------------------------------
City of Belmont...................  Public Works Department, One Twin
                                     Pines Lane, Belmont, CA 94002.
City of Brisbane..................  Public Works, 50 Park Place,
                                     Brisbane, CA 94005.
City of Burlingame................  City Hall, 501 Primrose Road,
                                     Burlingame, CA 94010.
City of East Palo Alto............  Community and Economic Development
                                     Department, 1960 Tate Street, East
                                     Palo Alto, CA 94303.
City of Foster City...............  Public Works, 610 Foster City
                                     Boulevard, Foster City, CA 94404.
City of Menlo Park................  City Hall, 701 Laurel Street, Menlo
                                     Park, CA 94025.
City of Millbrae..................  City Hall, 621 Magnolia Avenue,
                                     Millbrae, CA 94030.
City of Redwood City..............  City Hall, 1017 Middlefield Road,
                                     Redwood City, CA 94063.
City of San Bruno.................  City Hall, 567 El Camino Real, San
                                     Bruno, CA 94066.
City of San Carlos................  Building Division, 600 Elm Street,
                                     San Carlos, CA 94070.
City of San Mateo.................  Public Works Department, 330 West
                                     20th Avenue, San Mateo, CA 94403.
City of South San Francisco.......  City Hall, 400 Grand Avenue, South
                                     San Francisco, CA 94080.
Unincorporated Areas of San Mateo   San Mateo County Planning and
 County.                             Building Department, 455 County
                                     Center, Redwood City, CA 94063.
------------------------------------------------------------------------
              Eastland County, Texas and Incorporated Areas
                         Docket No.: FEMA-B-1745
------------------------------------------------------------------------
City of Ranger....................  City Hall, 400 West Main Street,
                                     Ranger, TX 76470.
Unincorporated Areas of Eastland    Eastland County Judge's Office, 100
 County.                             West Main Street, Suite 203,
                                     Eastland, TX 76448.
------------------------------------------------------------------------
               Erath County, Texas and Incorporated Areas
                         Docket No.: FEMA-B-1745
------------------------------------------------------------------------
Unincorporated Areas of Erath       Erath County Courthouse, 100 West
 County.                             Washington Street, Stephenville, TX
                                     76401.
------------------------------------------------------------------------
                Hood County, Texas and Incorporated Areas
                         Docket No.: FEMA-B-1745
------------------------------------------------------------------------
City of DeCordova.................  DeCordova Bend Estates Country Club,
                                     5301 Country Club Drive, Granbury,
                                     TX 76049.
City of Granbury..................  Municipal Service Center, 401 North
                                     Park Street, Granbury, TX 76048.
Unincorporated Areas of Hood        Hood County Environmental Health
 County.                             Department, 201 West Bridge Street,
                                     Granbury, TX 76048.
------------------------------------------------------------------------
              Johnson County, Texas and Incorporated Areas
                         Docket No.: FEMA-B-1745
------------------------------------------------------------------------
Unincorporated Areas of Johnson     Johnson County Public Works
 County.                             Department, Johnson County Annex, 2
                                     North Mill Street, Suite 305,
                                     Cleburne, TX 76033.
------------------------------------------------------------------------
             Palo Pinto County, Texas and Incorporated Areas
                         Docket No.: FEMA-B-1745
------------------------------------------------------------------------
City of Gordon....................  City Hall, 105 South Main Street,
                                     Gordon, TX 76453.
City of Graford...................  City Hall, 424 East Lee Avenue,
                                     Graford, TX 76449.
City of Mineral Wells.............  City Clerk's Office, 115 Southwest
                                     1st Street, Mineral Wells, TX
                                     76067.
City of Mingus....................  City Hall, 229 South Mingus
                                     Boulevard, Mingus, TX 76463.
City of Strawn....................  City Hall, 118 East Housley Street,
                                     Strawn, TX 76475.
Unincorporated Areas of Palo Pinto  Emergency Management Department, 109
 County.                             North Oak Avenue, Mineral Wells, TX
                                     76067.
------------------------------------------------------------------------
               Parker County, Texas and Incorporated Areas
                         Docket No.: FEMA-B-1745
------------------------------------------------------------------------
City of Millsap...................  City Hall, 208 Fannin Street,
                                     Millsap, TX 76066.
City of Mineral Wells.............  City Clerk's Office, 115 Southwest
                                     1st Street, Mineral Wells, TX
                                     76067.

City of Weatherford...............  Utilities Service Center, 917 Eureka
                                     Street, Weatherford, TX 76086.
Town of Cool......................  Cool Community Center, 150 South
                                     Farm to Market Road 113, Millsap,
                                     TX 76066.
Unincorporated Areas of Parker      Parker County Permitting Department,
 County.                             1114 Santa Fe Drive, Weatherford,
                                     TX 76086.
------------------------------------------------------------------------
              Stephens County, Texas and Incorporated Areas
                         Docket No.: FEMA-B-1745
------------------------------------------------------------------------
Unincorporated Areas of Stephens    Stephens County Judge's Office, 200
 County.                             West Walker Street, Breckenridge,
                                     TX 76424.
------------------------------------------------------------------------
               Young County, Texas and Incorporated Areas
                         Docket No.: FEMA-B-1745
------------------------------------------------------------------------
Unincorporated Areas of Young       Young County 911 Director's Office,
 County.                             516 4th Street, Room B5, Graham, TX
                                     76450.
------------------------------------------------------------------------
           Marion County, West Virginia and Incorporated Areas
                         Docket No.: FEMA-B-1763
------------------------------------------------------------------------
City of Fairmont..................  J. Harper Meredith Building, 200
                                     Jackson Street, 3rd Floor--
                                     Planning, Fairmont, WV 26554.
Unincorporated Areas of Marion      Marion County J. Harper Meredith
 County.                             Building, 200 Jackson Street, Room
                                     403 Fairmont, WV 26554.
------------------------------------------------------------------------
         Monongalia County, West Virginia and Incorporated Areas
                         Docket No.: FEMA-B-1763
------------------------------------------------------------------------
City of Morgantown................  City Hall, 389 Spruce Street,
                                     Morgantown, WV 26505.
City of Westover..................  City Hall, 500 Dupont Road,
                                     Westover, WV 26501.
Town of Granville.................  Town Hall, 1245 Main Street,
                                     Granville, WV 26534.
Town of Star City.................  Municipal Building, 370 Broadway
                                     Avenue, Star City, WV 26505.
Unincorporated Areas of Monongalia  Monongalia County Floodplain Permit
 County.                             Office, 243 High Street, Courthouse
                                     Room 110, Morganton, WV 26505.
------------------------------------------------------------------------

[FR Doc. 2019-03378 Filed 2-26-19; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)]
[Notices]
[Pages 30324-30325]
[FR Doc No: 2016-11464]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2016-0010; OMB No. 1660-0017

Agency Information Collection Activities: Proposed Collection;
Comment Request; Public Assistance Program

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on an extension, without change, of a currently approved
information collection. In accordance with the Paperwork Reduction Act
of 1995, this notice seeks comments concerning information collected
for the Public Assistance (PA) program eligibility determinations,
grants management, and compliance with Federal laws and regulations.

DATES: Comments must be submitted on or before July 15, 2016.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2016-0010. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Cliff Brown, Executive Officer,
Recovery Directorate, Public Assistance Division,<PHONE_NUMBER>. You may
contact the Records Management Division for copies of the proposed
collection of information at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act),
authorizes grants to assist State, Tribal, and local governments and
certain Private Non-Profit entities with the response to and recovery
from disasters following Presidentially declared major disasters and
emergencies. 44 CFR part 206 specifies the information collections
necessary to facilitate the provision of assistance under the PA
Program. 44 CFR 206.202 describes the general application procedures
for the PA program.

Collection of Information

    Title: Public Assistance Program.

    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0017.
    FEMA Forms: FEMA Form FEMA Form-009-0-49 Request for Public
Assistance; FEMA Form 009-0-91 Project Worksheet (PW); FEMA Form 009-0-
91A Project Worksheet (PW)--Damage Description and Scope of Work
Continuation Sheet; FEMA Form 009-0-91B Project Worksheet (PW)--Cost
Estimate Continuation Sheet; FEMA Form 009-0-91C Project Worksheet
(PW)--Maps and Sketches Sheet; FEMA Form 009-0-91D Project Worksheet
(PW)--Photo Sheet; FEMA Form 009-0-120 Special Considerations
Questions; FEMA Form 009-0-121 PNP Facility Questionnaire; FEMA Form
009-0-123 Force Account Labor Summary Record; FEMA Form 009-0-124
Materials Summary Record; FEMA Form 009-0-125 Rented Equipment Summary
Record; FEMA Form 009-0-126 Contract Work Summary Record; FEMA Form
009-0-127 Force Account Equipment Summary Record; FEMA Form 009-0-128
Applicant's Benefits Calculation Worksheet; FEMA Form 009-0-111,
Quarterly Progress Reports and FEMA Form 055-0-0-1, Request for
Arbitration resulting from Dispute Resolution Pilot Program.
    Abstract: The information collected is utilized by FEMA to make
determinations for Public Assistance grants based on the information
supplied by the respondents.
    Affected Public: State, Local or Tribal government.
    Number of Respondents: 976.
    Number of Responses: 346,960.
    Estimated Total Annual Burden Hours: 359,186.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $19,625,807. There are no record keeping, capital,
start-up or maintenance costs associated with this information
collection. The cost to the Federal Government is $750,458.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: May 10, 2016.
Richard W. Mattison
Records Management Branch Chief, Mission Support, Federal Emergency
Management Agency, Department of Homeland Security.
[FR Doc. 2016-11464 Filed 5-13-16; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23127-23128]
[FR Doc No: 2017-10198]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Abilene Regional Airport, Abilene, Texas

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release airport property.

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

SUMMARY: The FAA proposes to rule and invite public comment on the
release of land at the Abilene Regional Airport, Abilene, Texas under
the provisions of Section 125 of the Wendell H. Ford Aviation
Investment Reform Act for the 21st Century (AIR 21).

DATES: Comments must be received on or before June 19, 2017.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Mr. Ben Guttery, Manager, Federal
Aviation Administration, Southwest Region, Airports Division, Texas
Airports District Office, ASW-650, 10101 Hillwood Parkway, Fort Worth,
Texas 76177.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mr. Don Green, Director of Transportation
Services, at the following address: Abilene Regional Airport, 2933
Airport Blvd.; Suite 200, Abilene, Texas 77554.

FOR FURTHER INFORMATION CONTACT: Mr. Marcelino Sanchez, Program
Manager, Federal Aviation Administration, Texas Airports District
Office, ASW-650, 10101 Hillwood Parkway, Fort Worth, TX 76177,
Telephone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the Abilene Regional Airport, Abilene,
Texas under the provisions of the AIR 21.
    The following is a brief overview of the request: City of Abilene,
Abilene, Texas requests the release of 51.891 acres of non-aeronautical
airport property. The property is located adjacent to State Highway
Loop 322 and on the west side of the airport. The property to be
released will be sold and revenues shall be used as local matching
funds for future AIP grants, development of common use facilities and
utilities within airport property. Any person may inspect the request
in person at the FAA office listed above under FOR FURTHER INFORMATION
CONTACT.

    In addition, any person may, upon request, inspect the application,
notice and other documents relevant to the application in person at the
Abilene Regional Airport, telephone number<PHONE_NUMBER>.

    Issued in Fort Worth, Texas on May 4, 2017.
Ignacio Flores,
Director, Airports Division.
[FR Doc. 2017-10198 Filed 5-18-17; 8:45 am]
 BILLING CODE P


[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46738-46740]
[FR Doc No: 2018-19989]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0456]

Appropriate Use of Voluntary Consensus Standards in Premarket
Submissions for Medical Devices; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' Voluntary consensus standards can be a valuable resource for
industry and FDA staff because such standards can increase
predictability, streamline premarket review, provide clearer regulatory
expectations, and facilitate market entry for safe and effective
medical products. FDA developed this document to provide guidance to
industry and FDA reviewers about the appropriate use of voluntary
consensus standards in the preparation and evaluation of premarket
submissions for medical devices. This guidance applies to all articles
that meet the definition of a ``device'' under the Federal Food, Drug,
and Cosmetic Act (FD&C Act).

DATES: The announcement of the guidance is published in the Federal
Register on September 14, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0456 for ``Appropriate Use of Voluntary Consensus Standards
in Premarket Submissions for Medical Devices.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.

     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Appropriate Use of Voluntary Consensus Standards in Premarket
Submissions for Medical Devices'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1996, Congress passed the National Technology Transfer and
Advancement Act (NTTAA) (Pub. L. 104-113). The NTTAA codified guidance
previously issued by the Office of Management and Budget (OMB), which
had established a policy to use voluntary consensus standards in lieu
of government-unique standards except where voluntary consensus
standards are inconsistent with law or otherwise impractical. Section
514(c) of the FD&C Act provides FDA the authority to recognize
voluntary consensus standards and accept declarations of conformity to
such standards (see 21 U.S.C. 360d(c)).
    Voluntary consensus standards can be a valuable resource for
industry and FDA staff because such standards can increase
predictability, streamline premarket review, provide clearer regulatory
expectations, and facilitate market entry for safe and effective
medical products. The Agency developed this document to provide
guidance to industry and FDA staff about the appropriate use of
voluntary consensus standards in the preparation and evaluation of
premarket submissions for medical devices. This guidance applies to all
articles that meet the definition of a ``device'' under section 201(h)
of the FD&C Act (21 U.S.C. 321(h)).
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of May 13, 2014 (79 FR 27311). FDA
revised the guidance as appropriate in response to the comments. This
guidance supersedes: (1) ``Guidance for Industry and FDA Staff;
Recognition and Use of Consensus Standards,'' issued on September 17,
2007; (2) ``Frequently Asked Questions on Recognition of Consensus
Standards,'' issued on September 17, 2007; and (3) ``Guidance for
Industry and for FDA Staff: Use of Standards in Substantial Equivalence
Determinations,'' issued on March 12, 2000.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Persons unable to
download an electronic copy of ``Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1770 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in the following FDA regulations,
guidance, and form have been approved by OMB as listed in the following
table:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part. guidance, or FDA form          Topic               No.
------------------------------------------------------------------------
807, subpart E and Form FDA 3654..  Premarket                  0910-0120
                                     Notification.
814, subparts A through E.........  Premarket Approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
``Requests for Feedback on Medical  Q-Submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff``.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice; Quality
                                     System Regulation.
312...............................  Investigational New        0910-0014
                                     Drug Regulation.
601...............................  Biologics License          0910-0338
                                     Application.
------------------------------------------------------------------------

    Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19989 Filed 9-13-18; 8:45 am]
BILLING CODE 4164-01-P