[Federal Register Volume 75, Number 5 (Friday, January 8, 2010)]
[Notices]
[Pages 1060-1062]
[FR Doc No: X10-380108]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0568]

Draft Guidance for Industry on Planning for the Effects of High
Absenteeism to Ensure Availability of Medically Necessary Drug
Products; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Planning for
the Effects of High Absenteeism to Ensure Availability of Medically
Necessary Drug Products.'' The draft guidance encourages manufacturers
of medically necessary drug products (MNPs) and components to develop
contingency production plans in the event of an emergency that results
in high absenteeism at one or more production

facilities. The purpose of the draft guidance is to provide to industry
considerations for developing such emergency plans, as well as to
discuss the Center for Drug Evaluation and Research's (CDER's) intended
approach to assist in avoiding drug product shortages that may have a
negative impact on the national public health during such emergencies.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 9, 2010. Submit written comments on the proposed collection of
information by March 9, 2010.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Thomas Christl, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., WO Bldg. 51, rm. 3359, Silver Spring, MD 20993, 301-
796-2057.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Planning for the Effects of High Absenteeism to Ensure
Availability of Medically Necessary Drug Products.'' The draft guidance
encourages manufacturers of medically necessary drug products (MNPs)
and components to develop contingency production plans in the event of
an emergency that results in high absenteeism at one or more production
facilities. In particular, the draft guidance provides recommendations
regarding considerations for the development and implementation of a
contingency production plan, including specific elements to include in
such a plan. The draft guidance is intended for manufacturers of
finished drug products as well as manufacturers of the raw materials
necessary for manufacturing an MNP.
    The purpose of this draft guidance is to provide to industry
considerations for developing emergency plans, as well as to discuss
CDER's intended approach to assist in avoiding shortages that may have
a negative impact on the national public health during such
emergencies. This draft guidance applies to manufacturers of drug and
therapeutic biologic products regulated by CDER, and any components of
those products. These considerations include, but are not limited to:
     General preparedness through employee education and
immunization,
     Prioritization of manufactured products based on medical
necessity,
     Developing training, manufacturing and laboratory
contingencies for high absenteeism, and
     How to plan for returning to normal operations.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing this
notice of the proposed collection of information set forth in this
document.
    With respect to the collection of information associated with this
draft guidance, FDA invites comments on these topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    The draft guidance recommends that manufacturers of drug and
therapeutic biological products and manufacturers of raw materials and
components used in those products develop a written Emergency Plan
(Plan) for maintaining an adequate supply of MNPs during an emergency
that results in high employee absenteeism. The draft guidance discusses
the issues that should be covered by the Plan, such as: (1) Identifying
a person or position title (as well as two designated alternates) with
the authority to activate and deactivate the Plan and make decisions
during the emergency; (2) prioritizing the manufacturer's drug products
based on medical necessity; (3) identifying actions that should be
taken prior to an anticipated period of high absenteeism; (4)
identifying criteria for activating the Plan; (5) performing quality
risk assessments to determine which manufacturing activities may be
reduced to enable the company to meet a demand for MNPs; (6) returning
to normal operations and conducting a post-execution assessment of the
execution outcomes; and (7) testing the Plan. The draft guidance
recommends developing a Plan for each individual manufacturing facility
as well as a broader Plan that addresses multiple sites within the
organization (for purposes of this analysis, we consider the Plan for
an individual manufacturing facility as well as the broader Plan to
comprise one Plan for each manufacturer). Based on CDER's

data on the number of manufacturers that would be covered by the draft
guidance, we estimate that approximately 70 manufacturers will develop
an Emergency Plan as recommended by the draft guidance (i.e., 1 Plan
per manufacturer to include all manufacturing facilities, sites, and
drug products), and that each Plan will take approximately 500 hours to
develop, maintain, and update.
    The draft guidance also encourages manufacturers to include a
procedure in their Plan for notifying CDER when the Plan is activated
and when returning to normal operations. The draft guidance recommends
that these notifications occur within 1 day of a Plan's activation and
within 1 day of a Plan's deactivation. The draft guidance specifies the
information that should be included in these notifications, such as
which drug products will be manufactured under altered procedures,
which products will have manufacturing temporarily delayed, and any
anticipated or potential drug shortages. We expect that approximately
two notifications (for purposes of this analysis, we consider an
activation and a deactivation notification to equal one notification)
will be sent to CDER by approximately two manufacturers each year, and
that each notification will take approximately 16 hours to prepare and
submit.
    This draft guidance also refers to previously approved collections
of information found in FDA regulations. Under the draft guidance, if a
manufacturer obtains information after releasing a MNP under its Plan
leading to suspicion that the product might be defective, CDER should
be contacted immediately<EMAIL_ADDRESS>in adherence to
existing recall reporting regulations (21 CFR 7.40) (OMB control number
0910-0249) or defect reporting requirements for drug application
products (21 CFR 314.81(b)(1)) and therapeutic biological products
regulated by CDER (21 CFR 600.14) (OMB control numbers 0910-0001 and
0910-0458, respectively).
    The following collections of information found in FDA current good
manufacturing practice (CGMP) regulations in part 211 (21 CFR part 211)
are approved under OMB control number 0190-0139. The draft guidance
encourages manufacturers to maintain records, in accordance with the
CGMP requirements (see, e.g., Sec.  211.180), that support decisions to
carry out changes to approved procedures for manufacturing and release
of products under the Plan. The draft guidance states: A Plan should be
developed, written, reviewed, and approved within the site's change
control quality system in accordance with the requirements in
Sec. Sec.  211.100(a) and 211.160(a); execution of the Plan should be
documented in accordance with the requirements described in Sec.
211.100(b); and standard operating procedures should be reviewed and
revised or supplementary procedures developed and approved to enable
execution of the Plan.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of       Number of Responses                         Hours per
                                                           Respondents        per Respondent      Total Responses        Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notify FDA of Plan activation and deactivation                          2                     1                  2                 16                 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

                                                       Table 2.--Estimated Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of        Number of Records
                                                          Recordkeepers      per Recordkeeping     Total Records    Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop initial Plan                                                   70                     1                 70                500             35,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                35,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: January 4, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-87 Filed 1-7-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76035-76036]
[FR Doc No: 2022-26915]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC22-74-000.
    Applicants: Wisconsin Power and Light Company, Wisconsin Public
Service Corporation, Madison Gas and Electric Company.
    Description: Wisconsin Public Service Corporation submits
Supplement to Response to September 8, 2022, Deficiency Letter.
    Filed Date: 10/11/22.
    Accession Number: 20221011-5357.
    Comment Date: 5 p.m. ET 12/8/22.

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

    Docket Numbers: ER20-2878-016.
    Applicants: Pacific Gas and Electric Company.
    Description: Compliance filing: WDT Stipulation Compliance Filing
to be effective 4/15/2021.
    Filed Date: 12/5/22.
    Accession Number: 20221205-5123.
    Comment Date: 5 p.m. ET 12/27/22.

    Docket Numbers: ER22-2933-001.
    Applicants: Nevada Power Company, Sierra Pacific Power Company.
    Description: Tariff Amendment: Nevada Power Company submits tariff
filing per 35.17(b): Response to Deficiency Letter to be effective 12/
1/2022.
    Filed Date: 12/6/22.
    Accession Number: 20221206-5078.
    Comment Date: 5 p.m. ET 12/27/22.

    Docket Numbers: ER23-52-001.
    Applicants: Westlake Chemicals & Vinyls LLC.
    Description: Tariff Amendment: Amendment to Notice of Succession in
Docket ER23-52-000 to be effective 10/12/2022.
    Filed Date: 12/6/22.
    Accession Number: 20221206-5116.
    Comment Date: 5 p.m. ET 12/27/22.

    Docket Numbers: ER23-68-002.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Revised ISA, SA No. 1949; Queue No.
NQ16 (Amend) Correction to Filing to be effective 4/17/2008.
    Filed Date: 12/6/22.
    Accession Number: 20221206-5098.
    Comment Date: 5 p.m. ET 12/27/22.

    Docket Numbers: ER23-456-001.
    Applicants: Public Service Company of Colorado.
    Description: Tariff Amendment: 2022-12-06 WAPA 359 0.2.0 Amendment
filing to be effective 12/28/2022.
    Filed Date: 12/6/22.
    Accession Number: 20221206-5046.
    Comment Date: 5 p.m. ET 12/27/22.

    Docket Numbers: ER23-563-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to OA re:
termination of Volunteer Energy Services, Inc. to be effective 2/4/
2023.
    Filed Date: 12/5/22.
    Accession Number: 20221205-5122.
    Comment Date: 5 p.m. ET 12/27/22.

    Docket Numbers: ER23-565-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Transmission Company of Illinois.
    Description: Sec.  205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per 35.13(a)(2)(iii: 2022-
12-06_SA 3936, SA 3937 & SA 3938 ATXI-Sikeston Agreements to be
effective 2/5/2023.
    Filed Date: 12/6/22.
    Accession Number: 20221206-5041.
    Comment Date: 5 p.m. ET 12/27/22.

    Docket Numbers: ER23-566-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-Coleman County EC-
Golden Spread EC 2nd A&R IA to be effective 11/17/2022.
    Filed Date: 12/6/22.
    Accession Number: 20221206-5109.
    Comment Date: 5 p.m. ET 12/27/22.

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

    Docket Numbers: ES23-2-000.
    Applicants: Lucky Corridor, LLC.
    Description: Amendment to Application Under Section 204 of the
Federal Power Act for Authorization to Issue Securities of Lucky
Corridor, LLC.
    Filed Date: 11/29/22.
    Accession Number: 20221129-5180.
    Comment Date: 5 p.m. ET 12/20/22.

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

    Dated: December 6, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-26915 Filed 12-9-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Rules and Regulations]
[Pages 67043-67049]
[FR Doc No: 2018-28077]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0393; Product Identifier 2018-NM-010-AD; Amendment
39-19536; AD 2018-26-06]
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 all The
Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER
series airplanes. This AD was prompted by reports of loose, worn, or
missing attachment bolts for the main landing gear (MLG) center door
assemblies. This AD requires repetitive detailed inspections of the
forward and aft MLG center door assembly attachments for loose,
missing, damaged, or bottomed-out attachment bolts, and any wear to the
retention clip assemblies as applicable; and applicable on-condition
actions. This AD also provides an

optional terminating action for the repetitive inspections. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective February 1, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 1,
2019.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0393.

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-2018-
0393; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is 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: Alan Pohl, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and 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 all The Boeing Company
Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes.
The NPRM published in the Federal Register on May 11, 2018 (83 FR
21948). The NPRM was prompted by reports of loose, worn, or missing
attachment bolts for the MLG center door assemblies. The NPRM proposed
to require repetitive detailed inspections of the forward and aft MLG
center door assembly attachments for loose, missing, damaged, or
bottomed-out attachment bolts, and any wear to the retention clip
assemblies as applicable; and applicable on-condition actions. The NPRM
also provided an optional terminating action for the repetitive
inspections.
    We are issuing this AD to address loose, missing, damaged, or
bottomed-out attachment bolts, and any wear to the retention clip
assemblies, which could result in departure of the center and inboard
MLG door assemblies, subsequent damage to the main flap and horizontal
stabilizer, and loss of control of the airplane.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
NPRM and the FAA's response to each comment.

Support for the NPRM

    Boeing and The Air Line Pilots Association, International, each
stated that it concurred with the intent of the NPRM.

Request for Changes to Service Information

    Alaska Airlines (Alaska) requested that changes be made to Boeing
Special Attention Service Bulletin 737-52-1170, Revision 1, dated
December 19, 2017 (``BSASB 737-52-1170, R1''). Alaska noted that
operators cannot comply with the requirements specified in paragraph
(g) of the proposed AD in cases where BSASB 737-52-1170, R1, directs
the operator to inspect a Group 3 airplane using Figure 3 or Figure 4
of BSASB 737-52-1170, R1, because those figures are not applicable to
Group 3 airplanes.
    We agree with the commenter's observations concerning Figure 3 and
Figure 4 of BSASB 737-52-1170, R1. We contacted Boeing and have
determined that the actions for Group 2 airplanes are appropriate for
all airplanes to comply with the requirements of paragraph (g) of this
AD. We have revised paragraph (h) of this AD, ``Exceptions to Service
Information Specifications,'' by adding paragraph (h)(2), which states
that ``Where BSASB 737-52-1170, R1, limits use of Figures 3 and 4 to
Group 2 airplanes, for the purposes of this AD, those figures apply to
all airplane groups.''

Request for Clarification of the Requirements of Paragraph (j) of the
Proposed AD

    Alaska requested clarification of the requirements specified in
paragraph (j) of the proposed AD and clarification of which airplane
groups would be affected by these requirements. Alaska asked if ``all
actions for Group 3'' means that this paragraph is for Group 3
airplanes only or for all airplane groups. Alaska also noted that an
inspection of the ``door assembly'' implies an inspection of the door,
but BSASB 737-52-1170, R1, describes procedures for inspection of the
``door installation.''
    We agree with the commenter's request and have revised paragraph
(j) of this AD as follows:

    As of the effective date of this AD, no person may install an
MLG assembly or MLG center door assembly on any airplane identified
in paragraphs (c)(1) through (c)(4) of this AD unless all actions
for Group 3 airplanes pertaining to that MLG center door attachment,
and identified as RC in, and in accordance with, the Accomplishment
Instructions of BSASB 737-52-1170, R1, have been accomplished on
that MLG assembly or MLG center door assembly within the compliance
times specified in Tables 4, 5, and 6, as applicable, of paragraph
1.E., ``Compliance,'' of BSASB 737-52-1170, R1. The actions for
Group 3 airplanes apply to all airplanes for the requirement of this
paragraph.

Request To Include Identification Method for Post-Modification Door

    American Airlines (American) requested that BSASB 737-52-1170, R1,
be revised to include an identifying stencil or placard that could be
placed on an affected MLG center door assembly once it has been
modified. The commenter stated that the MLG center door assembly is a
rotable part. However, neither the NPRM nor BSASB 737-52-1170, R1,
addresses the issue of a post-modification MLG center door assembly
being removed from an airplane and replaced with a pre-modification MLG
center door assembly.
    We acknowledge the commenter's concern that BSASB 737-52-1170, R1,
does not address the rotability of an MLG center door assembly. We
addressed the issue of rotability in this AD in two ways. First, the
applicability in paragraph (c) of this AD includes all Model 737-600, -
700, -700C, -800, -900, and -900ER series airplanes, not just the
airplanes specified in the effectivity of BSASB 737-52-1170, R1.
Second, we added paragraph (j) of this AD, ``Parts Installation
Limitation''.
    While marking or part marking might provide some benefit for
operator awareness and recordkeeping, the issue

of rotability is approached in different ways by different operators.
When there have been similar issues regarding rotable parts, operators
expressed a preference to not have a requirement to mark and/or part
mark, although operators may do this at their own discretion. We also
note that this AD addresses not only the MLG center door assembly but
also the attachments to the MLG strut assemblies. We have not changed
this AD in regard to this issue.

Request To Extend the Compliance Time

    Delta Air Lines (DAL) and SunExpress (SXS) requested that the
compliance time specified in paragraph (g) of the proposed AD be
extended. SXS requested that the compliance time for the initial
inspection be extended from 12,000 total flight cycles to 20,000 total
flight cycles, or from 800 flight cycles after the effective date of
the proposed AD to 1,500 flight cycles after the effective date of the
proposed AD, and that the interval for the repetitive inspection be
extended from 5,500 flight cycles to 6,600 flight cycles. SXS stated
that 41 airplanes in its fleet have exceeded 12,000 total flight
cycles, and it would have a short period of time to perform the
required inspection as described in BSASB 737-52-1170, R1, and it would
have to operate some airplanes a long time without the MLG shock strut
doors. SXS noted that performing operations without a MLG shock strut
door incurs a fuel burn penalty, which is approximately 0.77% more fuel
burned per flight.
    DAL stated that the compliance time for the initial inspection
would require them to inspect approximately 80 airplanes in a 200-day
period, requiring them to accomplish the work for most of its airplanes
in the line environment, which increases the risk for an ``airplane on
ground'' situation if there is a finding on the MLG structure. DAL
noted that BSASB 737-52-1170, R1, does not provide relief for operators
when a crack or corrosion is found in the MLG lug after removal of the
bushing. For an MLG that requires re-work, DAL typically removes the
MLG, replaces it with another MLG, and sends the discrepant MLG to a
shop for repair. We infer that DAL is requesting that the compliance
time for the initial inspection be extended.
    In addition, DAL pointed out that the procedures in BSASB 737-52-
1170, R1, would restrict an operator from dispatching an affected
airplane until corrective is taken to repair the MLG. DAL requested
that this situation be considered in the final rule by providing a
limited return to service. DAL stated that if several MLG lugs are
found with discrepancies, there is the potential of the operator
grounding airplanes outside of a heavy maintenance check to either
replace the MLG gear or go through its spare parts inventory.
    We do not agree with the commenters' requests. We appreciate the
impact that the required actions and the associated compliance times
will have on operators. However, both the FAA and Boeing have
identified this issue as an unsafe condition, and the commenters have
not provided substantiating data for their proposals. In addition, a
limited return to service would not be appropriate for dispatching
airplanes with known cracking or corrosion. As SXS has noted, airplanes
may be operated with the MLG shock strut center and inner doors removed
until repairs can be made.
    We have reviewed the related service information and note that
while repair of the MLG lug parts is required for compliance (``RC''),
certain steps are either labeled as ``RC Exempt,'' or contain technical
instructions that are prefaced by ``Refer to.'' Paragraph (l)(4) of
this AD and paragraph 3A., ``General Information,'' of BSASB 737-52-
1170, R1 specify the actions labeled as ``RC Exempt'' are not required
in order to show compliance to this AD. When the words ``refer to'' are
used within an RC step and the operator has an accepted alternative
procedure, the accepted alternative procedure can be used. When the
words ``in accordance with'' are included in an RC step, the procedure
in the Boeing document must be used. In addition, for proposals that
provide an acceptable level of safety and have substantiating data,
operators may apply for an AMOC using the procedures specified in
paragraph (l) of this AD. We have not changed this AD in regard to this
issue.

Request To Allow Installation of New, Overhauled, or Serviceable MLG

    DAL requested that operators be allowed to install a new,
overhauled, or serviceable MLG instead of repairing a damaged lug and
installing a new bushing if excessive wear, galling, or cracking is
found during a detailed inspection/measurement of the MLG shock strut
bushing. DAL stated that it would have to remove the damaged MLG and
send it to the shop for repair, and it would be easier to install a
new, overhauled, or serviceable MLG than to wait for the damaged MLG to
be repaired. DAL explained that installing a new, overhauled, or
serviceable MLG provides an equivalent level of safety because the
intent of the proposed AD is to repair and install new bushings. DAL
observed that the damaged MLG would be repaired and then be ready for
use on another airplane.
    We agree with the commenter's request for the reasons provided by
the commenter. We have revised paragraph (g) of this AD to clarify that
replacement of an entire MLG assembly within the required compliance
time satisfies the requirements of paragraph (g), provided that the
requirements of paragraph (j) of this AD, ``Parts Installation
Limitation,'' are satisfied for that MLG assembly.
    Since the unsafe condition is also affected by rotability, we have
revised paragraph (j) of this AD to clarify that an MLG assembly cannot
be installed on any airplane identified in paragraphs (c)(1) through
(c)(4) of this AD unless all actions for Group 3 airplanes have been
accomplished on the MLG assembly. Paragraph (j) of this AD states that:

    As of the effective date of this AD, no person may install an
MLG assembly or MLG center door assembly on any airplane identified
in paragraphs (c)(1) through (c)(4) of this AD unless all actions
for Group 3 airplanes pertaining to that MLG center door attachment,
and identified as RC in, and in accordance with, the Accomplishment
Instructions of BSASB 737-52-1170, R1, have been accomplished on
that MLG assembly or MLG center door assembly within the compliance
times specified in Tables 4, 5, and 6, as applicable, of paragraph
1.E., ``Compliance,'' of BSASB 737-52-1170, R1. The actions for
Group 3 airplanes apply to all airplanes for the requirement of this
paragraph.

    In the proposed AD, paragraph (j) specified only an MLG center door
assembly.

Request for Clarification of Intent of Parts Installation Paragraph (j)

    DAL stated that paragraph (j), ``Parts Installation Paragraph,'' of
the proposed AD was confusing because it stated that an operator may
not install an MLG center door assembly on an airplane unless all
actions identified as RC in BSASB 737-52-1170, R1, are accomplished
within the compliance times specified in Tables 4, 5, and 6, as
applicable, of paragraph 1.E., ``Compliance,'' of BSASB 737-52-1170,
R1. DAL observed that if an operator receives a spare door with an FAA
Form 8130, ``Authorized Release Certificate--Airworthiness Approval
Tag,'' attached, the tag might include the AD number but the number of
flight cycles at the last inspection or total flight cycles of the door
would not be provided. DAL suggested that operators ensure that the
inspection and corrective actions are accomplished before the spare
part is installed on the airplane. Therefore, if the flight cycles on
the door are unknown, the operator would still be in

compliance with the intent of the NPRM by inspecting the door before
installation, and that it would be an equivalent level of safety that
meets the intent of the NPRM.
    We appreciate the commenter's concern and the opportunity to
clarify the intent of the ``Parts Installation Limitation'' paragraph.
The compliance times specified in Tables 4, 5, and 6, as applicable, of
paragraph 1.E., ``Compliance,'' of BSASB 737-52-1170, R1, are in
airplane flight cycles. There is no requirement in this AD or any
statement in BSASB 737-52-1170, R1, that it is necessary to determine
the flight cycles accumulated on the MLG door assembly. The compliance
times in this AD are based on flight cycles of the airplane instead of
the MLG door assembly. Our strategy in addressing the unsafe condition
is to first inspect all affected airplanes, and then to address future
possible unsafe conditions with the requirements in the ``Parts
Installation Limitation'' paragraph.
    We have not made any changes to this AD in regard to this issue.

Request To Delay Issuance of Final Rule Until Service Information is
Corrected

    American, subsequent to its earlier comments, requested that the
final rule not be issued until discrepancies in BSASB 737-52-1170, R1,
are rectified and the instructions made clearer. The commenter stated
that operators cannot comply with the requirements specified in the
NPRM because of discrepancies in BSASB 737-52-1170, R1. The commenter
identified the following discrepancies.

    1. BSASB 737-52-1170, R1, has quantities listed in Figures 1 and
2 that are double what is actually on the aircraft. Although there
is a note that says ``The QTY numbers shown below are the number or
parts necessary for each airplane,'' there is a Figure 1 for the
left and a Figure 2 for the right. Each side has only one of each
bolt, not two. Note that all of the other figures list the quantity
of parts that is needed for only the left side or the right side, as
applicable. Figures 1 and 2 are different than the other figures in
this regard.
    2. In Figure 5 (and Figures 6, 7, and 8), step 6 says to remove
three laminated shims. The airplane only has two laminated shims.
    3. In Figure 13 (and Figure 14) step #4 has you install and
torque the bolt. However, the bolt in #4 has to go through the kept
bracket and if you install the bolt first, you have to take it back
out to install the bracket. Steps #4 and #5 should be reversed.
    4. In Figure 13 (and Figure 14), step #6 states to install 3
each shims, but only 2 were removed, so do we install 3 each in the
new configuration or just put 2 back?
    5. In Figure 13 (and Figure 14), once we installed the forward
bolt in step 4, with the correct washers installed, the bolt
bottomed out in the barrel nut housing, since the bolt is too long.
New bolts are slightly longer than old. The bolt needs another thick
washer to fix the issue. The kits that are being delivered do not
have an adequate amount of the necessary washers.

    Alaska also noted that Figure 13 and Figure 14 of BSASB 737-52-
1170, R1, depict view C with a pre-modification installation in lieu of
a post-modification installation.
    We acknowledge the commenters' concerns regarding the information
in the service information that requires clarification. The amount of
clarification needed would be overly complex for inclusion in this AD.
We expect to work with Boeing to issue a global AMOC addressing any
known errors as soon as possible. In addition, we have revised
paragraph (h) of this AD, ``Exceptions to Service Information
Specifications,'' by adding paragraph (h)(3) to provide operators with
information regarding how to address any other issues, if needed.
    In light of the critical nature of the identified unsafe condition,
we do not consider it warranted to delay the issuance of this final
rule. When Boeing provides a revision to BSASB 737-52-1170, R1, we will
review it in consideration of an AMOC to this AD or may consider future
rulemaking action.

Request To Revise Compliance Time Specifications

    DAL noted that paragraph (h) of the proposed AD states that ``For
purposes of determining compliance with the requirements of this AD:
Where BSASB 737-52-1170, Revision 1, uses the phrase `the original
issue date of this service bulletin', this AD requires using `the
effective date of this AD'.'' DAL pointed out that in Table 4 of BSASB
737-52-1170, R1, the compliance times for the Group 3 airplanes, states
that the actions should be completed ``Within 800 flight cycles after
the Revision 1 date of this service bulletin.'' DAL asked if the AD
effective date should also replace the Revision 1 date of the service
information. We infer that DAL is requesting a revision to paragraph
(h) of the proposed AD to clarify that for purposes of determining
compliance with the requirements of the final rule that the effective
date of the AD should be used instead of the original issue date or the
Revision 1 date of the service information.
    We agree with the commenter's request for the reasons provided by
the commenter. We have re-designated paragraph (h) of the proposed AD
as paragraph (h)(1) in this AD, and revised the text to state that for
purposes of determining compliance with the requirement of this AD,
where BSASB 737-52-1170, Revision 1, uses the phrase ``the original
issue date of this service bulletin'' or ``the Revision 1 date of this
service bulletin'' this AD requires using ``the effective date of this
AD.''

Observations Regarding Service Information

    American stated that BSASB 737-52-1170, R1, is confusing and
unnecessarily complex. American observed that BSASB 737-52-1170, R1,
provides for 14 possible conditions, multiple options for corrective
actions, 3 multi-page logic diagrams, and 10 different parts of
instructions. American stated that the complexity could be simplified
if the service information pointed the operator straight to the
modification of the MLG center door assembly retention clip assemblies
and, if needed, repair to the lugs and replacement of the bushings.
American declared that the unnecessary complexity of the service
bulletin invites non-compliance issues.
    We acknowledge the commenter's concerns regarding BSASB 737-52-
1170, R1. The reason BSASB 737-52-1170, R1, includes 14 possible
conditions, multiple options for corrective actions, 3 multi-page logic
diagrams, and 10 different parts of instructions is to provide a
comprehensive set of procedures to address the unsafe condition that
exists in the affected fleet of airplanes. We suggest that the
commenter provide its comments regarding improvements to this document
directly to Boeing. We have not changed this AD in regard to this
issue.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that accomplishing the Supplemental
Type Certificate (STC) ST00830SE does not affect the ability to
accomplish the actions specified in the NPRM.
    We concur with the commenter. We have added paragraph (c)(5) to
this AD to state that installation of STC ST00830SE does not affect the
ability to accomplish the actions required by this final rule.
Therefore, for airplanes on which STC ST00830SE is installed, a
``change in product'' alternative method of compliance (AMOC) approval
request is not necessary to comply with the requirements of 14 CFR
39.17.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule 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 for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Special Attention Service Bulletin 737-52-1170,
Revision 1, dated December 19, 2017. The service information describes
procedures for repetitive detailed inspections of the forward and aft
MLG center door assembly attachments for loose, missing, damaged, or
bottomed-out attachment bolts, and any wear to the retention clip
assemblies as applicable; and applicable on-condition actions. The
service information also describes procedures for modification of the
MLG center door assembly retention clip assemblies as an optional
terminating action for the repetitive inspections. 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.

Costs of Compliance

    We estimate that this AD affects 1,814 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
           Action                    Labor cost           Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection..................  2 work-hours x $85 per                $0  $170 per inspection  $308,380 per
                               hour = $170 per                           cycle.               inspection cycle.
                               inspection cycle.
----------------------------------------------------------------------------------------------------------------

                                 Estimated Costs for Optional Terminating Action
----------------------------------------------------------------------------------------------------------------
              Action                      Labor cost           Parts cost              Cost per product
----------------------------------------------------------------------------------------------------------------
Modification.....................  Up to 6 work-hours x $85          $2,900  Up to $3,410.
                                    per hour = $510.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.
    According to the manufacturer some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all known costs in our cost
estimate.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

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):

2018-26-06 The Boeing Company: Amendment 39-19536; Docket No. FAA-
2018-0393; Product Identifier 2018-NM-010-AD.

(a) Effective Date

    This AD is effective February 1, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 737-600, -700, -
700C, -800, -900, and -900ER series airplanes, certificated in any
category, as specified in paragraphs (c)(1) through (c)(4) of this
AD.

    (1) Airplanes in Group 1, and in Group 2, Configuration 1, as
identified in Boeing Special Attention Service Bulletin 737-52-1170,
Revision 1, dated December 19, 2017 (``BSASB 737-52-1170, R1'').
    (2) Airplanes in Group 2, Configuration 2, as identified in
BSASB 737-52-1170, R1.
    (3) Airplanes in Group 3, as identified in BSASB 737-52-1170,
R1, except where this service bulletin specifies the groups as line
numbers 4275 through 6724 inclusive, and 6736, this AD specifies
those groups as line number 4275 through any line number of an
airplane with an original Certificate of Airworthiness or an
original Export Certificate of Airworthiness dated on or before the
effective date of this AD.
    (4) All Model 737-600, -700, -700C, -800, -900, and -900ER
series airplanes with an original Certificate of Airworthiness or an
original Export Certificate of Airworthiness dated after the
effective date of this AD.
    (5) Installation of Supplemental Type Certificate (STC)
ST00830SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST00830SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Unsafe Condition

    This AD was prompted by reports of loose, worn, or missing
attachment bolts for the main landing gear (MLG) center door
assemblies. We are issuing this AD to address loose, missing,
damaged, or bottomed-out attachment bolts, and any wear to the
retention clip assemblies, which could result in departure of the
center and inboard MLG door assemblies, subsequent damage to the
main flap and horizontal stabilizer, and loss of control of the
airplane.

(f) Compliance

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

(g) Required Actions

    For airplanes identified in paragraphs (c)(1), (c)(2), or (c)(3)
of this AD: Except as required by paragraph (h) of this AD, at the
applicable time specified in Tables 1 through 6, as applicable, of
paragraph 1E., ``Compliance,'' of BSASB 737-52-1170, R1, do all
applicable actions identified as ``RC'' (required for compliance)
in, and in accordance with, the Accomplishment Instructions of BSASB
737-52-1170, R1. Replacement of an entire MLG assembly within the
required compliance time satisfies the requirements of this
paragraph, provided that the requirements of paragraph (j) of this
AD are satisfied for that MLG assembly.

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where BSASB 737-52-1170, R1, uses the phrase ``the
original issue date of this service bulletin'' or ``the Revision 1
date of this service bulletin'' this AD requires using ``the
effective date of this AD.''
    (2) Where BSASB 737-52-1170, R1, limits use of Figures 3 and 4
to Group 2 airplanes, for the purposes of this AD, those figures
apply to all airplane groups.
    (3) If any action(s) identified as RC in BSASB 737-52-1170, R1,
cannot be accomplished as specified therein, those action(s) must be
accomplished using a method approved in accordance with the
procedures specified in paragraph (l) of this AD.

(i) Optional Terminating Action for Repetitive Inspections

    Accomplishment of the modification of the MLG center door
retention clip assemblies specified in Part 5 of the Accomplishment
Instructions of BSASB 737-52-1170, R1, terminates the repetitive
inspections required by paragraph (g) of this AD for that MLG center
door retention clip only. The requirements of paragraph (j) of this
AD continue to apply.

(j) Parts Installation Limitation

    As of the effective date of this AD, no person may install an
MLG assembly or MLG center door assembly on any airplane identified
in paragraphs (c)(1) through (c)(4) of this AD unless all actions
for Group 3 airplanes pertaining to that MLG center door attachment,
and identified as RC in, and in accordance with, the Accomplishment
Instructions of BSASB 737-52-1170, R1, have been accomplished on
that MLG assembly or MLG center door assembly within the compliance
times specified in Tables 4, 5, and 6, as applicable, of paragraph
1.E., ``Compliance,'' of BSASB 737-52-1170, R1. The actions for
Group 3 airplanes apply to all airplanes for the requirement of this
paragraph.

(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 737-52-1170, dated July 29, 2014.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, 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 certification office, send it to the attention of the
person identified in paragraph (m)(1) 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, modification, or alteration 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 Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.
    (4) Except as required by paragraph (h) of this AD: For service
information that contains steps that are labeled as RC, the
provisions of paragraphs (l)(4)(i) and (l)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(m) Related Information

    (1) For more information about this AD, contact Alan Pohl,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone and 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 737-52-1170,
Revision 1, dated December 19, 2017.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (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 Des Moines, Washington, on December 18, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-28077 Filed 12-27-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Notices]
[Page 70927]
[DOCID:fr13de07-114]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) received a request for a waiver of compliance with certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

The Finger Lakes Railway Corporation (Waiver Petition Docket Number
FRA-2001-10215)

    The Finger Lakes Railway Corporation (FGLK), seeks an extension of
a waiver of compliance from certain provisions of Safety Glazing
Standards, 49 CFR Part 223 that requires certified glazing for four
passenger coaches, Car Numbers: FGLK 7201, FGLK 7202, FGLK 7601, and
FGLK7602. In addition, FGLK petitions to add two more coaches in the
waiver: FGLK 1642, and FGLK 1643.
    The FGLK petition states that the cars are still operating in the
same service environment with no changes to speed, or line segments and
are following the conditions stipulated in the existing waiver. For the
added two coaches, FGLK provided the following information in support
of its petition. The cars were built in 1916, by the Harlen and
Harrington Company for what used to be Norfolk & Western Railroad. The
cars are all of steel construction. They were refurbished in 1989-1990,
and used on the Maine Coast Railroad for excursion until 2002, when the
cars were moved to New York State for use on the Niagara and Western
New York Railroad excursion train.
    The cars have been stored on FGLK in Geneva, New York, since
October 2004. The current windows are sealed 3/8'' thick safety glass
in Adlake Company Frames. There is no damage to the windows at this
time. In all aspects, these two cars will be utilized in the same
manner and in the same locations as the four cars currently operating
under Docket Number FRA-2001-10215.
    FGLK has requested updated quotations for FRA-compliant replacement
window glass. These costs reflect the application of 49 CFR Part 223,
glass into all passenger coaches currently operating under Docket
Number FRA-2001-10215, and the two additional coaches that are being
requested in this petition. FGLK stated that glass replacement
continues to be an extremely high cost for an excursion operation and
would jeopardize any chance of profitability for such operation for
quite some time.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2001-10215) and may be submitted by any of the following methods:
    Web site: http://www.regulations.gov. Follow the online

instructions for submitting comments.
    Fax:<PHONE_NUMBER>.
    Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
    Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.

    Anyone is able to search the electronic form of any written
communications and comments received into any of our 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 DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-19478).

    Issued in Washington, DC on December 10, 2007.
Grady C. Cothen, Jr.
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E7-24189 Filed 12-12-07; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74252-74253]
[FR Doc No: 2012-30104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68384; File No. SR-ISE-2012-94]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Regarding Payment for Order Flow Fees

December 7, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 29, 2012, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission the proposed rule change, as described in Items I,
II, and III below, which items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE proposes to amend its payment for order flow fees. The text
of the proposed rule change is available on the Exchange's Web site
(http://www.ise.com), at the principal office of the Exchange, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange currently has a payment for order flow (``PFOF'')
program that helps its market makers establish PFOF arrangements with
an Electronic Access Member (``EAM'') in exchange for that EAM routing
some or all of its order flow to that market maker. This program is
funded through a fee paid by Exchange market makers for each Priority
Customer contract they execute in the symbols that are subject to the
PFOF fee.\3\ Specifically, ISE currently charges a PFOF fee of $0.65
per contract for options classes that are not in the penny pilot
program. For penny pilot classes that are not subject to the Exchange's
maker/taker fees, the Exchange currently charges a PFOF fee of $0.25
per contract.
---------------------------------------------------------------------------

    \3\ PFOF fees do not apply to market makers for each Regular
Priority Customer contract executed in Select Symbols. PFOF fees are
waived for Singly Listed Symbols, FX Options, Flash Orders and for
Complex Orders in all symbols. See Schedule of Fees, Section IV, D.
---------------------------------------------------------------------------

    The Exchange now proposes to increase the PFOF fee applicable to
classes that are not in the penny pilot program from $0.65 per contract
to $0.70 per contract. The Exchange is not proposing any change to the
PFOF fee charged to penny pilot classes that are not subject to the
Exchange's maker/taker fees. With this proposed rule change, ISE's PFOF
fee in classes that are not in the penny pilot program will be more
competitive with the PFOF fee charged by at least one other options
exchange in these options classes.\4\ This proposed rule change will
also allow ISE market makers to compete better for order flow in these
options classes.
---------------------------------------------------------------------------

    \4\ NASDAQ OMX PHLX LLC (``PHLX'') currently charges a payment
for order flow fee of $0.70 per contract for options classes that
are not in the penny pilot program. See PHLX Pricing Schedule,
Section II, Payment for Order Flow Fees.
---------------------------------------------------------------------------

    As noted above, the PFOF fee is collected by the Exchange for each
Priority Customer contract executed in the symbols where PFOF fees are
collected. For the sake of clarity, the Exchange proposes to add rule
text to its Schedule of Fees to note that the PFOF fee applies to
market makers for each Priority Customer contract executed. Aside from
adding the proposed clarifying text to its Schedule of Fees, the
Exchange is not amending its PFOF program in any other respect.
    The Exchange has designated this proposal to be operative on
December 3, 2012.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Securities Exchange Act of 1934
(``Act''),\5\ in general, and with Section 6(b)(4) of the Act,\6\ in
particular, in that it provides for the equitable allocation

of reasonable dues, fees and other charges among Exchange members and
other persons using its facilities. The proposed rule change will allow
the Exchange and its market makers to better compete for order flow
since the Exchange will now collect the same amount of fee as PHLX in
options classes that are subject to the PFOF fee. The Exchange believes
that with this proposed rule change, market makers will have greater
incentive to trade on ISE in the symbols that are subject to the PFOF
fee and thus enhance competition.
---------------------------------------------------------------------------

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

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \7\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\8\ because it establishes a due, fee, or other charge
imposed by ISE.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-ISE-2012-94 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2012-94. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commissions Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room. Copies of such filing also will
be available for inspection and copying at the principal office of the
ISE. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-ISE-
2012-94 and should be submitted by January 3, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-30104 Filed 12-12-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30730-30732]
[FR Doc No: 2019-13702]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1828]

E19 Optimisation of Safety Data Collection; International Council
for Harmonisation; Draft Guidance for Industry; 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 draft guidance for industry entitled ``E19
Optimisation of Safety Data Collection.'' The draft guidance was
prepared under the auspices of the International Council for
Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance provides recommendations regarding
appropriate use of a selective approach to safety data collection in
some late-stage pre- or postmarketing studies of drugs where the safety
profile, with respect to commonly occurring adverse events, is well
understood and documented. The draft guidance is intended to advance
important clinical research questions through the conduct of clinical
investigations that collect relevant patient data, which will enable an
adequate benefit-risk assessment of the drug for its intended use,
while reducing the burden to patients from unnecessary tests that may
yield limited additional information.

DATES: Submit either electronic or written comments on the draft
guidance by September 25, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-1828 for ``E19 Optimisation of Safety Data Collection.''
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)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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 requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Ellis Unger, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 4200, 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 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization, and FDA is committed to seeking scientifically
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
agencies.
    ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; FDA; the Japanese Ministry
of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
The Assembly is responsible for endorsing draft guidelines and adopting
final guidelines. FDA publishes ICH guidelines as FDA guidance.
    In November 2018, the ICH Assembly endorsed the draft guidance
entitled ``E19 Optimisation of Safety Data Collection'' and agreed that
the guidance should be made available for public comment. The draft
guidance is the product of the E19 Expert Working Group of the ICH.
Comments about this draft guidance will be considered by FDA and the
E19 Expert Working Group.
    The draft guidance provides recommendations regarding appropriate
use of a selective approach to safety data collection in some late-
stage pre- or postmarketing studies of drugs where the safety profile,
with respect to commonly occurring adverse events, is well understood
and documented. Recognizing that protection of patient welfare during
drug development is critically important, unnecessary data collection
may be burdensome to patients and serve as a disincentive to
participation in clinical research. By tailoring safety data collection
in some circumstances, the burden to patients would be reduced, a
larger number of informative clinical studies could be carried out with
greater efficiency, studies could be conducted with greater global
participation, and the public health would be better served. The
proposed guidance would be consistent with risk-based approaches and
quality-by-design principles.
    The draft guidance discusses when selective safety data collection
might be considered, what types of data could have limited or no
collection under this approach, and how selective data collection might
be implemented without compromising patient well-being or safety. The
draft guidance is not intended to affect the reporting of postmarketing
adverse events relevant to an approved drug or affect reporting of
requirements under an investigational new drug application. The draft
guidance is intended to advance important clinical research questions
through the conduct of clinical investigations that collect relevant
patient data, which will enable an adequate benefit-risk assessment of
the drug for its intended use, while reducing the burden to patients
from unnecessary tests that may yield limited additional information.
    This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance

practices regulation (21 CFR 10.115) and style before publication. The
draft guidance, when finalized, will represent FDA's current thinking
on ``E19 Optimisation of Safety Data Collection.'' 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.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.regulations.gov, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatory
Information/Guidances/default.htm.

    Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13702 Filed 6-26-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Page 78316]
[FR Doc No: 2020-26712]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2530-057]

Brookfield White Pine Hydro LLC; Notice of Application Tendered
for Filing With the Commission and Establishing Procedural Schedule for
Licensing and Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2530-057.
    c. Date Filed: November 20, 2020.
    d. Applicant: Brookfield White Pine Hydro LLC (White Pine Hydro).
    e. Name of Project: Hiram Hydroelectric Project.
    f. Location: The existing project is located on the Saco River in
the towns of Hiram, Baldwin, Brownfield, and Denmark within Oxford and
Cumberland Counties, Maine. The project does not affect federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Luke Anderson, Licensing Manager, Brookfield
White Pine Hydro LLC, 150 Main Street, Lewiston, ME 04240; Telephone
(207) 755-5600.
    i. FERC Contact: Dianne Rodman,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. Project Description: The existing Hiram Project consists of a
255-acre, 7.5-mile-long impoundment at normal full pond elevation 349.0
feet; a 448-foot-long dam located at the top of Great Falls fitted with
an inflatable dam across the spillway crest; an intake that is integral
to the dam; a 320-foot-long, 15.5-foot-diameter penstock that
bifurcates to one 170-foot-long by 10-foot-wide penstock (to Unit 1),
and one 80-foot-long by 15.5-foot-diameter penstock (to Unit 2); a
powerhouse containing two turbine-generator units, Unit 1 rated at 2.4
megawatts (MW) and Unit 2 at 8.1 MW, for a total installed capacity of
10.5 MW; and appurtenant facilities. The project's transmission
facilities include: (1) Generator leads; (2) a substation located
adjacent to, and north of, the powerhouse; and (3) a transmission
circuit connecting the substation to a non-project switching station.
The project generates an annual average of 45,142 megawatt-hours.
    White Pine Hydro proposes to continue to: operate the project in a
run-of-river mode from October 1 through November 15, with head pond
drawdowns limited to 1 foot or less from the full pond elevation, or
from the spillway crest when the inflatable dam is down. From November
16 through September 30, White Pine Hydro proposes to continue to cycle
daily operations whereby it would turn on and off its generating units
when inflow is sufficient to meet load demands, resulting in drawdown
of the head pond by up to 2 feet from the full pond elevation during
normal project operation, or from the spillway crest when the
inflatable dam is down. During this period, White Pine Hydro would
continue to provide a minimum flow of 300 cubic feet per second (cfs),
of inflow, whichever is less below the powerhouse.
    White Pine Hydro proposes to remove from the current project
boundary 152 acres of land and 25 acres of water.
    l. In addition to publishing the full text of this notice in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this notice, as well
as other documents in the proceeding (e.g., license application) via
the internet through the Commission's Home Page (http://www.ferc.gov)
using the eLibrary link. Enter the docket number excluding the last
three digits in the docket number field to access the document (P-
2530). At this time, the Commission has suspended access to the
Commission's Public Reference Room due to the proclamation declaring a
National Emergency concerning the Novel Coronavirus Disease (COVID-19)
issued by the President on March 13, 2020. For assistance, contact FERC
at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
(202) 502-8659 (TTY).
    m. You may also register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Procedural Schedule:
    The application will be processed according to the following
preliminary Hydro Licensing Schedule. Revisions to the schedule may be
made as appropriate.

------------------------------------------------------------------------
              Milestone                           Target Date
------------------------------------------------------------------------
Notice of Acceptance/Notice of Ready   January 2021.
 for Environmental Analysis.
Filing of recommendations,             March 2021.
 preliminary terms and conditions,
 and fishway prescriptions.
Reply Comments due...................  May 2021.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: November 30, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-26712 Filed 12-3-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Page 78730]
[FR Doc No: 2015-31758]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0021; FRL-9939-25]

Pesticide Product Registration; Receipt of Application for a New
Active Ingredient

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received an application to register a pesticide
product containing an active ingredient not included in any currently
registered pesticide products. Pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice
of receipt and opportunity to comment on this application.

DATES: Comments must be received on or before January 19, 2016.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number and the File Symbol of interest as shown in
the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Registration Application

    EPA has received an application to register a pesticide product
containing an active ingredient not included in any currently
registered pesticide products. Pursuant to the provisions of FIFRA
section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice
of receipt and opportunity to comment on this application. Notice of
receipt of this application does not imply a decision by the Agency on
this application.
    File Symbol: 70051-REN. Docket ID number: EPA-HQ-OPP-2015-0748.
Applicant: Certis USA, LLC, 9145 Guilford Rd., Suite 175, Columbia, MD
21046. Product name: Trident Biological Insecticide. Active ingredient:
Insecticide--Bacillus thuringiensis variety tenebrionis strain SA-10 at
14.32%. Proposed uses: Agricultural and residential. Contact: BPPD.

    Authority: 7 U.S.C. 136 et seq.

    Dated: December 7, 2015.
R. McNally,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 2015-31758 Filed 12-16-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 26, 2007 (Volume 72, Number 17)]
[Notices]
[Page 3818-3819]
[DOCID:fr26ja07-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-134-000]

Maritimes & Northeast Pipeline, L.L.C.; Notice of Proprosed
Changes in FERC Gas Tariff

January 17, 2007.
    Take notice that on January 12, 2007, Maritimes & Northeast
Pipeline, L.L.C. (Maritimes) tendered for filing as a part of its FERC
Gas Tariff, First Revised Volume No. 1, Sixth Revised Sheet No. 210A
and Third Revised Sheet No. 214 to reflect a corporate identity change
effective January 1, 2007. This effective date coincides with the date
Spectra Energy Corp was divested from Duke Energy Corporation.
    Maritimes states that the tariff changes are only of a non-
substantive nature as a result of the divestiture and are related to
the designation of the LINK System[supreg] Web site.
    Maritimes states that copies of its filing have been served upon
all affected customers of Maritimes and interested State commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance

with the provisions of Section 154.210 of the Commission's regulations
(18 CFR 154.210). Anyone filing an intervention or protest must serve a
copy of that document on the Applicant. Anyone filing an intervention
or protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E7-1150 Filed 1-25-07; 8:45 am]

BILLING CODE 6717-01-P