[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41497-41498]
[FR Doc No: 2015-17316]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2011-0891; FRL-9930-58-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Recordkeeping and Periodic Reporting of the
Production, Import, Recycling, Destruction, Transhipment, and Feedstock
Use of Ozone-Depleting Substances (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Recordkeeping and Periodic
Reporting of the Production, Import, Recycling, Destruction,
Transhipment, and Feedstock Use of Ozone-Depleting Substances
(Renewal)'' (EPA ICR No. 1432.31, OMB Control No. 2060-0170) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Public comments were previously requested via the Federal Register (80
FR 24917) on May 1, 2015 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An Agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before August 14,
2015.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2011-0891, to (1) EPA online using www.regulations.gov (our
preferred method) or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Robert Burchard, Stratospheric
Protection Division, Office of Atmospheric Programs (6205J),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The Montreal Protocol on Substances that Deplete the
Ozone Layer (Protocol) and Title VI of the Clean Air Act Amendments of
1990 (CAA) established limits on total U.S. production, import, and
export of Class I and Class II controlled ozone depleting substances
(ODSs). Under its Protocol commitments, the United States has been
obligated to cease production and import of Class I controlled
substances with exemptions for essential uses, critical uses,
previously used material, and material that will be transformed,
destroyed, or exported to developing countries. The Protocol also
establishes limits and reduction schedules leading

to the eventual phaseout of Class II controlled substances with similar
exemptions beyond the phaseout. Additionally, the CAA has its own
limits on production and consumption of controlled substances that EPA
must adhere to and enforce.
    To ensure the United States' compliance with the limits and
restrictions established by the Protocol and the CAA, the ODS phaseout
regulations establish control measures for individual companies. EPA
monitors compliance with the limits and restrictions for individual
United States companies through the recordkeeping and reporting
requirements established in the regulations at 40 CFR part 82, subpart
A. To submit required information, regulated entities can download
reporting forms, complete them, and then send them to EPA via mail,
fax, or electronically. Upon receipt of the reports, EPA enters and
stores the data in the ODS Tracking System. The Tracking System is a
secure database that maintains all of the data that is submitted to EPA
and allows the Agency to: (1) Track over total production and
consumption of controlled substances to satisfy conditions of the CAA
and fulfill the United States obligations under the Protocol; (2)
monitor compliance with limits and restrictions on production, imports,
exports, and specific exemptions to the phaseout for individual U.S.
companies; and (3) enforce against illegal imports and violations
related to the control of Class I and Class II substances.
Additionally, reporting on the exemptions allows an entity to retain
the benefit of being able to produce or import a controlled Class I ODS
beyond the date of complete phaseout.
    Pursuant to regulations 40 CFR part 2, subpart B, reporting
businesses are entitled to assert a business confidentiality claim
covering any part of the submitted business information as defined in
40 CFR part 2, subpart B.
    Respondents/affected entities: Chemical Producers, Importers, and
Exporters (CFCs); Research and Development (Laboratories); and MeBr
Producers, Importers, Exporters, Distributors, and Applicators.
    Estimated number of respondents: 1845 (total).
    Frequency of response: quarterly, annually, occasionally.
    Total estimated burden: 2583 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $280,055 (per year), includes $5,535
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in the total estimated
respondent burden compared with the ICR currently approved by OMB.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-17316 Filed 7-14-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Proposed Rules]
[Pages 38941-38943]
[FR Doc No: 2021-15518]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0577; Project Identifier AD-2021-00470-E]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Division Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2021-05-16, which applies to certain Pratt & Whitney Division (PW)
PW4164, PW4164-1D, PW4168, PW4168-1D, PW4168A, PW4168A-1D, and PW4170
model turbofan engines. AD 2021-05-16 requires initial and repetitive
replacements of the low-pressure turbine (LPT) 4th-stage air sealing
ring segment assemblies with parts eligible for installation. AD 2021-
05-16 also requires initial and repetitive dimensional inspections of
the LPT case for bulging and, depending on the results of the
dimensional inspections, repair or replacement of the LPT case. Since
the FAA issued AD 2021-05-16, the FAA was notified of an inadvertent
omission in the LPT 4th-stage air sealing ring segment assembly part
numbers. This proposed AD would correct this omission. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by September
7, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Pratt &
Whitney, 400 Main Street, East Hartford, CT 06118; phone: (800) 565-
0140; email<EMAIL_ADDRESS>website: https://prattwhitney.com. You may view this service information at the
Airworthiness Products Section, Operational Safety Branch, FAA, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0577; 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 NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Carol Nguyen, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0577; Project Identifier
AD-2021-00470-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact the FAA receives about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Carol
Nguyen, Aviation Safety Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803. Any commentary that the FAA receives
which is not specifically designated as CBI will be placed in the
public docket for this rulemaking.

Background

    The FAA issued AD 2021-05-16, Amendment 39-21459 (86 FR 17287,
April 2, 2021), (AD 2021-05-16), for certain PW PW4164, PW4164-1D,
PW4168, PW4168-1D, PW4168A, PW4168A-1D, and PW4170 model turbofan
engines with LPT 4th-stage air sealing ring segment assemblies, part
number (P/N) 50N463-01 or P/N 50N526-01, installed. AD 2021-05-16 was
prompted by six reports from the manufacturer concerning LPT 4th-stage
vane cluster assemblies leaning back and notching into rotating LPT
4th-stage blades, causing some blades to fracture and release. These
incidents resulted in an aborted takeoff, air turnbacks, engine surges,
high vibrations, and unplanned engine removals. The incidents were
attributed to the LPT 4th-stage air sealing ring segment assemblies
moving into the LPT 4th-stage blades knife edge seals, resulting in
damage to the ring

segment assemblies. AD 2021-05-16 requires initial and repetitive
replacements of the LPT 4th-stage air sealing ring segment assemblies
with parts eligible for installation. AD 2021-05-16 also requires
initial and repetitive dimensional inspections of the LPT case for
bulging and, depending on the results of the dimensional inspections,
repair or replacement of the LPT case. The agency issued AD 2021-05-16
to prevent damage to the LPT 4th-stage air sealing ring segment
assemblies, the LPT case, and the LPT 4th-stage blades. The unsafe
condition, if not addressed, could result in uncontained release of the
LPT 4th-stage blades, damage to the engine, and damage to the airplane.

Actions Since AD 2021-05-16 Was Issued

    Since the FAA issued AD 2021-05-16, the FAA was notified by a
manufacturer of parts manufacturer approval (PMA) parts and that
paragraphs (c), (g), and (h) of the AD should include affected PMA part
numbers because the unsafe condition also applies to those parts. The
FAA added FAA-approved equivalent part numbers to paragraphs (c), (g),
and (h) of this AD to include PMA part numbers.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Pratt & Whitney Alert Service Bulletin No. PW4G-
100-A72-262, Revision No. 1, dated September 3, 2020 (the ASB). The ASB
specifies procedures for replacing the LPT 4th-stage air sealing ring
segment assemblies and inspecting the LPT case for bulging. The
Director of the Federal Register approved the ASB for incorporation by
reference as of May 7, 2021 (86 FR 17287, April 2, 2021). 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 ADDRESSES.

Proposed AD Requirements in This NPRM

    This proposed AD would retain all the requirements of AD 2021-05-
16. This proposed AD would add ``or FAA-approved equivalent part
numbers'' to paragraph (c), Applicability; paragraph (g), Required
Actions; and paragraph (h), Definitions, of this AD. This proposed AD
would also add paragraph (i), Credit for Previous Actions, allowing
operators to take credit for the required actions in paragraph (g)(4)
of this AD if, prior to the effective date of this AD, operators
performed dimensional inspections of the LPT case for bulging using
Pratt & Whitney ASB No. PW4G-100-A72-262, Original Issue, dated October
22, 2019.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 99 engines installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspect the LPT case for bulging......  2 work-hours x $85 per                $0            $170         $16,830
                                         hour = $170.
Replace the LPT 4th-stage air sealing   50 work-hours x $85 per           64,592          68,842       6,815,358
 ring segment assemblies.                hour = $4,250.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary repair or
replacement that would be required based on the results of the proposed
inspection. The agency has no way of determining the number of aircraft
that might need these repairs or replacements.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Repair LPT case to restore dimensions.........  250 work-hours x $85 per hour =               $0         $21,250
                                                 $21,250.
Replace the LPT case..........................  0 work-hours x $85 per hour = $0       1,300,000       1,300,000
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:
0
a. Removing Airworthiness Directive AD 2021-05-16, Amendment 39-21459
(86 FR 17287, April 2, 2021); and
0
b. Adding the following new airworthiness directive:

Pratt & Whitney Division: Docket No. FAA-2021-0577; Project
Identifier AD-2021-00470-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) action by September 7, 2021.

(b) Affected ADs

    This AD replaces AD 2021-05-16, Amendment 39-21459 (86 FR 17287,
April 2, 2021).

(c) Applicability

    This AD applies to Pratt & Whitney Division (PW) PW4164, PW4164-
1D, PW4168, PW4168-1D, PW4168A, PW4168A-1D, and PW4170 model
turbofan engines with low-pressure turbine (LPT) 4th-stage air
sealing ring segment assemblies, part number (P/N) 50N463-01, P/N
50N526-01, or FAA-approved equivalent part numbers, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by several reports from the manufacturer
concerning LPT 4th-stage vane cluster assemblies leaning back and
notching into the rotating LPT 4th-stage blades, causing some blades
to fracture and release. A manufacturer investigation into those
reports determined that the leaning back of the LPT 4th-stage vane
cluster assemblies was caused by damage to the LPT 4th-stage air
sealing ring segment assemblies. The FAA is issuing this AD to
prevent damage to the LPT 4th-stage air sealing ring segment
assemblies, the LPT case, and the LPT 4th-stage blades. The unsafe
condition, if not addressed, could result in uncontained release of
the LPT 4th-stage blades, damage to the engine, and damage to the
airplane.

(f) Compliance

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

(g) Required Actions

    (1) For affected engines that have either the Talon IIA outer
combustion chamber assembly, P/N 51J100 or P/N 51J382, or the Talon
IIB outer combustion chamber assembly, P/N 51J381 or P/N 51J500,
installed, at the next engine shop visit after the effective date of
this AD, remove from service the LPT 4th-stage air sealing ring
segment assemblies, P/N 50N463-01, P/N 50N526-01, or FAA-approved
equivalent part numbers, and replace with parts eligible for
installation.
    (2) For affected engines not referenced in paragraph (g)(1) of
this AD, at the next LPT overhaul after the effective date of this
AD, remove from service the LPT 4th-stage air sealing ring segment
assemblies, P/N 50N463-01, P/N 50N526-01, or FAA-approved equivalent
part numbers, and replace with parts eligible for installation.
    (3) For all affected engines, at each LPT overhaul after
compliance with the required actions in paragraphs (g)(1) or (2) of
this AD, remove from service the LPT 4th-stage air sealing ring
segment assemblies, P/N 50N526-01 or FAA-approved equivalent part
numbers, and replace with parts eligible for installation.
    (4) During each replacement of the LPT 4th-stage air sealing
ring segment assemblies required by paragraphs (g)(1) through (3) of
this AD, perform a dimensional inspection of the LPT case for
bulging in accordance with the Accomplishment Instructions,
paragraph 2, of PW Alert Service Bulletin No. PW4G-100-A72-262
Revision No. 1, dated September 3, 2020 (the ASB).
    (5) If, during the dimensional inspection of the LPT case
required by paragraph (g)(4) of this AD, any LPT case found to be
outside the serviceable limits specified in Table 1: Serviceable
Limits and Repairs of the ASB, repair or replace the LPT case before
further flight.

(h) Definitions

    For the purpose of this AD:
    (1) An ``engine shop visit'' is the induction of an engine into
the shop for maintenance involving the separation of pairs of major
mating engine flanges H through P. The separation of engine flanges
solely for the purpose of transportation without subsequent engine
maintenance does not constitute an engine shop visit.
    (2) An ``LPT overhaul'' is when the LPT rotor is removed from
the engine, all four disks are removed from the LPT rotor, and all
blades are removed from the disks.
    (3) ``Parts eligible for installation'' are LPT 4th-stage air
sealing ring segment assemblies, P/N 50N526-01, or FAA-approved
equivalent part numbers, with zero flight cycles since new or with a
P/N not mentioned in this AD.

(i) Credit for Previous Actions

    You may take credit for the dimensional inspection of the LPT
case for bulging required by paragraph (g)(4) of this AD if the
inspection was performed before the effective date of this AD using
PW ASB No. PW4G-100-A72-262 Original Issue, dated October 22, 2019.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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 Related Information. 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.

(k) Related Information

    (1) For more information about this AD, contact Carol Nguyen,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact Pratt
& Whitney, 400 Main Street, East Hartford, CT 06118; phone: (800)
565-0140; email<EMAIL_ADDRESS>website: https://prattwhitney.com. You may view this referenced service information
at the FAA, Airworthiness Products Section, Operational Safety
Branch, 1200 District Avenue, Burlington, MA 01803. For information
on the availability of this material at the FAA, call (781) 238-
7759.

    Issued on July 16, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-15518 Filed 7-22-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 17, 2005 (Volume 70, Number 199)]
[Notices]
[Page 60320-60321]
[DOCID:fr17oc05-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-704-000]

SCG Pipeline, Inc.; Notice of Tariff Filing

October 6, 2005.
    Take notice that on September 30, 2005, SCG Pipeline, Inc. (SCG)
tendered for filing as part of its FERC Gas Tariff, Original Volume No.
1, Third Revised Sheet No. 8 to be effective November 1, 2005.
    SCG states that a copy of this filing has been served upon all of
its customers and affected 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. E5-5675 Filed 10-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Page 56682]
[FR Doc No: 2016-19534]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0018]

FEMA Directive 108-1 and FEMA Instruction 108-1-1

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of availability.

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SUMMARY: This document provides notice of availability of final FEMA
Directive 108-1 and FEMA Instruction 108-1-1 (referred to as Directive
and Instruction). Together, this Directive and Instruction serve as
FEMA's supplemental instructions for Environmental Planning and
Historic Preservation (EHP), in accordance with the Department of
Homeland Security's (DHS) Directive 023-01, Rev. 01 and Instruction
Manual 023-01-001-01, Rev. 01, Implementation of the National
Environmental Policy Act (NEPA).

DATES: This final Directive and Instruction are effective August 22,
2016.

ADDRESSES: The final Directive and Instruction are available online at
http://www.regulations.gov (docket ID FEMA-2016-0018) and on FEMA's Web
site at https://www.fema.gov/media-library/assets/documents/118323. You
may also view a hard copy of the final Directive and Instruction at the
Office of Chief Counsel, Federal Emergency Management Agency, Room 835,
500 C Street SW., Washington, DC 20472.

FOR FURTHER INFORMATION CONTACT: Katherine Zeringue, Environmental
Officer, Federal Emergency Management Agency, 400 C Street SW., Suite
313, Washington, DC 20472-3020;<PHONE_NUMBER>, or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 26, 2014, DHS issued revised
NEPA implementing procedures, applicable to all DHS components, via
Directive 023-01 and Instruction 023-01-001-01, which went into effect
on March 26, 2015 (79 FR 70538). The EHP Directive and Instruction
operate jointly to constitute FEMA's supplemental EHP procedures in
accordance with the DHS Directive and Instruction. The Directive
establishes FEMA's policies, roles, responsibilities, and procedures
for delegations of authority concerning EHP. The Instruction provides
guidance and policy direction for implementation of NEPA and other EHP
requirements across FEMA.
    The EHP Directive and Instruction replace 44 CFR part 10:
Environmental Considerations. The EHP Instruction also replaces the
following policy memoranda:
    A. Environmental Policy Memo 108.024.2: Other Federal Agency
Clearance for Environmental Assessments (December 18, 2013).
    B. Environmental Policy Memo 108.024.4: Projects Initiated Without
Environmental Review Required by the National Environmental Policy Act
(December 18, 2013).

    Authority: The Directive and Instruction are consistent with the
DHS Directive 023-01 and Instruction 023-01-001-01 for
implementation of the National Environmental Policy Act of 1969
(NEPA) (42 U.S.C. 4321 et seq.), as amended, and the Council on
Environmental Quality (CEQ) regulations for implementing the
procedural provisions of NEPA (40 CFR parts 1500-1508).

    Dated: August 2, 2016.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-19534 Filed 8-19-16; 8:45 am]
 BILLING CODE 9110-A6-P


[Federal Register: June 12, 2008 (Volume 73, Number 114)]
[Notices]
[Page 33436-33438]
[DOCID:fr12jn08-80]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0067] (formerly Docket No. 2001D-0185)

Draft Guidance for Industry on Providing Regulatory Submissions
in Electronic Format--Postmarketing Individual Case Safety Reports;
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 ``Providing
Regulatory Submissions in Electronic Format--Postmarketing Individual
Case Safety Reports.'' This draft guidance consolidates and revises
information in two existing draft guidances pertaining to electronic
submission of postmarketing individual case safety reports (ICSRs) and
attachments to ICSRs (ICSR attachments). The submission of ICSRs and
ICSR attachments in an electronic format significantly improves the
agency's efficiency in processing, archiving, and reviewing the
reports.

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 comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance,
including comments regarding proposed collection of information, by
August 11, 2008.

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, or to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448. Send one self-addressed adhesive label to assist that
office in processing your

requests. The guidance may also be obtained by calling CBER at 1-800-
835-4709 or<PHONE_NUMBER>. 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:
    Roger Goetsch, Center for Drug Evaluation and Research (HFD-410),
Food and Drug Administration, 12300 Twinbrook Pkwy., suite 240,
Rockville, MD 20851,<PHONE_NUMBER>; or
    Steven Ripley, Center for Biologics Evaluation and Research (HFM-
17),Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852,301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Postmarketing Individual Case Safety Reports'' (the electronic ICSR
draft guidance). The electronic ICSR draft guidance will apply to drug
products marketed for human use with approved new drug applications
(NDAs) and abbreviated new drug applications (ANDAs); prescription drug
products marketed for human use without an approved NDA or ANDA;
nonprescription drug products marketed without an approved application;
biological products, including therapeutic vaccines, marketed for human
use with approved biologic license applications (BLAs) and submission
tracking numbers (STNs); and human cells, tissues, and cellular and
tissue-based products (HCT/Ps) regulated under section 361 of the
Public Health Service Act (the PHS Act) (42 U.S.C. 264). The electronic
ICSR draft guidance will not apply to prophylactic vaccines, whole
blood, or components of whole blood.

A. Consolidation of Earlier Guidance

    This electronic ICSR draft guidance consolidates and revises
information pertaining to electronic submission of postmarketing ICSRs
and ICSR attachments in the following guidances:
     Draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Postmarketing Expedited
Safety Reports'' issued in May 2001 (Expedited Reports draft guidance)
(66 FR 22585, May 4, 2001), and
     Draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Postmarketing Periodic
Adverse Drug Experience Reports'' issued in June 2003 (Periodic Reports
draft guidance) (68 FR 37504, June 24, 2003).
    The electronic ICSR draft guidance replaces the Expedited Reports
draft guidance in its entirety, and we have removed the Expedited
Reports draft guidance from the Center for Drug Evaluation and Research
(CDER) and CBER's guidance pages. The electronic ICSR draft guidance
also replaces the ICSR and ICSR attachment portion of the Periodic
Reports draft guidance, but does not address the descriptive
information portion. We have removed the Periodic Reports draft
guidance from CDER and CBER's guidance pages. For information on
electronic submission of the descriptive information portion of
periodic adverse drug experience reports, see the section on periodic
safety update reports in the guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Human Pharmaceutical
Product Applications and Related Submissions Using the eCTD
Specifications'' (see Revision 2, June 2008).

B. International Standards for Electronic Transmission

    FDA has cooperated with industry associations, standards
development organizations, and the regulatory authorities of certain
other nations to promote international harmonization of regulatory
requirements. Much of this effort has been coordinated through the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH). Under the auspices
of the ICH, standards for electronic submission of safety information
for human drug and biological products have been developed. This draft
guidance is intended to provide guidance to industry regarding
submission of postmarketing ICSRs and ICSR attachments to FDA in
electronic form using the standards established by the ICH.

C. Updated Recommendations

    As a result of comments received on the Expedited Reports and
Periodic Reports draft guidances, as well as evolving technology, a
number of substantive changes have been made to the agency's
recommendations for the electronic transmission of ICSRs and ICSR
attachments. In addition to consolidating all the information
pertaining to electronic submission of ICSRs and ICSR attachments into
a single guidance, the electronic ICSR draft guidance also provides
references to technical specifications for these submissions.
    Since the Expedited Reports and Periodic Reports draft guidances
were issued, the agency has received ICSRs for HCT/Ps regulated under
section 361 of the PHS Act. On December 22, 2006, the President signed
the Dietary Supplement and Nonprescription Drug Consumer Protection Act
(Public Law 109-462), which amended the Federal Food, Drug, and
Cosmetic Act to add safety reporting requirements for nonprescription
drug products marketed without an approved application (21 U.S.C.
379aa). The recommendations in this electronic ICSR draft guidance will
apply to these products as well as to products with approved NDAs,
ANDAs, BLAs and STNs, and prescription drug products marketed without
an approved NDA or ANDA.
    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 providing
postmarketing ICSRs and ICSR attachments in electronic format. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations/gov.

III. Paperwork Reduction Act of 1995

    This electronic ICSR draft guidance refers to proposed collections
of information required by Public Law 109-462 and subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As required by the PRA,
FDA is now requesting public comment (see DATES) on these proposed
collections of information. The agency's analysis and estimates of the
proposed collections of information in the electronic ICSR draft
guidance that are required by Public Law 109-462 have been described
previously in FDA's notice of availability for a draft guidance
entitled ``Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application'' (72 FR
58316, October 15, 2007) (the October 2007 PRA analysis). For burden
estimates for the proposed collections of information in the electronic
ICSR draft guidance, see the October 2007 PRA analysis.
    This electronic ICSR draft guidance also refers to previously
approved collections of information found in FDA regulations. The
collections of information in 21 CFR 310.305, 314.80, 600.80, and
1271.350 have been approved under OMB control numbers 0910-0291, 0910-
0230, 0910-0308, and 0910-0543 respectively.

IV. Electronic Access

    Persons with access to the Internet may obtain the document
athttp://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/
guidelines.htm, or http://www.regulations.gov.

    Dated: June 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13269 Filed 6-11-08; 8:45 am]

BILLING CODE 4160-01-S