[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Proposed Rules]
[Pages 14703-14706]
[FR Doc No: 2012-5493]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0097]
RIN 1625-AA00

Safety Zone, Temporary Change for Recurring Fireworks Display
Within the Fifth Coast Guard District, Pamlico River and Tar River;
Washington, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing a temporary change to the
enforcement period and location of safety zone regulations for a
recurring fireworks display within the Fifth Coast Guard District. This
regulation applies to two recurring fireworks display events that take
place at Washington, NC. Safety zone regulations are necessary to
provide for the safety of life on navigable waters during the event.
This action is intended to restrict vessel traffic in a portion of the
Pamlico River and Tar River near Washington, NC, during the event.

DATES: Comments and related material must be received by the Coast
Guard on or before April 12, 2012.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0097 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except

Federal holidays. The telephone number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Chief Warrant Officer Joseph Edge, Prevention
Department, Coast Guard Sector North Carolina, Atlantic Beach, NC;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Coast Guard anticipates that this
proposed rule, when final, will be effective from June 7, 2012, until
July 8, 2012, and enforced on the specific dates provided in the
amendatory instructions in this document.

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2012-0097), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via www.regulations.gov, it will be considered received
by the Coast Guard when you successfully transmit the comment. If you
fax, hand deliver, or mail your comment, it will be considered as
having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2012-0097'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2012-0097'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before March 21, 2012, using one of the four
methods specified under ADDRESSES. Please explain why you believe a
public meeting would be beneficial. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register.

Background and Purpose

    Fireworks display events are frequently held on or adjacent to
navigable waters within the boundary of the Fifth Coast Guard District.
For a description of the geographical area of each Coast Guard Sector--
Captain of the Port Zone, please see 33 CFR 3.25.
    This regulation temporarily changes the enforcement period and
geographic location for a safety zone for two annually recurring
fireworks events, described at (d)(7) of the Table to 33 CFR 165.506,
that are normally scheduled to occur each year on the second Saturday
in June and on the first Saturday after July 4th.
    On June 8, 2012 and July 4, 2012, the Town of Washington, NC will
sponsor their annual fireworks events. These events will take place in
Washington, NC on the waters of the Pamlico River. The regulation at 33
CFR 165.506 is enforced annually for this event. Also, a fleet of
spectator vessels is expected to gather near the event site to view the
fireworks. To provide for the safety of participants, spectators, and
transiting vessels, the Coast Guard will temporarily restrict vessel
traffic in the event area from 7:30 p.m. to 10 p.m. on June 8, 2012 and
July 4, 2012. The regulation at 33 CFR 165.506 will be enforced for the
duration of the event. Vessels may not enter the regulated area unless
they receive permission from the Coast Guard Patrol Commander.

Discussion of Proposed Rule

    The Coast Guard is temporarily changing the enforcement period and
geographic location of the safety zone for these recurring events
within the Fifth Coast Guard District. This regulation applies to only
the fireworks events listed at (d)7 in the Table to Sec.  165.506.
    The Table to Sec.  165.506, event (d)7, establishes the enforcement
date and geographic location for the fireworks events held in
Washington, North Carolina. This regulation temporarily changes the
enforcement location to latitude 35[deg]32'25'' N, longitude
077[deg]03'42'' W. The temporary safety zone will be enforced from 7:30
p.m. to 10:30 p.m. on June 8, 2012 and July 4, 2012, and will restrict
general navigation in the regulated area during the event. The Town of
Washington, North Carolina, which is the sponsor for these events,
holds these events annually. Except for participants and vessels
authorized by the Coast Guard Patrol Commander, no person or vessel
will be allowed to enter or remain in the regulated area. These
regulations are needed to control vessel traffic during

the event to enhance the safety of participants, spectators and
transiting vessels.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of that Executive Order 12866
or under section 1 of Executive Order 13563. The Office of Management
and Budget has not reviewed it under that those Orders.
    Although this proposed regulation will restrict access to the area,
the effect of this rule will not be significant because: (i) the safety
zone will only be in effect from 7:30 p.m. to 10 p.m. on June 8, 2012
and July 4, 2012, (ii) the Coast Guard will give advance notification
via maritime advisories so mariners can adjust their plans accordingly,
and (iii) although the safety zone will apply to the section of the
Pamlico River and Tar River, vessel traffic will be able to transit
safely around the safety zone.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    This proposed rule will affect the following entities, some of
which may be small entities: the owners or operators of vessels
intending to transit the specified portion of Pamlico River and Tar
River from 7:30 p.m. to 10 p.m. on June 8, 2012 and July 4, 2012.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
proposed rule will only be in effect for three and a half hours each
day from 7:30 p.m. to 10 p.m. Although the safety zone will apply to a
section of the Pamlico River, vessel traffic will be able to transit
safely around the safety zone. Before the effective period, the Coast
Guard will issue maritime advisories widely available to the users of
the waterway.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact CWO3 Joseph Edge, Waterways
Management Division Chief, Sector North Carolina, at<PHONE_NUMBER>.
The Coast Guard will not retaliate against small entities that question
or complain about this proposed rule or any policy or action of the
Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15

U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under ADDRESSES.
    This proposed rule involves implementation of regulations at 33 CFR
Part 165 that establish safety zones on navigable waters of the United
States for fireworks events. These safety zones are enforced for the
duration of fireworks display events. The fireworks are launched from
or immediately adjacent to navigable waters of the United States and
may have potential for negative impact on the safety or other interest
of waterway users and near shore activities in the event area. The
category of activities includes fireworks launched from barges at or
near the shoreline that generally rely on the use of navigable waters
as a safety buffer.
    This proposed rule is categorically excluded, under figure 2-1,
paragraph (34)(g), of this instruction. This rule establishes a
temporary safety zone to protect the public from fireworks fallout. An
environmental analysis checklist and a preliminary categorical
exclusion determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.
    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    1. The authority citation for part 165 continues to read as
follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

    2. Sec.  165.506, in the Table to Sec.  165.506, make the following
amendments:
    a. Under ``(d) Coast Guard Sector North Carolina-COTP Zone,''
suspend entry 7, which will be enforced from June 7, 2012 through June
9, 2012, and from July 3, 2012 through July 8, 2012.
    b. Under ``(d) Coast Guard Sector North Carolina-COTP Zone,'' add
entry 14 from June 7, 2012 through July 8, 2012, which will be enforced
from 7:30 p.m. to 10 p.m. on June 8, 2012 and from 7:30 p.m. to 10 p.m.
on July 4, 2012, to read as follows:

Sec.  165.506  Safety Zones; Fifth Coast Guard District Fireworks
Displays.

* * * * *

----------------------------------------------------------------------------------------------------------------
    Number                 Date                         Location                        Regulated Area
----------------------------------------------------------------------------------------------------------------
                                (d.) Coast Guard Sector North Carolina--COTP Zone
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
14............  June 8, 2012, July 4, 2012  Pamlico River and Tar River,     All waters of Pamlico River and Tar
                                             Washington, NC, Safety Zone.     River within a 300 yard radius of
                                                                              latitude 35[deg]32'25'' N,
                                                                              longitude 077[deg]03'42'' W, a
                                                                              position located on the southwest
                                                                              shore of the Pamlico River,
                                                                              Washington, NC.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 20, 2012.
Anthony Popiel,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2012-5493 Filed 3-12-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 136 (Monday, July 18, 2022)]
[Notices]
[Pages 42728-42729]
[FR Doc No: 2022-15244]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-2955 (formerly 1999D-4071)]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Impurities: Residual Solvents in New Veterinary Medicinal Products,
Active Substances and Excipients (Revision 2); Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #100 (VICH GL
18(R2)) entitled ``Impurities: Residual Solvents in New Veterinary
Medicinal Products, Active Substances and Excipients (Revision 2).''
This draft guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). The objective
of this draft guidance is to recommend acceptable amounts for residual
solvents in pharmaceuticals for the safety of the target animal as well
as for the safety of residues in products derived from treated food-
producing animals. This revision updates the listings and
classification of solvents.

DATES: Submit either electronic or written comments on the draft
guidance by September 16, 2022 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-1999-D-2955 (formerly 1999D-4071) for ``Impurities: Residual
Solvents in New Veterinary Medicinal Products, Active Substances and
Excipients (Revision 2).'' 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, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    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 draft guidance to
the Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, 7500 Standish Pl., Rockville, MD 20855. Send one self-
addressed adhesive label to assist that office in processing your
request or include a fax number to which the draft guidance may be
sent. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft GFI #100 (VICH
GL18(R2)) entitled ``Impurities: Residual Solvents in New Veterinary
Medicinal Products, Active Substances and Excipients (Revision 2).''
Residual solvents in pharmaceuticals are defined in the guidance as
organic volatile chemicals that are used or produced in the manufacture
of active substances or

excipients, or in the preparation of veterinary medicinal products. The
solvents are not completely removed by practical manufacturing
techniques. The objective of this draft guidance is to recommend
acceptable amounts for residual solvents in pharmaceuticals for the
safety of the target animal as well as for the safety of residues in
products derived from treated food-producing animals. The draft
guidance recommends use of less toxic solvents and describes levels
considered to be toxicologically acceptable for some residual solvents.
This revision updates the listings and classification of solvents.
    FDA has participated in efforts to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify, and then reduce, differences in technical
requirements for drug development among regulatory agencies in
different countries.
    FDA has actively participated in the International Conference on
Harmonization of Technical Requirements for Approval of Pharmaceuticals
for Human Use to develop harmonized technical requirements for the
approval of human pharmaceutical and biological products among the
European Union, Japan, and the United States. The VICH is a parallel
initiative for veterinary medicinal products. The VICH is concerned
with developing harmonized technical requirements for the approval of
veterinary medicinal products in the European Union, Japan, and the
United States, and includes input from both regulatory and industry
representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency;
International Federation for Animal Health--Europe; FDA--Center for
Veterinary Medicine and U.S. Department of Agriculture--Center for
Veterinary Biologics; the U.S. Animal Health Institute; the Japanese
Veterinary Products Association, and the Japanese Ministry of
Agriculture, Forestry, and Fisheries.
    There are eight observers to the VICH Steering Committee: One
representative from government and one representative from industry of
Australia, New Zealand, Canada, and South Africa. The World
Organisation for Animal Health is an associate member of the VICH. The
VICH Secretariat, which coordinates the preparation of documentation,
is provided by the International Federation of Animal Health.
    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 current thinking of FDA on ``Impurities:
Residual Solvents in New Veterinary Medicinal Products, Active
Substances and Excipients (Revision 2).'' 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.

II. Paperwork Reduction Act of 1995

    While this draft guidance contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in section 512(n)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(n)(1)) have been approved under OMB
control number 0910-0669; the collections of information in 21 CFR part
514 have been approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15244 Filed 7-15-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Rules and Regulations]
[Pages 22194-22196]
[FR Doc No: 2016-08510]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R09-OAR-2014-0636; FRL-9944-93-Region 9]

Adequacy Status of Motor Vehicle Emissions Budgets in Submitted
PM2.5 Moderate Area Plan for San Joaquin Valley; California

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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SUMMARY: The Environmental Protection Agency (EPA) is notifying the
public that the Agency has found that the motor vehicle emissions
budgets (MVEBs or ``budgets'') for the years 2014 and 2017 in the San
Joaquin Valley Moderate Area Plan, as revised in a

December 29, 2014 submittal, for the 2006 24-hour fine particulate
(PM2.5) national ambient air quality standards (NAAQS) are
adequate for transportation conformity purposes. The Moderate Area Plan
was submitted to the EPA on March 4, 2013 by the California Air
Resources Board (CARB) as a revision to the California State
Implementation Plan (SIP) and includes a demonstration of reasonable
further progress for the 2006 PM2.5 NAAQS. CARB submitted a
Supplement to the Moderate Area Plan on November 6, 2014 (``2014
Supplement'') and a revision to the budgets on December 29, 2014. We
refer to these submittals collectively as the ``2012 PM2.5
Plan'' or ``Plan.'' Upon the effective date of this notice of adequacy,
the San Joaquin Valley metropolitan planning organizations (MPO) and
the U.S. Department of Transportation (DOT) must use these budgets for
future transportation conformity determinations.

DATES: This finding is effective May 2, 2016.

FOR FURTHER INFORMATION CONTACT: Wienke Tax, U.S. EPA, Region IX, Air
Division AIR-2, 75 Hawthorne Street, San Francisco, CA 94105-3901;
(415) 947-4192 or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA.
    This action is simply an announcement of a finding that we have
already made. EPA Region IX sent a letter to CARB on April 1, 2016
stating that the motor vehicle emissions budgets in the submitted 2012
PM2.5 Plan for the reasonable further progress (RFP)
milestone years of 2014 and 2017 are adequate.
    In response to an October 7, 2014 request by CARB for parallel
processing of the revised budgets in the 2012 PM2.5 Plan,\1\
we announced the availability of the revised budgets on the EPA's
adequacy review Web page at http://www.epa.gov/otaq/stateresources/transconf/currsips.htm from October 23, 2014 to November 24, 2014. We
received no comments on the budgets during this period.
---------------------------------------------------------------------------

    \1\ See letter dated October 7, 2014, from Richard Corey,
Executive Officer, CARB, to Jared Blumenfeld, Regional
Administrator, EPA Region 9.
---------------------------------------------------------------------------

    On January 13, 2015, we proposed to approve these budgets as part
of our proposed action on the 2012 PM2.5 Plan and 2014
Supplement.\2\ We received two comments on the budgets.\3\ We respond
to the first of these two comments below. The second comment concerns
the transportation conformity interpollutant trading mechanism in the
2012 PM2.5 Plan that we proposed to approve for use in
transportation conformity analyses. We will respond to this comment
when we take final action on the interpollutant trading mechanism as
part of our final action on the 2012 PM2.5 Plan and 2014
Supplement. The interpollutant trading mechanism cannot be used until
it is approved as part of the SIP. Therefore, the appropriate venue for
responding to the comment on the trading mechanism is the final rule on
the 2012 PM2.5 Plan and 2014 Supplement.
---------------------------------------------------------------------------

    \2\ 80 FR 1816 at 1841 (January 13, 2015).
    \3\ See letter dated February 27, 2015, from Paul Cort and
Adenike Adeyeye, Earthjustice, to Wienke Tax, Air Planning Office,
EPA Region 9.
---------------------------------------------------------------------------

    Transportation conformity is required by Clean Air Act section
176(c). The EPA's conformity rule requires that transportation plans,
transportation improvement programs, and projects conform to a SIP and
establishes the criteria and procedures for determining whether or not
they do. Conformity to a SIP means that transportation activities will
not produce new air quality violations, worsen existing violations, or
delay timely attainment of the NAAQS.
    The criteria by which we determine whether a SIP's MVEBs are
adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4)
which was promulgated in our August 15, 1997 final rule (62 FR 43780 at
43781-43783). We have further described our process for determining the
adequacy of submitted SIP MVEBs in our July 1, 2004 final rule (69 FR
40004 at 40038), and we used the information in these resources in
making our adequacy determination. Please note that an adequacy review
is separate from the EPA's completeness review and should not be used
to prejudge the EPA's ultimate action on the SIP. Even if we find a
budget adequate, the SIP could later be disapproved.

Response to Comment

    Comment: Earthjustice asserts that the EPA must disapprove the RFP
demonstration in the 2012 PM2.5 Plan and 2014 Supplement
because it does not adequately address ammonia emission reductions and,
therefore, does not provide ``such annual incremental reductions in
emissions of the relevant air pollutant as are required . . . for the
purpose of ensuring attainment . . . by the applicable date.''
Earthjustice argues that, because the RFP demonstration is not
approvable, the EPA cannot find that the motor vehicle emissions
budgets in the 2012 PM2.5 Plan and 2014 Supplement are
consistent with applicable requirements for reasonable further
progress, as required by 40 CFR 98.118(e)(4)(iv).
    Response: On January 13, 2015, the EPA proposed to approve several
elements of the 2012 PM2.5 Plan and 2014 Supplement, which
California submitted to address Clean Air Act requirements for the 2006
PM2.5 NAAQS in the San Joaquin Valley.\4\ As part of this
action, the EPA proposed to approve the Plan's RFP demonstration for
2014 and 2017, based on a conclusion that the 2014 and 2017 emissions
projections for direct PM2.5, nitrogen oxides
(NOX), sulfur dioxide (SO2), and ammonia
(NH3) reflect full implementation of the State's and
District's Reasonably Available Control Measures/Reasonably Available
Control Technology control strategy, which achieves substantial
reductions in emissions of each of these pollutants over the period
covered by the Plan. Id. at 1835-37. The EPA also proposed to approve
the direct PM2.5 and NOX MVEBs for 2014 and 2017,
based on a conclusion that these MVEBs are consistent with applicable
requirements for reasonable further progress and the other adequacy
requirements. Id. at 1838-41. Finally, in accordance with 40 CFR
93.102(b)(2)(v), the EPA proposed to find that on-road emissions of
volatile organic compounds (VOC), SO2, and NH3
are not significant contributors to the PM2.5 nonattainment
problem in the SJV area, and accordingly, that transportation
conformity requirements do not apply for these pollutants in this area.
Id. at 1840.
---------------------------------------------------------------------------

    \4\ See 80 FR 1816 (January 13, 2015).
---------------------------------------------------------------------------

    In PM2.5 nonattainment areas, the transportation
conformity provisions of 40 CFR part 93, subpart A, apply with respect
to emissions of VOC, SO2 and/or NH3 if the EPA
Regional Administrator or the director of the state air agency has made
a finding that on-road emissions of any of these precursors within the
nonattainment area are a significant contributor to the
PM2.5 nonattainment problem and has so notified the MPO and
DOT, or if the applicable implementation plan (or implementation plan
submission) establishes an approved (or adequate) budget for such
emissions as part of the reasonable further progress, attainment or
maintenance strategy. 40 CFR 93.102(b)(2)(v). With respect to VOC,
SO2, and NH3, neither the EPA nor the State has
made a finding that on-road emissions of any of these precursors are

a significant contributor to the PM2.5 nonattainment problem
in the SJV area, and neither the approved California SIP nor the
submitted 2012 PM2.5 Plan and 2014 Supplement establish
adequate MVEBs for such emissions as part of an RFP, attainment or
maintenance strategy for the PM2.5 NAAQS. Accordingly, the
transportation conformity provisions of 40 CFR part 93, subpart A, do
not apply with respect to emissions of VOC, SO2 or
NH3 for purposes of the 2006 PM2.5 NAAQS in the
SJV.
    The provisions of 40 CFR part 93, subpart A, apply with respect to
emissions of NOX because neither the EPA nor the State has
made a finding that on-road emissions of NOX within the SJV
nonattainment are not a significant contributor to the PM2.5
nonattainment problem, and because the 2012 PM2.5 Plan and
2014 Supplement establish adequate budgets for such emissions as part
of the Plan's RFP strategy. 40 CFR 93.102(b)(2)(iv). The provisions of
40 CFR part 93, subpart A, also apply with respect to emissions of
direct PM2.5 because PM2.5 is a criteria
pollutant identified in 40 CFR 93.102(b)(1).
    In order to find an MVEB in a submitted control strategy
implementation plan revision to be adequate for transportation
conformity purposes, the EPA must find, among other things, that the
motor vehicle emissions budget(s), when considered together with all
other emission sources, is consistent with applicable requirements for
reasonable further progress, attainment, or maintenance (whichever is
relevant to the given plan). 40 CFR 93.118(e)(4)(iv). Because the
provisions of 40 CFR part 93, subpart A, apply only with respect to
emissions of NOX and direct PM2.5 for purposes of
the 2006 PM2.5 NAAQS in the SJV area, we have evaluated the
submitted NOX and direct PM2.5 MVEBs for
consistency with our adequacy criteria in Sec.  93.118(e)(4). The
commenter's arguments about NH3 emissions are not germane to
our evaluation of the MVEBs under these adequacy criteria.
    As explained in our January 13, 2015 proposed rule, the 2014 and
2017 MVEBs for NOX and direct PM2.5 in the 2012
PM2.5 Plan and 2014 Supplement are consistent with the RFP
demonstration with respect to these pollutants in the submitted plan.
We find, therefore, that these MVEBs meet the requirement in 40 CFR
93.118(e)(4) for consistency with applicable requirements for RFP in
the submitted plan. We note that our adequacy review is a cursory
review of the SIP and MVEBs to ensure that the minimum adequacy
criteria are met before a submitted budget is used in a conformity
determination. This adequacy finding should not be used to prejudge the
EPA's final rulemaking action on the SIP.
    In summary, we are announcing our finding that the motor vehicle
emissions budgets for the years 2014 and 2017 from the 2012
PM2.5 Plan are adequate for transportation conformity
purposes. The finding is available at the EPA's conformity Web site:
http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm. The
adequate MVEBs are provided in the following table:

                  Adequate MVEBs in the San Joaquin Valley for the 2006 24-Hour PM2.5 Standards
                                         [Winter daily average in tons]
----------------------------------------------------------------------------------------------------------------
                                                               2014                            2017
                     County                      ---------------------------------------------------------------
                                                       PM2.5            NOX            PM2.5            NOX
----------------------------------------------------------------------------------------------------------------
Fresno..........................................             1.0            31.6             0.9            25.2
Kern (SJV)......................................             1.2            43.2             1.0            34.4
Kings...........................................             0.2             8.8             0.2             7.2
Madera..........................................             0.3             8.7             0.2             7.0
Merced..........................................             0.5            17.2             0.4            13.7
San Joaquin.....................................             0.7            20.0             0.6            15.9
Stanislaus......................................             0.5            15.1             0.5            12.0
Tulare..........................................             0.5            14.3             0.4            10.7
                                                 ---------------------------------------------------------------
    Total *.....................................             4.9           159.0             4.3           126.0
----------------------------------------------------------------------------------------------------------------
Source: Letter, Richard Corey, Executive Officer, CARB, to Jared Blumenfeld, Regional Administrator, EPA Region
  9, dated December 29, 2014, and Staff Report, Appendix A, Table C-4.
* Totals reflect disaggregated emissions and may not add exactly as shown here due to rounding. Letter, Richard
  Corey, Executive Officer, CARB, to Jared Blumenfeld, Regional Administrator, EPA Region 9, dated December 29,
  2014, Staff Report with Attachment, revised Table C-4, ``Transportation Conformity Budgets'' to 2012 PM2.5
  Plan.

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

     Dated: April 1, 2016.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2016-08510 Filed 4-14-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: April 17, 2006 (Volume 71, Number 73)]
[Notices]
[Page 19723]
[DOCID:fr17ap06-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2230-034]

City and Borough of Sitka, AK; Notice of Application Tendered for
Filing With the Commission, Establishing Procedural Schedule for
Relicensing, and a Deadline for Submission of Final Amendments

April 10, 2006.
    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.: 2230-034.
    c. Date Filed: March 28, 2006.
    d. Applicant: City and Borough of Sitka, Alaska.
    e. Name of Project: Blue Lake Hydroelectric Project.
    f. Location: On the Sawmill Creek, 5 miles southeast of the City of
Sitka, Alaska. The project occupies land of the United States
administered by the Forest Service.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Charles Walls, Utility Director, City and
Borough of Sitka, 105 Jarvis Street, Sitka, AK 99835,<PHONE_NUMBER>.
    i. FERC Contact: Thomas Dean,<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    j. Cooperating agencies: We are asking Federal, state, local, and
tribal agencies with jurisdiction and/or special expertise with respect
to environmental issues to cooperate with us in the preparation of the
environmental document. Agencies who would like to request cooperating
status should follow the instructions for filing such requests
described in item l below. Cooperating agencies should note the
Commission's policy that agencies that cooperate in the preparation of
the environmental document cannot also intervene. See, 94 FERC ] 61,076
(2001).
    k. Deadline for requesting cooperating agency status: May 30, 2006.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    Requests for cooperating agency status may be filed electronically
via the Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the

``eFiling'' link.
    l. This application is not ready for environmental analysis at this
time.
    m. The existing Blue Lake Project consists of one development and
two units as follows: The Blue Lake development consists of: (1) A 211-
foot-high, 256-foot-long concrete arch dam equipped with a 140-foot-
long spillway and a release valve at the base of the dam; (2) a 1,225-
acre reservoir with a normal water surface elevation of 342 feet msl;
(3) a 7,110-foot-long power conduit consisting of: (a) An 11.5-foot-
diameter, 1,500-foot-long penstock; (b) an 84-inch-diameter, 460-foot-
long penstock; (c) a 10-inch-diameter, 4,650-foot-long lower penstock;
(d) an 84-inch-diameter, 500-foot-long penstock; (e) a 20-inch-diameter
water supply tap; (f) an 84-inch-diameter butterfly valve; and (g) a
24-inch conduit drain valve; (4) a powerhouse containing two 3,000 kW
generating units; (5) a 150-foot-long tailrace; (6) a 5-mile-long, 69-
kV transmission line; and (7) appurtenant facilities.
    The Fish Valve Unit consists of: (1) A 36-inch-diameter wye
penstock connected to the power conduit; (2) a powerhouse containing
one 670 kW generating unit; (3) a 7,700-foot-long, 12.47-kV
transmission line; and (4) appurtenant facilities.
    The Pulp Mill Feeder Unit consists of: (1) A 36-inch-diameter tee
connected to the power conduit; (2) a 36-inch-diameter, 24-foot-long
penstock; (3) a powerhouse containing one 870 kW generating unit; (4) a
470-foot-long 4.16-kV transmission line; and (5) other appurtenant
facilities.
    n. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at 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. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    o. With this notice, we are initiating consultation with the Alaska
State Historic Preservation Officer (SHPO), as required by Sec.  106,
National Historic Preservation Act, and the regulations of the Advisory
Council on Historic Preservation, 36 CFR 800.4.
    p. Procedural schedule and final amendments: The application will
be processed according to the following Hydro Licensing Schedule.
Revisions to the schedule will be made as appropriate. The Commission
staff proposes to issue one environmental assessment rather than issue
a draft and final EA. Comments, terms and conditions, recommendations,
prescriptions, and reply comments, if any, will be addressed in an EA.
Staff intends to give at least 30 days for entities to comment on the
EA, and will take into consideration all comments received on the EA
before final action is taken on the license application.

Issue Acceptance or Deficiency Letter.....  May 2006.
Request Additional Information, if needed.  May 2006.
Notice Soliciting Final Terms and           Aug. 2006.
 Conditions.
Notice of the availability of the EA......  Jan. 2007.
Ready for Commission's decision on the      March 2007.
 application.

    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
soliciting final terms and conditions.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5618 Filed 4-14-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Notices]
[Page 53072]
[FR Doc No: 2018-22855]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0923]

Certificate of Alternative Compliance for the Blount Boats Inc.,
Hull TGI-329

AGENCY: Coast Guard, DHS.

ACTION: Notification of issuance of a certificate of alternative
compliance.

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

SUMMARY: The Coast Guard announces that the U.S. Coast Guard First
District Prevention Department has issued a certificate of alternative
compliance from the International Regulations for Preventing Collisions
at Sea, 1972 (72 COLREGS), for the Blount Boats Inc., Hull TGI-329. We
are issuing this notice because its publication is required by statute.
Due to the construction and placement of the vessel's side lights, Hull
TGI-329 cannot fully comply with the light, shape, or sound signal
provisions of the 72 COLREGS without interfering with the vessel's
design and construction. This notification of issuance of a certificate
of alternative compliance promotes the Coast Guard's marine safety
mission.

DATES: The Certificate of Alternative Compliance was issued on October
15, 2018.

FOR FURTHER INFORMATION CONTACT: For information or questions about
this notice call or email Mr. Kevin Miller, First District Towing
Vessel/Barge Safety Specialist, U.S. Coast Guard; telephone (617) 223-
8272, email [email protected].

SUPPLEMENTARY INFORMATION: The United States is a signatory to the
International Maritime Organization's International Regulations for
Preventing Collisions at Sea, 1972 (72 COLREGS), as amended. The
special construction or purpose of some vessels makes them unable to
comply with the light, shape, or sound signal provisions of the 72
COLREGS. Under statutory law, however, specified 72 COLREGS provisions
are not applicable to a vessel of special construction or purpose if
the Coast Guard determines that the vessel cannot comply fully with
those requirements without interfering with the special function of the
vessel.\1\
---------------------------------------------------------------------------

    \1\ 33 U.S.C. 1605.
---------------------------------------------------------------------------

    The owner, builder, operator, or agent of a special construction or
purpose vessel may apply to the Coast Guard District Office in which
the vessel is being built or operated for a determination that
compliance with alternative requirements is justified,\2\ and the Chief
of the Prevention Division would then issue the applicant a certificate
of alternative compliance (COAC) if he or she determines that the
vessel cannot comply fully with 72 COLREGS light, shape, and sound
signal provisions without interference with the vessel's special
function.\3\ If the Coast Guard issues a COAC, it must publish notice
of this action in the Federal Register.\4\
---------------------------------------------------------------------------

    \2\ 33 CFR 81.5.
    \3\ 33 CFR 81.9.
    \4\ 33 U.S.C. 1605(c) and 33 CFR 81.18.
---------------------------------------------------------------------------

    The First District Prevention Department, U.S. Coast Guard,
certifies that the Blount Boats Inc., Hull TGI-329 is a vessel of
special construction or purpose, and that, with respect to the position
of the vessels side light, it is not possible to comply fully with the
requirements of the provisions enumerated in the 72 COLREGS, without
interfering with the normal operation, construction, or design of the
vessel. The First District Prevention Department further finds and
certifies that the vessel's sidelights (12' 1.67'' from the vessel's
side mounted on the pilot house) are in the closest possible compliance
with the applicable provisions of the 72 COLREGS.\5\
---------------------------------------------------------------------------

    \5\ 33 U.S.C. 1605(a); 33 CFR 81.9.
---------------------------------------------------------------------------

    This notice is issued under authority of 33 U.S.C. 1605(c) and 33
CFR 81.18.

    Dated: October 16, 2018.
Richard J. Schultz,
Captain, U.S. Coast Guard, Chief, Prevention Division, First Coast
Guard District.
[FR Doc. 2018-22855 Filed 10-18-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Rules and Regulations]
[Pages 55041-55044]
[FR Doc No: 2019-22323]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0693; Product Identifier 2017-NE-43-AD; Amendment
39-19758; AD 2019-20-05]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
(Type Certificate Previously Held by Rolls-Royce plc) Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is superseding airworthiness directive (AD) 2018-15-01
for certain Rolls-Royce plc (RR) Trent 1000-A, Trent 1000-C, Trent
1000-D, Trent 1000-E, Trent 1000-G, Trent 1000-H, Trent 1000-A2, Trent
1000-C2, Trent 1000-D2, Trent 1000-E2, Trent 1000-G2, Trent 1000-H2,
Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2 model turbofan engines.
AD 2018-15-01 required certain engines susceptible to intermediate-
pressure turbine (IPT) blade failure not be installed on an airplane
together with other engines with IPT blades of the same cyclic life.
This AD requires removal of the IPT blade set at lower cyclic life
limits and replacing it with a blade set eligible for installation.
This AD also expands the applicability to include additional Trent 1000
turbofan engine models. This AD was prompted by the determination that
certain IPT blades are susceptible to shank corrosion which leads to
cracking and possible blade separation. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective October 30, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 30,
2019.
    The FAA must receive any comments on this AD by November 29, 2019.

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 http://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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Rolls-Royce
plc, Corporate Communications, P.O. Box 31, Derby, England, DE24 8BJ;
phone: 011-44-1332-242424; fax: 011-44-1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; internet: https://customers.rolls-royce.com/public/rollsroycecare. You may view this
service information at the FAA, Engine and Propeller Standards Branch,
1200 District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2019-0693.

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-2019-
0693; 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 AD, the mandatory continuing airworthiness information (MCAI),
regulatory evaluation, any comments received, and other information.
The street address for Docket Operations is listed above. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Martin Adler, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7088; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued AD 2018-15-01, Amendment 39-19333 (83 FR 34755, July
23, 2018), (``AD 2018-15-01''), for certain RR Trent 1000-A, Trent
1000-C, Trent 1000-D, Trent 1000-E, Trent 1000-G, Trent 1000-H, Trent
1000-A2, Trent 1000-C2, Trent 1000-D2, Trent 1000-E2, Trent 1000-G2,
Trent 1000-H2, Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2 model
turbofan engines. AD 2018-15-01 prohibited the installation of engines
susceptible to IPT blade failure on an airplane together with other
engines with IPT blades of the same cyclic life. AD 2018-15-01 resulted
from new operating restrictions

for engines with IPT blades susceptible to shank corrosion and possible
blade separation. The FAA issued AD 2018-15-01 to prevent the
simultaneous failure of both engines.

Actions Since AD 2018-15-01 Was Issued

    Since the FAA issued AD 2018-15-01, RR determined that unless new
IPT blades are installed in accordance with RR Service Bulletin (SB)
Trent 1000 72-H818, dated November 14, 2016, or RR SB Trent 1000 72-
J559, dated November 27, 2017, each engine must remain subject to
specific maintenance intervals to minimize the risk of IPT blade
release. Both SBs introduced new IPT blades not subject to this AD. RR
SB Trent 1000 72-J559 also applies to additional RRD Trent 1000 engines
(Trent 1000 TEN engine standard). RR subsequently transferred its FAA
type certificate for the subject model engines to Rolls-Royce
Deutschland Ltd & Co KG (RRD).
    Also, since the FAA issued AD 2018-15-01, the European Union
Aviation Safety Agency (EASA) issued EASA AD No. 2019-0135, dated June
11, 2019 (referred to after this as the Mandatory Continuing
Airworthiness Information, or the ``MCAI''). The MCAI states:
    Occurrences were reported of IPTB [IPT blade] shank cracking.
Analysis shows that this kind of failure is due to sulphidation
corrosion.
    This condition, if not corrected, could lead to IPTB shank release,
possibly resulting in engine in-flight shut-down (IFSD) and consequent
reduced control of the aeroplane.
    Prompted by these events, Rolls-Royce identified engines with a
high level of sulphidation exposure using a corrosion fatigue life
(CFL) model. Consequently, EASA issued AD 2017-0056 to require removal
from service of certain engines, to be corrected in shop. In addition,
to reduce the risk of dual IFSD, it was decided to introduce a new
cyclic life limit to certain engines, determining when an engine can no
longer be installed on an aeroplane in combination with certain other
engines. Consequently, EASA issued Emergency AD 2017-0253-E, AD 2018-
0086, and finally AD 2018-0139, each next AD superseding the previous
one, to require de-pairing of the affected engines.
    After EASA AD 2018-0139 was issued, prompted by further analyses of
data provided by operators, Rolls-Royce developed an updated service
management approach to minimise the risk of IPTB release and issued the
NMSB, identifying those ESN at highest risk, and providing the
corresponding cyclic limits for in-shop IPTB replacement. Consequently,
EASA issued AD 2018-0257, superseding EASA AD 2017-0056 and AD 2018-
0139, to require removal from service of certain engines, to be
corrected in shop. That AD also required, for engines having SUM IPTB
installed, the introduction of IPTB cyclic limits. Finally, that AD
retained the optional terminating action as previously provided by EASA
AD 2018-0139.
    Since that AD was issued, it was determined that, unless mod/SB 72-
H818 or mod/SB 72-J559 is embodied, each engine must remain subject to
service management to minimise the risk of IPTB release. Rolls-Royce
mod/SB 72-J559 applies to the Trent 1000 TEN engine standard,
introducing IPTB P/N KH71526 and additional IPTB coating.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2018-0257, which is superseded, expands the
Applicability by including Trent 1000 TEN engine models, and including
reference to the NMSB, as defined in this AD.
    You may obtain further information by examining the MCAI in the AD
docket on the internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2019-0693.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed RR Alert Non-Modification Service Bulletin (NMSB)
Trent 1000 72-AK186, Revision 2, dated April 16, 2019. This service
information establishes cyclic life limits for IPT blades and specifies
removing RRD Trent 1000 engines with IPT blades that have a cyclic life
exceeding the new cyclic life limits.
    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.

Other Related Service Information

    The FAA reviewed RR NMSB Trent 1000 72-J442, Revision 3, dated
October 8, 2018, and RR NMSB Trent 1000 72-J465, Revision 4, dated
October 8, 2018. These NMSBs both describe procedures, as applicable to
different sets of RRD Trent 1000 model turbofan engines, for cleaning
and inspecting affected IPT blades so that they are suitable for reuse.
    The FAA also reviewed RR SB Trent 1000 72-H818, dated November 14,
2016, and RR SB Trent 1000 72-J559, dated November 27, 2017. RR SB
Trent 1000 72-H818 introduced a new IPT blade that is less susceptible
to shank corrosion. RR SB Trent 1000 72-J559 introduced a new IPT blade
with additional blade coating and applies to additional Trent 1000
engines (Trent 1000 TEN engine standard).

FAA's Determination

    This product has been approved by EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Union, EASA has notified us of the unsafe condition
described in the MCAI and service information referenced above. The FAA
is issuing this AD because it evaluated all the relevant information
provided by EASA and determined the unsafe condition described
previously is likely to exist or develop in other products of the same
type design.

AD Requirements

    This AD requires removal of the IPT blade set at lower cyclic life
limits and its replacement with a blade set eligible for installation
for affected RRD Trent 1000 model turbofan engines.

FAA's Justification and Determination of the Effective Date

    No domestic operators use this product. Therefore, the FAA finds
that notice and opportunity for prior public comment are unnecessary.
In addition, for this same reason, the FAA finds that good cause exists
for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and the FAA did not provide you with notice and an opportunity
to provide your comments before it becomes effective. However, the FAA
invites you to send any written data, views, or arguments about this
final rule. Send your comments to an address listed under the ADDRESSES
section. Include the docket number FAA-2019-0693 and product identifier
2017-NE-43-AD at the beginning of your comments. The FAA specifically
invites comments on the overall regulatory, economic, environmental,
and energy aspects of this final rule. The FAA will consider all
comments received by the closing date and may amend this final rule
because of those comments.
    The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this final rule.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 0 engines installed on
airplanes of U.S. registry.
    In the event an affected engine becomes installed on a U.S.-
registered product, the FAA estimates the following costs to comply
with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replace IPT blades.................  48 work-hours x $85 per            $100,000        $104,080              $0
                                      hour = $4,080.
----------------------------------------------------------------------------------------------------------------

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.
    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 engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation 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, and
    (2) Will not affect intrastate aviation in Alaska.

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 part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2018-15-01, Amendment 39-19333 (83 FR 34755, July 23, 2018), and adding
the following new AD:

2019-20-05 Rolls-Royce Deutschland Ltd & Co KG (Type Certificate
previously held by Rolls-Royce plc) Turbofan Engines: Amendment 39-
19758; Docket No. FAA-2019-0693; Product Identifier 2017-NE-43-AD.

(a) Effective Date

    This AD is effective October 30, 2019.

 (b) Affected ADs

    This AD replaces AD 2018-15-01, Amendment 39-19333 (83 FR 34755,
July 23, 2018).

 (c) Applicability

    This AD applies to Rolls-Royce Deutschland Ltd. & Co KG (Type
Certificate previously held by Rolls-Royce plc) (RRD) Trent 1000-A,
Trent 1000-A2, Trent 1000-AE, Trent 1000-AE2, Trent 1000-AE3, Trent
1000-C, Trent 1000-C2, Trent 1000-CE, Trent 1000-CE2, Trent 1000-
CE3, Trent 1000-D, Trent 1000-D2, Trent 1000-D3, Trent 1000-E, Trent
1000-E2, Trent 1000-G, Trent 1000-G2, Trent 1000-G3, Trent 1000-H,
Trent 1000-H2, Trent 1000-H3, Trent 1000-J2, Trent 1000-J3, Trent
1000-K2, Trent 1000-K3, Trent 1000-L2, Trent 1000-L3, Trent 1000-M3,
Trent 1000-N3, Trent 1000-P3, Trent 1000-Q3 and Trent 1000-R3 model
turbofan engines, with an engine serial number (ESN) listed in
Appendix 1, 2, or 3 of Rolls-Royce plc (RR) Alert Non-Modification
Service Bulletin (NMSB) Trent 1000 72-AK186, Revision 2, dated April
16, 2019, except those engines that have incorporated the
modifications in RR Service Bulletin (SB) Trent 1000 72-H818, dated
November 14, 2016, or RR SB Trent 1000 72-J559, dated November 27,
2017.

 (d) Subject

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

 (e) Unsafe Condition

    This AD was prompted by the determination that certain
intermediate-pressure turbine (IPT) blades are susceptible to shank
corrosion which leads to cracking and possible blade separation. The
FAA is issuing this AD to prevent the simultaneous failure of both
engines installed on an airplane, during flight. The unsafe
condition, if not addressed, could result in a dual engine in-flight
shutdown and loss of the airplane.

 (f) Compliance

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

 (g) Required Actions

    (1) For engines with an ESN listed in Appendix 1 of RR Alert
NMSB Trent 1000 72-AK186, Revision 2, dated April 16, 2019 (``RR
Alert NMSB Trent 1000 72-AK186''), prior to reaching the blade cycle
life limit listed in Appendix 1 of RR Alert NMSB Trent 1000 72-
AK186, or within 30 days of the effective date of this AD, whichever
occurs later, remove the IPT blade set and replace with an IPT blade
set eligible for installation.
    (2) For engines with an ESN listed in Appendix 2 of RR Alert
NMSB Trent 1000 72-AK186:
    (i) If the engine is in an engine shop visit on the effective
date of this AD, remove the IPT blade set and replace with an IPT
blade set eligible for installation prior to returning the engine to
service; or

    (ii) If the engine is not in an engine shop visit on the
effective date of this AD and the IPT blade set was not replaced
during the previous engine shop visit, remove the IPT blade set and
replace with an IPT blade set eligible for installation within 30
days of the effective date of this AD.
    (3) For engines that have replaced the IPT blade set per RR NMSB
Trent 1000 72-J442, Revision 3, dated October 8, 2018, or RR NMSB
Trent 1000 72-J465, Revision 4, dated October 8, 2018, as
applicable, remove and replace those blades prior to reaching the
``Permitted Cycles of operation since installation in accordance
with NMSB 72-J442 or 72-J465'' listed in Appendix 3 of RR Alert NMSB
Trent 1000 72-AK186, as applicable for each ESN, or within 30 days
of the effective date of this AD, whichever occurs later.

    Note 1 to paragraph (g): An IPT blade set eligible for
installation is a full set of new IPT blades, or a full set of
blades that have been inspected per RR NMSB Trent 1000 72-J442,
Revision 3, dated October 8, 2018, or RR NMSB Trent 1000 72-J465
Revision 4, October 8, 2018, as applicable by engine model.

 (h) Definition

    For the purpose of this AD, an ``engine shop visit'' is the
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine case flanges, except that
the separation of engine flanges solely for the purposes of
transportation without subsequent engine maintenance does not
constitute an engine shop visit.

 (i) 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 paragraph (j)(1) of this AD. You may email your
request 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.

 (j) Related Information

    (1) For more information about this AD, contact Martin Adler,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2019-0135, dated June 11, 2019, for more information. You may
examine the EASA AD in the AD docket on the internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2019-0693.

 (k) 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) Rolls-Royce plc (RR) Alert Non-Modification Service Bulletin
Trent 1000 72-AK186, Revision 2, dated April 16, 2019.
    (ii) [Reserved]
    (3) For RR service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-
249936; email: http://www.rolls-royce.com/contact/civil_team.jsp;
internet: https://customers.rolls-royce.com/public/rollsroycecare.
    (4) You may view this service information at FAA, Engine and
Propeller Standards Branch, 1200 District Avenue, Burlington, MA
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, email<EMAIL_ADDRESS>
or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on October 3, 2019.
Robert J. Ganley,
Manager, Engine & Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2019-22323 Filed 10-11-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: January 30, 2006 (Volume 71, Number 19)]
[Notices]
[Page 4906]
[DOCID:fr30ja06-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-63-000; ER06-63-001]

Take Two, LLC; Notice of Issuance of Order

January 23, 2006.
    Take Two, LLC (Take Two) filed an application for market-based rate
authority, with an accompanying rate schedule. The proposed market-
based rate schedule provides for the sales of energy and capacity at
market-based rates. Take Two also requested waiver of various
Commission regulations. In particular, Take Two requested that the
Commission grant blanket approval under 18 CFR part 34 of all future
issuances of securities and assumptions of liability by Take Two.
    On January 20, 2006, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the request
for blanket approval under part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approval of issuances of securities or assumptions of liability by Take
Two should file a motion to intervene or protest with the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is February 21, 2006.
    Absent a request to be heard in opposition by the deadline above,
Take Two is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
Take Two, compatible with the public interest, and is reasonably
necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approval of Take Two's issuances of securities or assumptions
of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-1128 Filed 1-27-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]
[Page 38613-38615]
[DOCID:fr04au09-40]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2008-0300; FRL-8940-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Shipbuilding and Ship
Repair Facilities--Surface Coating (Renewal); EPA ICR Number 1712.06;
OMB Control Number 2060-0330

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved

collection. The ICR which is abstracted below describes the nature of
the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before September 3,
2009.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2008-0300, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28331T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2)
OMB at: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Leonard Lazarus, Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 30, 2008 (73 FR 31088) EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2008-0300, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NESHAP for Shipbuilding and Ship Repair Facilities--Surface
Coating (Renewal).
    ICR Numbers: EPA ICR Number 1712.06, OMB Control Number 2060-0330.
    ICR Status: This ICR is scheduled to expire on August 31, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The respondents are owners or operators of Shipbuilding
and Ship Repair Facilities. Operations covered include: primer and top
coat application in manufacturing processes and in ship repair
processes. The National Emission Standards for Hazardous Air Pollutants
(NESHAP) regulation, 40 CFR part 63, subpart II, was promulgated on
December 15, 1995. Owners or operators of the affected facilities
described must make initial reports when a source becomes subject,
conduct and report on a performance test, demonstrate and report on
continuous monitor performance, and maintain records of the occurrence
and duration of any startup, shutdown, or malfunction in the operation
of an affected facility. Semiannual reports of excess emissions are
required. These notifications, reports, and records are essential in
determining compliance; and are required, in general, of all sources
subject to NESHAP.
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance
reports, and records. All reports are sent to the delegated state or
local authority. In the event that there is no such delegated
authority, the reports are sent directly to the EPA regional office.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9 and are identified on
the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 255
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Owners or operators of shipbuilding
and ship repair facilities.
    Estimated Number of Respondents: 56.
    Frequency of Response: Semiannually, On Occasion, Initially.
    Estimated Total Annual Hour Burden: 28,594 hours.
    Estimated Total Annual Cost: $1,740,381 in labor costs,
exclusively. There are no capital/startup or Operations and Maintenance
costs associated with this ICR.
    Changes in the Estimates: There is no change in the burden hours or
cost to the respondents in this ICR compared to the previous ICR. This
is due to two considerations: (1) the regulations have not changed over
the past three years and are not anticipated to change over the next
three years; and (2) the growth rate for the respondents is very low,
negative or nonexistent. Therefore, the labor hours and cost figures in
the previous ICR reflect the current burden to the respondents and are
reiterated in

this ICR. In the previous ICR, the cost figure was rounded-up to the
nearest thousand. In this ICR, the figure is rounded to the nearest
dollar.

    Dated: July 29, 2009.
John Moses,
Director, Collection Strategies Division.
[FR Doc. E9-18589 Filed 8-3-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Page 77151]
[FR Doc No: 2022-27257]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96477; File No. SR-MRX-2022-22]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of
Withdrawal of Proposed Rule Change To Amend Options 7, Section 7 To Add
Market Data Fees

December 12, 2022.
    On October 14, 2022, Nasdaq MRX, LLC (``MRX'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change to assess market data fees.
The proposed rule change was published for comment in the Federal
Register on October 28, 2022.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 96144 (October 24,
2022), 87 FR 65273.
---------------------------------------------------------------------------

    On December 8, 2022, MRX withdrew the proposed rule change (SR-MRX-
2022-22).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\4\
---------------------------------------------------------------------------

    \4\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-27257 Filed 12-15-22; 8:45 am]
BILLING CODE 8011-01-P


Comment Info: =================

General Comment:I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes.  Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation. I have been smoking cigarettes since I was 12 years old, this is the only product that has effectively helped me to quit. I have used all market approved products to try and quit smoking. and NONE of them was even close to being as helpful as this product!