[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Rules and Regulations]
[Pages 55362-55366]
[FR Doc No: 2023-17575]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1712; Project Identifier MCAI-2023-00821-A;
Amendment 39-22523; AD 2023-16-04]
RIN 2120-AA64

Airworthiness Directives; Piaggio Aviation S.p.A. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Piaggio Aviation S.p.A. (Piaggio) Model P-180 airplanes. This
AD was prompted by a report of corrosion-induced cracking on the
horizontal tail trim actuator (HTTA) fitting assembly. This AD requires
repetitively inspecting the HTTA fitting assembly for corrosion and
cracking until the HTTA fitting assembly is replaced with a new part.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective August 30, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 30,
2023.
    The FAA must receive comments on this AD by September 29, 2023.

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 regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1712; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact Piaggio Aero Industries S.p.A., P180 Customer Support, via
Pionieri e Aviatori d'Italia, snc-16154 Genoa, Italy; phone: +39 331
679 74 93; email: [email protected].
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2023-1712.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aviation Safety Engineer,
FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (816)
329-4144; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2023-1712; Project Identifier MCAI-
2023-00821-A'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Mike
Kiesov, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2023-0122R1, dated July 5, 2023

(referred to after this as the MCAI), to correct an unsafe condition on
certain serial-numbered Piaggio Model P.180 airplanes. The MCAI states
an occurrence was reported where, during scheduled maintenance, stress
corrosion-induced cracking was found on the HTTA fitting assembly. The
MCAI states that this type of corrosion can be found on older
airplanes, based and operated for an extended period of time near the
seaside, exposed to a salty environment, or parked outside in an
environment of high humidity or frequent heavy precipitation.
    To address the unsafe condition, the MCAI requires doing a high
frequency eddy current inspection (HFEC) of the HTTA fitting assembly
for corrosion and cracking and, depending on the findings, repeating
the inspection and repairing any light corrosion, or replacing the HTTA
fitting assembly with a new part. The MCAI states that replacing the
HTTA fitting assembly terminates the repetitive inspections.
    This condition, if not addressed, could result in structural
failure of the HTTA fitting assembly and loss of control of the
airplane. You may examine the MCAI in the AD docket at regulations.gov
under Docket No. FAA-2023-1712.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Piaggio Aerospace Service Bulletin 80-0492,
Revision 3, dated June 12, 2023. This service information specifies
procedures for doing an HFEC inspection of the HTTA fitting assembly
for corrosion and taking corrective actions. The corrective actions
include repeating the HFEC inspection, repairing light corrosion, and
replacing the HTTA fitting assembly with a new part.
    The FAA also reviewed Piaggio Aerospace Temporary Revision TR-031
to Chapter 51-70-70, dated May 29, 2023, to the Piaggio P.180
Structural Repair Manual. This service information specifies procedures
for replacing the HTTA fitting assembly.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES section.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI and service information referenced above. The FAA is issuing
this AD after determining that the unsafe condition described
previously is likely to exist or develop on other products of the same
type design.

AD Requirements

    This AD requires accomplishing the actions specified in the service
information already described, except as discussed under ``Differences
Between this AD and the MCAI.''

Differences Between This AD and the MCAI

    The MCAI allows airplanes with corrosion or cracking in certain
areas of the HTTA fitting assembly to continue flights and be repaired
within 150 hours time-in-service or 7 months, whichever occurs first.
This AD requires that airplanes with corrosion exceeding light
corrosion or with cracking on any part of the HTTA fitting assembly be
repaired before further flight.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies forgoing notice and comment prior to adoption of this rule
because corrosion on the HTTA fitting assembly could lead to cracking
that, if not addressed, could result in structural failure of the HTTA
fitting assembly and loss of control of the airplane. For certain
airplanes, the initial HFEC inspection must be accomplished within 30
hours time-in-service or 60 calendar days after the effective date of
this AD, whichever occurs first. This compliance time is shorter than
the time necessary for the public to comment and for publication of the
final rule. Accordingly, notice and opportunity for prior public
comment are impracticable and contrary to the public interest pursuant
to 5 U.S.C. 553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forgo notice and
comment.

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 prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 103 airplanes of U.S.
registry. 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
----------------------------------------------------------------------------------------------------------------
Initially inspect HTTA fitting          55 work-hours x $85 per               $0          $4,675        $481,525
 assembly.                               hour = $4,675.
Report results........................  1 work-hour x $85 per                  0              85           8,755
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
corrective action that would be required based on the results of any
inspection. The agency has no way of determining the number of aircraft
that might need these actions:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                Action                        Labor cost          Parts cost            Cost per product
----------------------------------------------------------------------------------------------------------------
Repetitively inspect HTTA fitting      55 work-hours x $85 per               0  $4,675 per inspection cycle.
 assembly.                              hour = $4,675.
Report results.......................  1 work-hour x $85 per                 0  $85.
                                        hour = $85.
Repair light corrosion...............  1 work-hour x $85 per                 0  $85 per inspection cycle.
                                        hour = $85.
Replace HTTA fitting assembly........  13 work-hours x $85 per           4,750  $5,855.
                                        hour = $1,105.
----------------------------------------------------------------------------------------------------------------

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    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.

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2023-16-04 Piaggio Aviation S.p.A.: Amendment 39-22523; Docket No.
FAA-2023-1712; Project Identifier MCAI-2023-00821-A.

(a) Effective Date

    This airworthiness directive (AD) is effective August 30, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following Piaggio Aviation S.p.A. Model
P-180 airplanes, certificated in any category:
    (1) Serial numbers (S/N) 1002, 1034 through 1234 inclusive, 3001
through 3014 inclusive, 3016, and 3018; and
    (2) S/N 1004 through 1033 inclusive if modified in accordance
with Piaggio Service Bulletin 80-0142.

(d) Subject

    Joint Aircraft System Component (JASC) Code: 5520, Elevator
Structure.

(e) Unsafe Condition

    This AD was prompted by a report of corrosion-induced cracking
on the horizontal tail trim actuator (HTTA) fitting assembly. The
FAA is issuing this AD to address structural failure of the HTTA
fitting assembly. The unsafe condition, if not addressed, could
result in loss of control of the airplane.

(f) Compliance

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

(g) Definitions

    (1) For purposes of this AD, ``light corrosion'' is corrosion
that does not exceed a depth of 0.15 millimeter (mm) and does not
extend beyond 1 square inch (645.2 square mm).
    (2) For purposes of this AD, a ``new part'' is a part with zero
hours time-in-service (TIS).

(h) Inspection

    Within the compliance time for your airplane listed in Table 1
to paragraph (h) of this AD, do a high frequency eddy current
inspection of HTTA fitting assembly part number (P/N) 80-363283-401
for corrosion and cracking in accordance with Section 2.B., Part A,
Steps (11) through (14) of the Accomplishment Instructions in
Piaggio Aerospace Service Bulletin 80-0492, Revision 3, dated June
12, 2023.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TR15AU23.005

(i) Corrective Actions

    Based on the result of the inspection required by paragraph (h)
of this AD, do the applicable corrective action within the
applicable compliance time specified in Table 2 to paragraph (i) of
this AD.
[GRAPHIC] [TIFF OMITTED] TR15AU23.006

BILLING CODE 4910-13-C

(j) Terminating Action

    Replacing the HTTA fitting assembly with a new part in
accordance with Piaggio Aerospace Temporary Revision TR-031 to
Chapter 51-70-70, dated May 29, 2023, to the Piaggio P.180
Structural Repair Manual constitutes terminating action for the
repetitive inspections required by paragraph (i) of this AD for that
airplane.

(k) Credit for Previous Action

    You may take credit for the initial inspection required by
paragraph (h) of this AD if you performed the initial inspection
before the effective date of this AD using Piaggio Aerospace Service
Bulletin 80-0492, Revision 2, dated May 15, 2023.

(l) Reporting Requirement

    Report to the manufacturer the results of each inspection
required by paragraphs (h) and (i) of this AD within the applicable
compliance time specified in paragraph (l)(1) or (2) of this AD
using the Confirmation Slip

attached to Piaggio Aerospace Service Bulletin 80-0492, Revision 3,
dated June 12, 2023.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 10 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 10 days after the effective date of
this AD.

(m) Alternative Methods of Compliance (AMOCs)

    The Manager, International Validation 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 International Validation Branch, mail
it to the address identified in paragraph (n)(2) of this AD or email
to: [email protected]. If mailing information, also submit
information by email. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office.

(n) Additional Information

    (1) Refer to European Union Aviation Safety Agency (EASA) AD
2023-0122R1, dated July 5, 2023, for related information. This EASA
AD may be found in the AD docket at regulations.gov under Docket No.
FAA-2023-1712.
    (2) For more information about this AD, contact Mike Kiesov,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; email:
[email protected].
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(3) and (4) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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) Piaggio Aerospace Service Bulletin 80-0492, Revision 3,
dated June 12, 2023.
    (ii) Piaggio Aerospace Temporary Revision TR-031 to Chapter 51-
70-70, dated May 29, 2023, to the Piaggio P.180 Structural Repair
Manual.
    (3) For service information identified in this AD, contact
Piaggio Aero Industries S.p.A., P180 Customer Support, via Pionieri
e Aviatori d'Italia, snc-16154 Genoa, Italy; phone: +39 331 679 74
93; email: [email protected].
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 8, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-17575 Filed 8-11-23; 4:15 pm]
BILLING CODE 4910-13-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, D.C.  20460

                                   OFFICE OF PREVENTION, PESTICIDES

                                            AND TOXIC SUBSTANCES

MEMORANDUM

TO:		Chloropicrin Reregistration Eligibility Decision (RED) Team

FROM:	Nathan Mottl, Reregistration Branch 1

Special Review and Reregistration Division

SUBJECT:	Revised Use Closure Memorandum for Chloropicrin, Chemical No.
081501

DATE:	June 6, 2005

As a result of the December 7, 2000 Smart Meeting on chloropicrin uses
and the update meeting held on June 29, 2004, this memorandum will act
as the Agency’s record of common understanding on the uses of
chloropicrin to be included in the risk assessment. This memo revises
the original use closure memo written by Kelly White on March 9, 2005
after the Agency received use pattern comments from the Chloropicrin
Manufacturers Task Force (CMTF) on April 22, 2005.

Chloropicrin is used as an insecticide, nematicide, fungicide, and
herbicide.  Chloropicrin is phytotoxic, and is used to sterilize soil
prior to planting.  It is applied as a fumigant and can be applied
alone, with methyl bromide, or with Telone (e.g., 1,3-Dichloropropene).
Chloropicrin is registered for pre-plant soil fumigation of land to be
planted with a wide variety of food, ornamental, and nursery crops.
Chloropicrin uses are also being supported for the in-situ treatment of
wooden utility poles, piles and timber members.  The major use is for
utility poles; however, railroad structures are often treated with
chloropicrin as well.

There are no food uses of chloropicrin.  All post-harvest food storage
area uses have been cancelled and the associated tolerances are being
revoked.  Chloropicrin is registered for use as a warning agent in
methyl bromide formulations for treating empty grain storage bins, but
this use is a non-food use that does not require a tolerance.

The Chloropicrin Manufacturers Task Force (CMTF) is comprised of the
four companies that produce technical chloropicrin – Niklor Chemicals,
Inc., Arvesta Corporation, ASHTA Chemicals, Inc., and Trinity
Manufacturing, Inc.  Steptoe & Johnson L.L.P. represents the CMTF.
Other chloropicrin registrants include:  Tri-Cal Chemicals, Great Lakes
Chemical, Osmose Railroad Services, Inc., Osmose Utility Services, Inc.,
Albemarle Corporation, Soil Chemical Corporation, Ameribrom Inc.,
Hendrix and Dail Inc., Reddick Fumigants, Inc., Shadow Mountain Products
Corporation, Holtrachem, and Dow AgroSciences LLC.  There are 60
products total – 6 technical formulations and 54 end-use products.

USES

Chloropicrin is registered as a pre-plant soil fumigant for land to be
planted with the following crops:

Berries: Caneberries, blackberries, boysenberries, dewberries,
loganberries, raspberries, youngberries, blueberries, cranberries,
gooseberries, huckleberries.

Small fruits: Strawberries, currants, grapes, kumquat, bananas, figs,
persimmons, pineapple, pomegranates, tree fruits (all), vine fruits
(all).

Citrus fruits: Grapefruit, lemon, limes, oranges, tangelos, tangerines.

Nut crops: Almonds, cashews, chestnuts, filberts, hickory nuts, pecans,
walnuts, pistachios

Pome and stone fruits: Apples, pears, quinces, apricots, cherries,
nectarines, peaches, plums, prunes, dates.

Cucurbits: Melons (all), cantaloupes, casaba  melons, crenshaw melons,
honeydew, muskmelons, persian melons, watermelon, cucumbers, pumpkins,
squash (summer and winter), mango melons.

Vegetables: asparagus, eggplant, peppers, pimentos, tomatoes, cole
crops, broccoli, Brussels sprouts, cabage, cauliflower, collards, kale,
kohlrabi, endive, lettuce (all), mustard, spinach, Swiss chard, carots,
garlic, leeks, okra, onions, parsnips, potatoes, radishes, rutabagas,
salsify, shallots, sweet potato, yams, popcorn, garden beets, celery,
turnips, vegetables (all).

Field crops: beans (all), peas (all), kenaf, forage-fodder grasses
(all), pastures, alfalfa, clover, lespedeza, vetch, birdsfoot trefoil,
barley, corn, oats, rye, sorghum, wheat, sugarcane, buckwheat, tobacco,
safflower, cotton, flax, peanuts, soybeans, millet.

Ornamentals: golf course turf, ornamental turf, forest trees (all),
herbaceous plants (all), woody plants (all), flowering plants (all).

Miscellaneous: Hops, horseradish, mint, olives, greenhouse soils,
mushroom house soils.

Chloropicrin is used both as the sole active ingredient in chloropicrin
end-use formulations and as an active ingredient in end-use formulations
in which methyl bromide or Telone is also an active ingredient.  In
addition, chloropicrin is part of the end-use formulation for the
iodomethane soil fumigant, which is undergoing registration review.
Chloropicrin is also used as a warning agent with these soil fumigants
at levels of two percent or less by weight in the formulation.

cc:  Sara Beth Watson, Steptoe & Johnson L.L.P.

 PAGE  2


[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Notices]
[Pages 52183-52185]
[FR Doc No: 2023-16814]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1530]

Recommended Acceptable Intake Limits for Nitrosamine Drug
Substance-Related Impurities; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-
Related Impurities (NDSRIs).'' This guidance provides applicants and
manufacturers of drugs, including prescription and over-the-counter
(OTC) drug products, with a recommended framework for predicting the
mutagenic and carcinogenic potential of NDSRIs that could be present in
drug products and recommends acceptable intake (AI) limits for NDSRIs.
NDSRIs, which are a subcategory of nitrosamine impurities that share
structural similarity to the active pharmaceutical ingredient (API) in
drug products, typically lack compound-specific mutagenicity and
carcinogenicity data to inform safety assessments. This guidance
provides a recommended methodology for AI determination that uses
structural features of NDSRIs to generate a predicted carcinogenic
potency categorization and corresponding recommended AI limit that
manufacturers and applicants can apply, in the absence of other FDA-
recommended AI limits, in their evaluation of potential impurities in
their drug products.

DATES: The announcement of the guidance is published in the Federal
Register on August 7, 2023.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1530 for ``Recommended Acceptable Intake Limits for
Nitrosamine Drug Substance-Related Impurities (NDSRIs).'' 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,<PHONE_NUMBER>.
     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 the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Bldg., 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT: Jason Bunting, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-1292.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Recommended Acceptable Intake Limits for Nitrosamine Drug
Substance-Related Impurities (NDSRIs).'' FDA is implementing this
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (Sec.
10.115(g)(2)). FDA made this determination because of the importance of
providing additional timely information to manufacturers and applicants
regarding recommended AI limits of NDSRIs, a class of nitrosamine
impurities that has been identified in many drug products and also
could be present in APIs. This guidance applies to drugs, including
prescription and OTC drug products that are the subject of an approved
or pending new drug application (NDA) or abbreviated new drug
application (ANDA), as well as products \1\ not marketed under a drug
application, including nonprescription drugs subject to section 505G
(21 U.S.C. 355h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(i.e., OTC monograph drugs) or are otherwise subject to current good
manufacturing practice. This guidance also applies to prescription and
OTC drug products in clinical development. In addition, this guidance
applies to certain biological products that contain chemically
synthesized fragments or biologic-led combination products that contain
a drug constituent part whether such products are in development or the
subject of an approved or pending biologics license application (BLA).
The recommendations in this guidance apply to both drug product and
drug substance manufacturers.
---------------------------------------------------------------------------

    \1\ For the purposes of this guidance, we use the term ``drug''
or ``drug product'' to refer to human drug and biological products,
including drug-led and biologic-led combination products, regulated
by the Center for Drug Evaluation and Research, unless otherwise
specified.
---------------------------------------------------------------------------

    This guidance provides manufacturers and applicants of drugs with a
recommended framework for predicting the mutagenic and carcinogenic
potential of NDSRIs that could be present in drug products and
recommends AI limits for NDSRIs. This approach will assist
manufacturers and applicants in taking steps to detect and prevent
unacceptable levels of nitrosamine impurities in drug products.
Although this guidance document is immediately in effect, it remains
subject to comment in accordance with FDA's good guidance practices
regulation (Sec.  10.115(g)(3)(D)).
    Nitrosamine compounds have the potential to be potent genotoxic
agents in several animal species, and some are classified as probable
or possible human carcinogens. Nitrosamines are included in a group of
high potency mutagenic carcinogens referred to as ``cohort of concern''
compounds in the International Council for Harmonisation (ICH) guidance
for industry entitled ``M7(R1) Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals To Limit Potential
Carcinogenic Risk'' (March 2018). In 2020, FDA published a guidance for
industry, ``Control of Nitrosamine Impurities in Human Drugs,'' (85 FR
55017, September 3, 2020) (Nitrosamine Guidance), recommending that
manufacturers of APIs and drug products take steps to detect and
prevent unacceptable levels of nitrosamine impurities in drug products,
or avoid their presence when feasible, and updated the guidance on
February 24, 2021.
    NDSRIs are a class of nitrosamines sharing structural similarity to
the API, and thus, differ in certain respects from small molecule
nitrosamine impurities specified in the Nitrosamine Guidance. NDSRIs
are unique to each API and are generally formed in a drug product
through nitrosation of APIs (or API fragments) that have secondary or
tertiary amines when exposed to nitrosating agents such as residual
nitrites in excipients used to formulate the drug product. NDSRIs that
have been recently identified in a number of drug products generally
lack carcinogenicity and mutagenicity data (typically from animal
studies) from which an AI can be determined. Based on the chemical
structure of certain drugs, there is a risk of NDSRIs forming in a
substantial number of drug products; however, it is currently unknown
if all or some NDSRIs are in fact high-potency mutagenic carcinogens.
It is challenging to establish an AI limit for NDSRIs because of the
lack of available mutagenicity data and robust carcinogenicity data
from which applicants would otherwise determine AI limits. These
challenges have led to some applicants and manufacturers conducting
unnecessary studies or, in some cases, discontinuing drug products from
the market.
    FDA is recommending a predicted carcinogenic potency categorization
method that assigns a recommended AI limit to an NDSRI based on the
NDSRI's activating and deactivating structural features. Predicted
carcinogenic potency categories enable manufacturers to determine
recommended AI limits for NDSRIs in APIs and drug products and to
facilitate development of methods for confirmatory testing. Potency
categorization offers a scientifically based predictive solution to
recommending AI limits for data-poor NDSRIs, for which suitable
surrogates with robust carcinogenicity data are not available.
    The recommendations in this guidance provide a risk-based safety
assessment of NDSRIs and can be used by applicants and manufacturers to
identify AI limits for NDSRIs in their drug products and APIs in
conjunction with the recommendations in the Nitrosamine Guidance. If
FDA communicates another FDA-recommended AI limit for a specific NDSRI,
manufacturers and applicants should apply that recommended AI

limit rather than the AI limit recommended in this guidance based on
predicted carcinogenic potency. In general, FDA would expect
manufacturers and applicants to control impurities within the
recommended AI limit. Additionally, manufacturers and applicants should
continue to pursue mitigation efforts to reduce or remove NDSRIs in
their drug products.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Recommended Acceptable Intake Limits for
Nitrosamine Drug Substance-Related Impurities (NDSRIs).'' 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 guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR
parts 210 and 211 pertaining to current good manufacturing practice
have been approved under OMB control number 0910-0139. The collections
of information in 21 CFR part 312 pertaining to investigational new
drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 pertaining to
NDAs and ANDAs have been approved under OMB control number 0910-0001.
The collections of information in 21 CFR part 601 pertaining to BLAs
have been approved under OMB control number 0910-0338. The collections
of information in 21 CFR part 201 pertaining to OTC monograph drug
products have been approved under OMB control number 0910-0340.

III. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16814 Filed 8-4-23; 8:45 am]
BILLING CODE 4164-01-P


List of References Provided by One Panel

Route-to-Route Extrapolation

Pauluhn, J. (2003). Issues of dosimetry in inhalation toxicity. Tox.
Letters 140-141: 229-238. [refer to Section 3, pages 235-237 and Figures
4 and 5]. [abstract available from:
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TCR-487K2N9-G
&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchS
trId=1100730775&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVers
ion=0&_userid=10&md5=fd5d141b338e32473b953d6f876a99c0]

Duration Adjustments

Jarabek, A.M. (1995a). Consideration of Temporal Toxicity Challenges
Current Default Assumptions. Inhal. Toxicol. 7: 927-46. [abstract
available from:
http://www.informaworld.com/smpp/1962735530-65235248/content~db=all~cont
ent=a784797894]

Threshold of Toxicological Concern/Threshold of Regulation Approaches

Drew, R. and Frangos, J. (2007). The Concentration of No Toxicological
Concern (CoNTC): A Risk Assessment Screening Tool for Air Toxics. J.
Tox. Env. Health, Part A 70: 1584-1593. [This article provides an
excellent summary of the history of these types of approaches and shows
how these approaches have been used in a regulatory setting] [abstract
available from:
http://www.informaworld.com/smpp/content~content=a781628584~db=all~order
=page]

Time Extrapolation Factors

Kalberlah, F., Fost, U. and Schneider, K. (2002). Time Extrapolation and
Interspecies Extrapolation for Locally Acting Substances in Case of
Limited Toxicological Data. Ann. Occup. Hyg. 46: 175-185. [abstract
available from:  http://www.ncbi.nlm.nih.gov/pubmed/12074027]

Kramer, H.J., Ham, W.A. van den, Slob, W. And Pieters, M.N. (1996).
Conversion Factors Estimating Indicative Chronic
No-Observed-Adverse-Effect Levels from Short-Term Toxicity Data. Reg.
Tox. Pharm. 23: 249-255. [This paper is for oral exposure, but it
presents the mathematic approaches/equations needed to calculate the 95
percentile as well as the tolerance limits on the 95 percentile for a
log-normal distribution] [abstract available from:
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WPT-45N457K-3
F&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_search
StrId=1100728013&_rerunOrigin=google&_acct=C000050221&_version=1&_urlVer
sion=0&_userid=10&md5=043f838fd5fff026058adad8f59d3e58]

Kramer, H.J., Ham, W.A. van den, Slob, W. And Pieters, M.N. (1995).
Derivation of Conversion Factors to Estimate an Indicative Chronic NOAEL
from Short-Term Toxicity Data. RIVM Report 620110001. Bilthoven – the
Netherlands.   HYPERLINK
"http://www.rivm.nl/bibliotheek/rapporten/620110001.html"
http://www.rivm.nl/bibliotheek/rapporten/620110001.html

Pieters, M.N., Kramer, H.J., and Slob, W. (1997). The Applicability of
Conversion Factors for Indicative Standard Setting. RIVM report
620110003. Bilthoven – the Netherlands.   HYPERLINK
"http://www.rivm.nl/bibliotheek/rapporten/620110003.html"
http://www.rivm.nl/bibliotheek/rapporten/620110003.html


[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Rules and Regulations]
[Pages 10337-10340]
[FR Doc No: 2014-03033]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0670; Directorate Identifier 2013-NM-081-AD;
Amendment 39-17756; AD 2014-03-19]
RIN 2120-AA64

Airworthiness Directives; the Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 737-600, -700, -800, -900, and -900ER series
airplanes modified by particular supplemental type certificates (STCs).
This AD was prompted by reports of cracks found during inspections of
the in-flight entertainment system radome assembly. This AD requires
repetitive detailed inspections for cracks in the radome assembly, and
replacement of the radome if necessary. We are issuing this AD to
detect and correct cracks in the in-flight entertainment system radome
assembly, which could result in the radome (or pieces) separating from
the airplane and striking the tail, and consequently reducing the
controllability of the airplane.

DATES: This AD is effective April 1, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 1,
2014.

ADDRESSES: For service information identified in this AD, contact Live
TV, 8900 Hangar Boulevard, Orlando, FL 32827; phone:<PHONE_NUMBER>; fax:
407-812-2526; Internet http://www.livetv.net. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

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-2013-
0670; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Barry Culler, Aerospace Engineer,
Airframe Branch, ACE-117A, FAA, Atlanta Aircraft Certification Office
(ACO), 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-
5546; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain the Boeing Company
Model 737-600, -700, -800, -900, and -900ER series airplanes modified
by particular supplemental type certificates (STCs). The NPRM published
in the Federal Register on August 5, 2013 (78 FR 47233). The NPRM was
prompted by reports of cracks found during inspections of the in-flight
entertainment system radome assembly. The NPRM proposed to require
repetitive detailed inspections for cracks in the radome assembly, and
replacement of the radome if necessary. We are issuing this AD to
detect and correct cracks in the in-flight entertainment system radome
assembly, which could result in the radome (or pieces) separating from
the airplane and striking the tail, and consequently reducing the
controllability of the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
(78 FR 47233, August 5, 2013) and the FAA's response to each comment.
    Boeing stated that it does not have sufficient information
regarding the supplemental type certificates (STCs) referenced in the
NPRM (78 FR 47233, August 5, 2013); therefore, it has no comment.
    Aviation Partners Boeing stated that the installation of winglets
per STC ST00830SE (http://rgl.faa.gov/Regulatory;--and--Guidance--
Library/rgstc.nsf/0/
DA95C49000906C7086257BE80044D3D9?OpenDocument&Highlight=st00830se) does
not affect the accomplishment of the manufacturer's service
instructions.

Request To Remove Reporting Requirement

    United Air Lines (UAL) requested that the FAA and Live TV re-
evaluate the need for the reporting requirement proposed in paragraph
(h) of the NPRM (78 FR 47233, August 5, 2013), and remove this proposed
requirement. UAL questioned why operators would be required to fill out
the service bulletin reporting form provided in Live TV Service
Bulletin B737-53-0011, dated March 29, 2013, mentioned in paragraph (h)
of the NPRM, and send it to Live TV every time cracking is found on a
radome. UAL stated that any radome with cracking would be sent back to
the manufacturer with an unserviceable tag attached and that the
information on the tag would be the same information requested on the
service bulletin reporting form. UAL also noted that the information
requested on the reporting form is redundant because the reporting form
states that when cracking is found on a radome, the technician has to
record his or her name, service work order, and location of
accomplishment.
    We do not agree to remove the reporting requirement from this final
rule. For this AD, Live TV is the STC design approval holder (DAH) and
is gathering information reported by operators and reporting this
information to the FAA. There is no regulatory requirement for an
operator to return a part to a manufacturer. Regarding this final rule,
we agree that an operator may voluntarily provide a cracked radome to
Live TV, the STC DAH; however, if a reporting requirement was not
mandated by this AD, an operator might elect to repair a cracked radome
itself, or send it to another facility for repair, instead of sending
it to Live TV, so the information requested in the reporting
requirement might not be shared with Live TV. We have not changed this
final rule in this regard.

Request for Reporting Guidance

    UAL noted that the NPRM (78 FR 47233, August 5, 2013) proposed to
require operators to record and report the serial number of any cracked
radome. UAL stated that numerous times it has discovered that the
radome data plate, which has the serial number specified on it, is
missing. UAL commented that it can be difficult to use an operator's
record keeping system to determine the serial number of a radome
because the radome could have been rotated among airplanes. UAL
requested guidance regarding what to do if the data plate is missing
from a radome.
    We agree that the serial number is an important piece of
information for the reporting requirement of this final rule. However,
this final rule does not require an operator to identify the radome's
serial number prior to inspection. The reporting requirement is only
required if cracking is found in the radome during the inspection. If
cracking is found during the inspection an operator has 30 days to
provide the report. This timeframe should be sufficient for operators
to identify the radome's serial number by looking at the data plate or
the searching the operator's tracking system. The reporting requirement
is meant to help Live TV and the FAA trace back to the fabrication
records for potential causes of cracking in the radome.
    Based on review and consideration during Weibull Analysis, we
believe that rotating radomes among airplanes is not a common
occurrence. It is ultimately the operator's responsibility to maintain
its airplane configurations and subsequently provide the required
serial number information. We have not changed this final rule in this
regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     [Agr]re consistent with the intent that was proposed in
the NPRM (78 FR 47233, August 5, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 47233, August 5, 2013).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 165 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                    Labor cost        Parts cost      Cost per product         operators
----------------------------------------------------------------------------------------------------------------
Inspections.....................  1 work-hour x $85               N/A  $85, per inspection  $14,025, per
                                   per hour = $85,                      cycle.               inspection cycle
                                   per inspection
                                   cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspections. We have
no way of determining the number of aircraft that might need this
replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement..................................  8 work-hours x $85 per hour =           $23,000          $23,680
                                                $680.
----------------------------------------------------------------------------------------------------------------

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2014-03-19 the Boeing Company: Amendment 39-17756; Docket No. FAA-
2013-0670; Directorate Identifier 2013-NM-081-AD.

(a) Effective Date

    This AD is effective April 1, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Boeing Company Model 737-600, -700, -800,
-900, and -900ER series airplanes, certificated in any category,
with Live TV radomes having part number 5063-100-V3 or 5063-101-V2
and a serial number in the range of 001 through 497 inclusive, and
modified by the applicable supplemental type certificate (STC)
identified in paragraphs (c)(1) and (c)(2) of this AD.
    (1) ST00284BO (http://rgl.faa.gov/Regulatory--and--Guidance--
Library/rgstc.nsf/0/3ecc2e5e5f408bc1862579b30048ed60/$FILE/
ST00284BO.pdf).
    (2) ST02887AT (http://rgl.faa.gov/Regulatory--and--Guidance--
Library/rgstc.nsf/0/9bf85b85ea3e295d8625735600721055/$FILE/
ST02887AT.pdf).

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of cracks found during
inspections of the radome assembly. We are issuing this AD to detect
and correct cracks in the in-flight entertainment system radome
assembly, which could result in the radome (or pieces) separating
from the airplane and striking the tail, and consequently reducing
the controllability of the airplane.

(f) Compliance

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

(g) Repetitive Inspections and Corrective Actions

    Within 1,250 flight hours after the effective date of this AD:
Perform a detailed inspection for cracks of the radome assembly, in
accordance with the Accomplishment Instructions of Live TV Service
Bulletin B737-53-0011, dated March 29, 2013. Repeat the inspection
thereafter at intervals not to exceed 1,250 flight hours. If any
crack is found during any inspection required by this paragraph,
before further flight, replace the radome, in accordance with the
Accomplishment Instructions of Live TV Service Bulletin B737-53-
0011, dated March 29, 2013.

(h) Reporting Requirement

    If any crack is found during any inspection required by
paragraph (g) of this AD, submit a report of the findings to Live
TV, 8900 Hangar Boulevard, Orlando, FL 32827; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>at the applicable
time specified in paragraph (h)(1) or (h)(2) of this AD. The report
must include the information specified in the service bulletin
reporting form provided in Live TV Service Bulletin B737-53-0011,
dated March 29, 2013.
    (1) If the inspection was accomplished on or after the effective
date of this AD: Submit the report within 30 days after the
inspection.
    (2) If the inspection was accomplished before the effective date
of this AD: Submit the report within 30 days after the effective
date of this AD.

(i) Special Flight Permit

    Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

(j) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (l) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) If the service information contains steps that are labeled
as RC (Required for Compliance), those steps must be done to comply
with this AD; any steps that are not labeled as RC are recommended.
Those steps that are not labeled as RC may be deviated from, done as
part of other actions, or done using accepted methods different from
those identified in the specified service information without
obtaining approval of an AMOC, provided the steps labeled as RC can
be done and the airplane can be put back in a serviceable condition.
Any substitutions or changes to steps labeled as RC require approval
of an AMOC.

(l) Related Information

    For more information about this AD, contact Barry Culler,
Aerospace Engineer, Airframe Branch, ACE-117A, FAA, Atlanta Aircraft
Certification Office (ACO), 1701 Columbia Avenue, College Park, GA
30337; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(m) 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) Live TV Service Bulletin B737-53-0011, dated March 29, 2013.
    (ii) Reserved.
    (3) For service information identified in this AD, contact Live
TV, 8900 Hangar Boulevard, Orlando, FL 32827; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; Internet http://www.livetv.net.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on February 5, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-03033 Filed 2-24-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Pages 49300-49301]
[FR Doc No: 2014-19656]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG14-83-000.
    Applicants: Regulus Solar, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Regulus Solar, LLC.
    Filed Date: 8/11/14.
    Accession Number: 20140811-5179.
    Comments Due: 5 p.m. ET 9/2/14.

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

    Docket Numbers: ER14-1242-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-08-11--SA 6506--Presque Isle SSR Compliance
Filing to be effective 2/1/2014.
    Filed Date: 8/11/14.
    Accession Number: 20140811-5169.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-1243-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-08-11--Presque Isle SSR Related Compliance Filing
to be effective 4/3/2014.
    Filed Date: 8/11/14.
    Accession Number: 20140811-5167.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-1243-004.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-08-11--Presque Isle Schedule 43G Compliance
Filing to be effective 4/3/2014.
    Filed Date: 8/11/14.
    Accession Number: 20140811-5185.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2627-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: 2014-08-11--SA 2685 Ameren-SIPC Wholesale Umbrella
Construction Agreement to be effective 7/10/2014.
    Filed Date: 8/11/14.
    Accession Number: 20140811-5147.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2628-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: 2014-08-11--SA 2686 Ameren-SIPC Wholesale Connection
Agreement to be effective 7/10/2014.
    Filed Date: 8/11/14.
    Accession Number: 20140811-5148.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2629-000.
    Applicants: California Independent System Operator Corporation.
    Description: 2014-08-11--SycamorePenasquitos APSA to be effective
10/11/2014.
    Filed Date: 8/11/14.
    Accession Number: 20140811-5159.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2630-000.
    Applicants: Regulus Solar, LLC.
    Description: Market Based Rate Schedule to be effective 8/12/2014.
    Filed Date: 8/11/14.
    Accession Number: 20140811-5166.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2631-000.
    Applicants: Atlantic City Electric Company.
    Description: Market-Based Rate Tariff Revisions to be effective 8/
12/2014.

    Filed Date: 8/12/14.
    Accession Number: 20140812-5001.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2632-000.
    Applicants: Delmarva Power & Light Company.
    Description: Market-Based Rate Tariff Revisions to be effective 8/
12/2014.
    Filed Date: 8/12/14.
    Accession Number: 20140812-5002.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2633-000.
    Applicants: Potomac Electric Power Company.
    Description: Market-Based Rate Tariff Revisions to be effective 8/
12/2014.
    Filed Date: 8/12/14.
    Accession Number: 20140812-5003.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2634-000.
    Applicants: Potomac Power Resources, LLC.
    Description: Market-Based Rate Tariff Revisions and Notice of
Succession to be effective 8/12/2014.
    Filed Date: 8/12/14.
    Accession Number: 20140812-5004.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2635-000.
    Applicants: Bethlehem Renewable Energy, LLC.
    Description: Market-Based Rate Tariff Revisions to be effective 8/
12/2014.
    Filed Date: 8/12/14.
    Accession Number: 20140812-5005.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2636-000.
    Applicants: Fauquier Landfill Gas, LLC.
    Description: Market-Based Rate Tariff Revisions to be effective 8/
12/2014.
    Filed Date: 8/12/14.
    Accession Number: 20140812-5006.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2637-000.
    Applicants: Eastern Landfill Gas, LLC.
    Description: Market-Based Rate Tariff Revisions to be effective 8/
12/2014.
    Filed Date: 8/12/14.
    Accession Number: 20140812-5007.
    Comments Due: 5 p.m. ET 9/2/14.

    Docket Numbers: ER14-2638-000.
    Applicants: Pepco Energy Services, Inc.
    Description: Market-Based Rate Tariff Revisions to be effective 8/
12/2014.
    Filed Date: 8/12/14.
    Accession Number: 20140812-5041.
    Comments Due: 5 p.m. ET 9/2/14.

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

    Dated: August 12, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-19656 Filed 8-19-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Rules and Regulations]
[Page 1709-1712]
[DOCID:fr13ja10-10]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-1057]
RIN 1625-AA87

Security Zone; Escorted U.S. Navy Submarines in Sector Seattle
Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Interim rule with request for comments.

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

SUMMARY: The Coast Guard is establishing a moving security zone around
any U.S. Navy submarine that is operating in the Sector Seattle Captain
of the Port Zone, which includes the Puget Sound and coastal waters of
the State of Washington, and is being escorted by the Coast Guard. The
security zone is necessary to help ensure the security of the
submarines, their Coast Guard security escorts, and the maritime public
in general. The security zone will do so by prohibiting all persons and
vessels from coming within 1,000 yards of an escorted submarine unless
authorized by the Coast Guard patrol commander.

DATES: This rule is effective January 13, 2010. Comments and related
material must reach the Coast Guard on or before April 13, 2010.
Requests for public meetings must be received by the Coast Guard on or
before February 12, 2010.

ADDRESSES: You may submit comments identified by docket number USCG-
2009-1057 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 interim
rule, call or e-mail LT Matthew N. Jones, Staff Attorney, Thirteenth
Coast Guard District; telephone<PHONE_NUMBER>, e-mail
<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:

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-2009-1057), 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 http://

www.regulations.gov, it will be considered received by the Coast Guard
when you successfully transmit the comment. If you fax, hand deliver,
or mail your comment, it will be considered as having been received by
the Coast Guard when it is received at the Docket Management Facility.
We recommend that you include your name and a mailing address, an e-
mail 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-2009-1057'' in the ``Keyword'' box.
Click ``Search,'' then click on the balloon shape in the ``Actions''
column. If you submit 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 this 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-2009-1057'' 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 February 12, 2010 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.

Regulatory Information

    The Coast Guard is issuing this interim rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because publishing an NPRM would be contrary
to the public interest since U.S. Navy submarine operations in the
Sector Seattle Captain of the Port Zone are ongoing, making the
security zone created by this rule immediately necessary to help ensure
the security of the submarines, their Coast Guard security escorts, and
the maritime public in general.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register because waiting 30 days would be
contrary to the public interest since U.S. Navy submarine operations in
the Sector Seattle Captain of the Port Zone are ongoing, making the
security zone created by this rule immediately necessary to help ensure
the security of the submarines, their Coast Guard security escorts, and
the maritime public in general.

Background and Purpose

    U.S. Navy submarines frequently operate in the Sector Seattle
Captain of the Port Zone as defined in 33 CFR 3.65-10, which includes
the Puget Sound and coastal waters of the State of Washington. Due to
the numerous security concerns involved with submarine operations near
shore, the Coast Guard frequently provides security escorts of
submarines when operating in those areas. Security escorts of this type
require the Coast Guard personnel on-scene to make quick judgments
about the intent of vessels operating in close proximity to the
submarines and decide, occasionally with little information about the
vessels or persons on board, whether or not they pose a threat to the
submarine.
    The security zone established by this rule will keep persons and
vessels a sufficient distance away from submarines operating in and
around the Puget Sound and coastal waters of Washington so as to (1)
avoid unnecessary and potentially dangerous contact with or distraction
of Coast Guard security escorts and (2) give Coast Guard security
escorts additional time and space to determine the intent of vessels
that, for whatever reason, are operating too close to a submarine. Both
of these effects will help ensure the security of the submarines, their
Coast Guard security escorts, and the maritime public in general.

Discussion of Rule

    This rule establishes a moving security zone encompassing all
waters within 1,000 yards of any U.S. Navy submarine that is operating
in the Sector Seattle Captain of the Port Zone as defined in 33 CFR
3.65-10, which includes the Puget Sound and coastal waters of the State
of Washington, and is being escorted by the Coast Guard. All persons
and vessels are prohibited from entering the security zone unless
authorized by the Coast Guard patrol commander. While naval vessel
protection zones, under 33 CFR 165.2030, around these escorted U.S.
Navy submarines are still in effect, persons would need to seek
permission from the Coast Guard patrol commander to enter within 1,000
yards of these escorted submarines while they are in the Sector Seattle
Captain of the Port Zone.

Regulatory Analyses

    We developed this interim 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, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    The Coast Guard has made this determination based on the fact that
(1) the security zone is only in effect for the

short periods of time when submarines are operating in and around the
Puget Sound and other coastal waters of Washington and being escorted
by the Coast Guard, (2) the security zone moves with the submarines,
(3) vessels will be able to transit around the security zone at most
locations in the Puget Sound and other coastal waters of Washington,
and (4) vessels may, if necessary, be authorized to enter the security
zone with the permission of the Coast Guard patrol commander.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this 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 rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
transit an area covered by the security zone. The security zone will
not, however, have a significant economic impact on a substantial
number of small entities because (1) the security zone is only in
effect for the short periods of time when submarines are operating in
and around the Puget Sound and other coastal waters of Washington and
being escorted by the Coast Guard, (2) the security zone moves with the
submarines, (3) vessels will be able to transit around the security
zone at most locations in the Puget Sound and other coastal waters of
Washington, and (4) vessels may, if necessary, be authorized to enter
the security zone with the permission of the Coast Guard patrol
commander.
    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 offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls 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 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 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect 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 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 rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this 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 concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves the establishment of a
security zone. An environmental analysis checklist and a categorical
exclusion determination are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 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.

0
2. Add Sec.  165.1327 to read as follows:

Sec.  165.1327  Security Zone; Escorted U.S. Navy Submarines in Sector
Seattle Captain of the Port Zone.

    (a) Location. The following area is a security zone: All waters
within 1,000 yards of any U.S. Navy submarine that is operating in the
Sector Seattle Captain of the Port Zone, as defined in 33 CFR 3.65-10,
and that is being escorted by the Coast Guard.
    (b) Regulations. In accordance with the general regulations in 33
CFR part 165, subpart D, no person or vessel may enter or remain in the
security zone created by paragraph (a) of this section unless
authorized by the Coast Guard patrol commander. 33 CFR part 165,
subpart D, contains additional provisions applicable to the security
zone created in paragraph (a) of this section.
    (c) Notification. The Coast Guard security escort will attempt,
when necessary and practicable, to notify any persons or vessels inside
or in the vicinity of the security zone created in paragraph (a) of
this section of its existence via VHF Channel 16 and/or any other means
reasonably available.

    Dated: December 16, 2009.
G.T. Blore,
Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard
District.
[FR Doc. 2010-438 Filed 1-12-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: November 16, 2006 (Volume 71, Number 221)]
[Notices]
[Page 66777-66778]
[DOCID:fr16no06-70]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of FERC Staff Attendence at Entergy Independent
Coordinator of Transmission (Southwest Power Pool) Near-Term
Transmission Issues Group Meeting, Long-Term Transmission Issues
Working Group Meeting, and Stakeholders Policy Committee Meeting

November 9, 2006.
    The Federal Energy Regulatory Commission hereby gives notice that
members of its staff may attend the meetings noted below. Their
attendance is part of the Commission's ongoing outreach efforts.

ICT Near-Term Transmission Issues Group
    November 13, 2006 (1 p.m.-5 p.m. CST), Double Tree Hotel-Houston
Intercontinental Airport, 15747 John F. Kennedy Blvd., Houston, Texas
77032,<PHONE_NUMBER>.

ICT Long-Term Transmission Issues Working Group
    November 14, 2006 (8 a.m.-12 p.m. CST), Double Tree Hotel-Houston
Intercontinental Airport, 15747 John F. Kennedy Blvd., Houston, Texas
77032,<PHONE_NUMBER>.

ICT Stakeholders Policy Committee Meeting
    November 14, 2006 (1 p.m.-5 p.m. CST), Double Tree Hotel-Houston
Intercontinental Airport, 15747 John F. Kennedy Blvd., Houston, Texas
77032,<PHONE_NUMBER>.

    The discussions may address matters at issue in the following
proceedings:

Docket No. EL01-88.....................  Entergy Services, Inc.
Docket No. ER05-1065...................  Entergy Services, Inc.
Docket No. ER03-171....................  Entergy Mississippi, Inc.
Docket No. EL02-107....................  Duke Energy Hinds, LLC,
                                         Duke Energy Hot Spring, LLC,
                                         Duke Energy Southaven, LLC,
                                         Duke Energy North America, LLC.
                                          v.
                                         Entergy Services, Inc.,
                                         Entergy Operating Companies.
Docket No. ER02-405....................  Entergy Services, Inc.
Docket No. EL02-88.....................  Wrightsville Power Facility, L.L.C.
                                          v.
                                         Entergy Arkansas, Inc.
Docket Nos. EL03-3, ER02-1472..........  Entergy Gulf States, Inc.
Docket Nos. EL03-4, ER02-1151..........  Entergy Services, Inc.
Docket No. EL03-5, ER02-1609...........  Entergy Services, Inc.
Docket No. EL03-3......................  Entergy Operating Companies.
Docket No. ER02-1472...................  Entergy Operating Companies.
Docket No. EL03-4......................  Entergy Operating Companies.

Docket No. ER02-1069...................  Entergy Operating Companies.
Docket No. EL03-13.....................  Entergy Operating Companies.
Docket No. ER02-2243...................  Entergy Operating Companies.
Docket No. EL05-15.....................  Arkansas Electric Cooperative Corporation
                                          v.
                                         Entergy Arkansas, Inc.
Docket No. EL06-76.....................  Arkansas Public Service Commission
                                          v.
                                         Entergy Services, Inc., et al.
Docket No. ER03-583....................  Entergy Services, Inc. and EWO Marketing, L.P.
Docket No. ER03-681, ER03-682..........  Entergy Services, Inc. and Entergy Power, Inc.
Docket No. ER03-744....................  Entergy Services, Inc. and Entergy Louisiana, Inc.
Docket No. TX06-1......................  Louisiana Energy and Power Authority.
Docket No. EL04-20.....................  Carville Energy LLC
                                          v.
                                         Entergy Services, Inc.
Docket No. EL04-49.....................  Quachita Power LLC
                                          v.
                                         Entergy Services, Inc.
Docket No. EL04-99.....................  Mississippi Delta Entergy Agency, et al.
                                          v.
                                         Entergy Services, Inc.
Docket No. EL05-1......................  Union Power Partners
                                          v.
                                         Entergy Services, Inc.
Docket No. EL05-21.....................  Tenaska Frontier Partners
                                          v.
                                         Entergy Services, Inc.
Docket No. ER06-1555-000...............  Entergy Services, Inc.
Docket No. ER03-1272, EL05-22..........  Entergy Services, Inc.

    These meetings are open to the public.
    For more information, contact Tony Ingram, Office of Energy Markets
and Reliability, Federal Energy Regulatory Commission at<PHONE_NUMBER>
or<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
 [FR Doc. E6-19355 Filed 11-15-06; 8:45 am]

BILLING CODE 6717-01-P