[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Notices]
[Pages 57793-57795]
[FR Doc No: 2011-23771]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65314; File No. SR-NYSEAmex-2011-69]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Its
Options Fee Schedule To Add Clarifying Language With Respect to
Marketing Charges Generally and Marketing Charges for Directed Orders,
and To Add New and Clarifying Language With Respect to Marketing
Charges for Electronic Complex Orders

September 12, 2011.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on September 6, 2011, NYSE Amex LLC (the ``Exchange'' or
``NYSE Amex'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Options Fee Schedule (the
``Schedule'') to add clarifying language with respect to marketing
charges generally and marketing charges for Directed Orders, and to add
new and clarifying language with respect to marketing charges for
Electronic Complex Orders. The text of the proposed rule change is
available at the Exchange, the Commission's Public Reference Room, on
the Commission's Web site at http://www.sec.gov, and http://www.nyse.com.

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

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

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

1. Purpose
    The current Schedule in footnote 11 describes the distribution of
the pool of monies for marketing charges for non-Directed Orders, but
does not include any language addressing the marketing charges for
Directed Orders or Electronic Complex Orders. Currently, the pool of
monies resulting from collection of marketing charges on electronic
Directed Orders is controlled by the NYSE Amex Options Market Maker to
which the order was directed.\4\ In addition, Electronic Complex Orders
are treated in the same manner as non-Directed Orders, and
consequently, the pool of monies resulting from collection of marketing
charges on such orders is controlled by a Specialist or e-
Specialist.\5\
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    \4\ See, e.g., Securities Exchange Act Release No. 61849 (April
6, 2010), 75 FR 18556 (April 12, 2010) (SR-NYSEAmex-2010-30).
    \5\ The Exchange recently reinstituted the standard marketing
charges for Electronic Complex Order executions that had been
temporarily waived in July 2010. See Securities Exchange Act Release
No. 64524 (May 19, 2011), 76 FR 30412 (May 25, 2011) (SR-NYSEAmex-
2011-30). The Exchange had been informed by several Order Flow
Providers that the absence of marketing charges for Customer
executions in the complex order book was hindering their ability to
route complex order flow to the Exchange, particularly since
competing exchanges do allow for the collection of marketing charges
on complex orders. Consequently, the Exchange recently resumed its
prior practice of treating Electronic Complex Orders in the same
manner as any other orders for the purpose of assessing payment for
order flow charges in order to remain competitive.

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    After reviewing the current Schedule and the manner in which
marketing charges are handled for Electronic Complex Orders, the
Exchange has determined to add clarifying language to the Schedule with
respect to marketing charges generally and marketing charges for
Directed Orders, and to add new and clarifying language to it with
respect to marketing charges for Electronic Complex Orders.\6\ The
changes to the Schedule are described below.
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    \6\ NYSE Amex is not proposing to change the amount of the
marketing charges as part of this rule change.
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    First, the Exchange proposes to amend footnote 11 of its Schedule
to add a clarifying introductory statement that the footnote applies
only to marketing charges.
    Second, the current text in footnote 11 relating to the collection
and distribution of marketing charges for non-Directed Orders would
remain unchanged. That text provides that the pool of monies resulting
from the collection of marketing charges on electronic non-Directed
Order flow is controlled by the Specialist or the e-Specialist with
superior volume performance over the previous quarter for distribution
by the Exchange at the direction of such Specialist or e-Specialist to
eligible payment accepting firms. In making this determination the
Exchange, on a class by class basis, evaluates Specialist and e-
Specialist performance based on the number of electronic contracts
executed at NYSE Amex per class. The Specialist/ e-Specialist with the
best volume performance controls the pool of marketing charges
collected on electronic non-Directed Order flow for these issues for
the following quarter.
    Third, the Exchange proposes to add text thereafter stating its
existing policy that the pool of monies resulting from collection of
marketing charges on electronic Directed Order flow will be controlled
by the NYSE Amex Options Market Maker to which the order was directed,
and distributed by the Exchange at the direction of such NYSE Amex
Options Market Maker to payment accepting firms.
    Fourth, the Exchange proposes to add new text to footnote 11
stating that an ATP Holder that submits an Electronic Complex Order to
the Exchange may designate an NYSE Amex Options Market Maker to receive
the marketing charge and the pool of monies resulting from the
collection of such marketing charges will be distributed by the
Exchange at the direction of such NYSE Amex Options Market Maker to
payment accepting firms. If an ATP Holder submits an Electronic Complex
Order to the Exchange without designating an NYSE Amex Options Market
Maker, the pool of monies resulting from the collection of such
marketing charges will be distributed in the same manner as non-
Directed Order flow, as is currently the practice (and as described
above).
    Finally, the Exchange proposes technical changes to footnote 11 to
correct references to defined terms.
    The Exchange is not proposing any change to NYSE Amex Options Rule
900.3NY(s), which sets forth the definition of Directed Order, NYSE
Amex Options Rule 964.1NY, which discusses the conditions NYSE Amex
Options Specialists and Market Makers must meet to receive Directed
Orders, or NYSE Amex Options Rule 980NY, which governs Electronic
Complex Order trading and provides that the Specialist Pool and
Directed Order Market Maker guaranteed participation afforded in NYSE
Amex Options Rule 964NY does not apply to executions against an
Electronic Complex Order. The proposed change would only affect the
distribution of the pool of monies resulting from marketing charges for
Electronic Complex Orders.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Securities Exchange Act of 1934
(the ``Act''),\7\ in general, and Section 6(b)(4) of the Act,\8\ in
particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among its
members and other persons using its facilities. The Exchange believes
that the clarifying changes to the Schedule described above will
provide more transparency to the marketing charge practices on the
Exchange. The Exchange also believes that providing ATP Holders with
the option to submit Electronic Complex Orders to the Exchange and
designate an NYSE Amex Options Market Maker to direct the resulting
marketing charges will help to attract additional Electronic Complex
Orders to the Exchange, which will benefit all market participants. The
Exchange operates in a highly competitive market comprised of nine U.S.
options exchanges in which sophisticated and knowledgeable market
participants can readily send order flow to competing exchanges if they
deem fee levels at a particular exchange to be excessive or
discriminatory.
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    \7\ 15 U.S.C. 78f(b). [sic]
    \8\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \9\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \10\ thereunder, because it establishes a due, fee, or other charge
imposed by the NYSE Amex.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2011-69 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAmex-2011-69. This

file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEAmex-2011-69 and should be submitted on or before
October 7, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-23771 Filed 9-15-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 26, 2009 (Volume 74, Number 57)]
[Notices]
[Page 13214-13215]
[DOCID:fr26mr09-78]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Joint Meeting of the Pediatric Advisory Committee and the
Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pediatric Advisory Committee and Oncologic Drugs
Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on Monday, April 27, 2009,
from 8 a.m. to 6 p.m.
    Addresses: Washington DC North/Gaithersburg Hilton, 620 Perry
Pkwy., Gaithersburg, MD 20877.
    Contact Person: Carlos Pe[ntilde]a, Office of the Commissioner (HF-
33), Food and Drug Administration, 5600 Fishers Lane (for express
delivery, rm. 14B-08), Rockville, MD 20857,<PHONE_NUMBER>, or by e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
8732310001. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: On Monday, April 27, 2009, the Pediatric Advisory Committee
and the Oncologic Drugs Advisory Committee will meet to discuss the
scientific and ethical issues involved in obtaining and using brain
biopsy specimens to evaluate gene expression patterns in children with
diffuse pontine gliomas.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 13, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief

statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before April 3, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by April 6,
2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Dr. Carlos
Pe[ntilde]a at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 19, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-6796 Filed 3-25-09; 8:45 am]

BILLING CODE 4160-01-S


XXIII  SEQ CHAPTER \h \r 1 . Paperwork Reduction Act of 1995

	This final rule contains information collection requirements that are
subject to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).  The title,
description, and respondent description of the information collection
requirements are given below, with estimates of the one-time burden of
establishing written procedures and the annual recordkeeping burden.
Included in the burden estimates are the time for reviewing
instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing each collection of
information.

Title: Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements

Description: Section 402(g) of the act gives us explicit authority to
issue a rule establishing current good manufacturing practice
requirements for dietary supplements. Section 402(g)(1) of the act
states that a dietary supplement is adulterated if “it has been
prepared, packed, or held under conditions that do not meet current good
manufacturing practice regulations.”  Section 402(g)(2) of the act
authorizes us to, by regulation, “prescribe good manufacturing
practices for dietary supplements.”  Under section 701(a) of the act
(21 U.S.C. 371), FDA may issue regulations necessary for the efficient
enforcement of the act.  Other relevant legal authority is discussed in
section V of this document.

We did not receive any direct comments on the Paperwork Reduction Act
analysis of the 2003 CGMP Proposal.  Many comments on the estimated
costs of the 2003 CGMP Proposal stated that we underestimated the annual
number of batches of dietary supplements produced.  Due to a
contractor’s error, we did underestimate the number of batches
produced.  This final paperwork reduction analysis corrects for this
error.  The final analysis also has been revised from the analysis of
the 2003 CGMP Proposal in order to incorporate the effects of revisions
to the proposed regulation, including reorganization.

Records are an indispensable component of CGMP.  The records required by
this final rule provide the foundation for the planning, control, and
improvement processes that constitute a quality control system.
Implementation of these processes in a manufacturing operation serves as
the backbone to CGMP.  The records will show what is to be manufactured;
what was, in fact, manufactured; and whether the controls that the
manufacturer put in place to control the identity, purity, strength, and
composition and limits on contaminants and to prevent adulteration were
effective.  Further, records will show whether and what deviations from
control processes occurred, facilitate evaluation and corrective action
concerning these deviations (including, where necessary, whether
associated batches of product should be recalled from the marketplace),
and enable a manufacturer to assure that the corrective action was
effective.  Further, records will show whether and what deviations from
control processes occurred, facilitate evaluation and corrective action
concerning these deviations (including, where necessary, whether
associated batches of product should be recalled from the marketplace),
and enable a manufacturer to assure that the corrective action was
effective. Written procedures and recordkeeping are necessary to provide
the type of documentation that will demonstrate that dietary supplements
are manufactured, packaged, labeled, and held in a manner that will
ensure the quality of the dietary supplements and that the dietary
supplement is packaged and labeled as specified in the master
manufacturing record.  Under section 701(a) of the act, we may issue
regulations necessary for the efficient enforcement of the act.  For
example, if you did not keep records documenting practices performed
during previous production runs, it would be difficult, if not
impossible, for us to determine whether, as stated under section
402(g)(1) of the act, the dietary supplement had been manufactured,
packaged, labeled, and held under conditions that meet these CGMP
requirements.  In addition, bBy requiring records, we will be able to
ensure that you follow CGMPS so that you ensure the quality of your
dietary supplements during manufacturing, packaging, labeling, or
holding operations.  The final rule establishes the minimum
manufacturing practices necessary to ensure that dietary supplements are
manufactured, packaged, labeled, or held in a manner that will ensure
the quality of the dietary supplements during manufacturing, packaging,
labeling or holding operations.

The records requirements of this final rule include written procedures
and records pertaining to: (1) Personnel; (2) sanitation; (3)
calibration of instruments and controls; (4) calibration, inspection, or
checks of automated, mechanical, or electronic equipment; (5)
maintaining, cleaning, and sanitizing equipment and utensils and other
contact surfaces; (6) water used that may become a component of the
dietary supplement; (7) production and process controls; (8) quality
control; (9) components, packaging, labels and product received for
packaging and labeling; (10) master manufacturing and batch production;
(11) laboratory operations; (12) manufacturing operations; (13)
packaging and labeling operations; (14) holding and distributing
operations; (15) returned dietary supplements; and (16) product
complaints.

Description of Respondents: Manufacturers, dietary supplement
manufacturers, packagers and re-packagers, labelers and re-labelers,
holders, distributors, warehousers, exporters, importers, large
businesses, and small businesses.

The recordkeeping requirements of the final rule are set forth in each
subpart.  In table 18 we list the one-time burdens associated with
establishing written procedures.  In table 19 we list the annual burdens
associated with recordkeeping.  In each table, where the same records
are mentioned in more than one provision of a subpart, we list the
burden under the provisions corresponding to the heading, “Under this
subpart, what records must you make and keep?” For some provisions
listed in table 19, we did not estimate the annual frequency of
recordkeeping because recordkeeping occasions consist of frequent brief
entries of dates, temperatures, monitoring results, or documentation
that specific actions were taken.  Information might be recorded a few
times a day, week, or month.  When the records burden involves frequent
brief entries, we entered one as the default for the annual frequency of
recordkeeping.  For example, many of the records listed under final §
111.35 in table 19, such as final § 111.35(b)(2) (documentation, in
individual equipment logs, of the date of the use, maintenance,
cleaning, and sanitizing of equipment), involve many short sporadic
entries over the course of the year, varying across equipment and plants
in the industry.  We did not attempt to estimate the actual number of
recordkeeping occasions for these provisions, but instead entered an
estimate of the average number of hours per year.  We entered the
default value of 1 as the annual frequency of recordkeeping for these
and similar provisions.  For final § 111.35, the entry for annual
frequency is 1 as a default representing a large number of brief
recordkeeping occasions.

In many rows of tables 18 and 19, we list a burden under a single
provision that covers the written procedures or records described in
several provisions.  The burden of the master manufacturing record
listed in table 18 under final § 111.210 includes the burden for final
§ 111.205 because the master manufacturing record must include those
written procedures.  Similarly, the burden of the batch production
records listed in table 19 under final § 111.260 includes the burden
for records listed under final § 111.255 because the batch production
records must include those records.

The annual frequency for batch production records (and other records
kept on a batch basis in table 19) equals the annual number of batches.
The estimated burden for records kept by batch includes both records
kept for every batch and records kept for some but not all batches.  We
use the annual number of batches as the frequency for records that will
not necessarily be kept for every batch, such as test results or
material review and disposition records, because such records are part
of records, if they are necessary, that will be kept for every batch.

We estimate the burden of this collection of information as follows:

Table 18.--Estimated One-Time Burden to Establish Written Procedures1

21 CFR Section	Number of Recordkeepers	Annual Frequency per
Recordkeeping	Total Records	Hours per Record	Total Hours2

111.14	15,000	1	15,000	3.6	54,000

111.23	15,000	1	15,000	1	15,000

111.35	400	1	400	36	14,4000

111.95	250	1	250	686	176,5000

111.140	300	1	300	10.7	3,21000

111.180	200	1	200	10	2,000

111.210	250	1	250	12	3,000

111.325	150	1	150	454	67,6000

111.375	260	1	260	9	2,34000

111.430	250	1	250	12.6	3,15000

111.475	15,000	1	15,000	2.1	320,000

111.535	200	1	200	6	1,2000

111.570	30240	1	30240	121	3,3000

Total

	1547,7000

1There are no capital costs or operating costs associated with the
collection of information under this final rule.

Table 19.--Estimated Annual Recordkeeping Burden1

21 CFR Section	Number of Recordkeepers	Annual Frequency per
Recordkeeping	Total Annual Records	Hours per Record	Total Hours

111.14	15,000	4	60,000	1	60,000

111.23	15,000	1	15,000	0.2	3,000

111.35	400	1 	400	12.5	45,8000

111.95 	250	1	250	45	11,25000

111.140	240	1408163	337280,92000	1	337280,92000

111.180	240	1408163	337280,92000	1	337280,92000

111.210	240	1	240	2.54	5761,000

111.260	17045	1408	23906,36000	1	23906,36000

111.325	120	1	120	15	21,8000

111.375	260	1	260	1.82	4681,000

111.430	50	1	150	12.6	6301,000

111.475	15,000	1	15,000	0.4	6,000

111.535	110	4	440	173.5	76,48000

111.570	2540	76040	17644,000	0.5	8872,000

Total

	1,099933,204000

1There are no capital costs or operating costs associated with the
collection of information under this final rule.

The burden estimates above are based on our institutional experience
with other CGMP requirements and on data provided by Research Triangle
Institute (RTI) in the “Survey of Manufacturing Practices in the
Dietary Supplement Industry” (Refs. E1 and E2).

The estimates in both tables of the number of firms affected by each
provision of the rule are based on the percentage of manufacturers,
packagers, labelers, holders, distributors, and warehousers that
reported in the survey that they have not established written SOPs or do
not maintain records that would be required under the final rule.
Because we do not have survey results for general warehouses, we entered
the approximate number of facilities in that category for those
provisions covering general facilities.  For the dietary supplement
industry, the survey estimated that 1,460 firms would be covered by this
final rule, including manufacturers, packagers, labelers, holders,
distributors, and warehousers.  The time estimates include the burden
involved in documenting that certain requirements are performed and in
recordkeeping.  We used an estimated annual batch production of 1,408
batches per year to estimate the burden of requirements that are related
to the number of batches produced annually, such as final § 111.260,
“What must batch production record include?”.  The estimate of 1,408
batches per year is near the midpoint of the number of annual batches
reported by survey firms.

The length of time that CGMP records must be maintained is set forth in
final § 111.605.  Tables 18 and 19 reflect the estimated burdens for
written procedures, record maintenance, periodically reviewing records
to determine if they may be discarded, and for any associated
documentation for that activity for records that will be required under
part 111.  We have not included a separate estimate of burden for those
sections that require maintaining records in accordance with final §
111.605, but have included those burdens under specific provisions for
keeping records.  For example, final § 111.255(a) requires that the
batch production records be prepared every time a batch is manufactured,
and final § 111.255(d) requires that batch production records be kept
in accordance with final § 111.605.  The estimated burdens for both §
111.255(a) and (d) are included under final § 111.260 (what the batch
record must include).

The information collection provisions of this final rule have been
submitted to OMB for review.

Prior to the effective date of this final rule, we will publish a
document in the Federal Register announcing OMB’s decision to approve,
modify, or disapprove the information collection provisions in this
final rule.  An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a
currently valid OMB control number.

HHS/FDA-Internal-Deliberative–Confidential

Final PRA 9-28-05, 6-26-06

Page   PAGE  961


[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39148-39149]
[FR Doc No: 2018-16971]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Release From Federal Surplus Property and Grant
Assurance Obligations at Daniel K. Inouye International Airport (HNL),
Honolulu, Hawaii

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of request to release airport land.

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SUMMARY: The Federal Aviation Administration (FAA) proposes to rule and
invites public comment on the

application for a release of approximately 9.34 acres of airport
property at the Daniel K. Inouye International Airport (HNL), Honolulu,
Hawaii from all federal obligations contained in the Quitclaim Deed,
dated April 18, 2000, and Grant Assurances because the portion of land
is not needed for airport purposes. The land requested to be released
is located approximately one mile east of the airport completely
separated by a lagoon and the Sand Island Access Road, a major public
roadway. The release will allow the State of Hawaii (State) to transfer
the property from the State Airports Division at fair market value to
the State Highways and Harbors Divisions, thereby benefiting the
Airport and serving the interest of civil aviation. The proposed use of
the land after the transfer of jurisdiction will be compatible with the
airport and will not interfere with the airport or its operation.

DATED:  Comments must be received on or before September 7, 2018.

FOR FURTHER INFORMATION CONTACT: Comments on the request may be mailed
or delivered to the FAA at the following address: Mr. Gordon Wong,
Manager, Federal Aviation Administration, Honolulu Airports District
Office, Federal Register Comment, 300 Ala Moana Boulevard, Honolulu, HI
96850-0001. In addition, one copy of the comment submitted to the FAA
must be mailed or delivered to Jade T. Butay, Director of
Transportation, State of Hawaii, Department of Transportation, 869
Punchbowl Street, Honolulu, HI 96813-5097.

SUPPLEMENTARY INFORMATION: In accordance with the Wendell H. Ford
Aviation Investment and Reform Act for the 21st Century (AIR 21),
Public Law 106-181 (Apr. 5, 2000; 114 Stat. 61), this notice must be
published in the Federal Register 30 days before the Secretary may
waive any condition imposed on a federally obligated airport by surplus
property conveyance deeds or grant agreements.
    The following is a brief overview of the request:
    The State of Hawaii requested a release from public airport
purposes and grant assurance obligations for approximately 9.34 acres
of airport land from the 11.34-acre site to allow for its sale and a
land-use change to use for other than aeronautical purposes on the
remaining approximately 2.0 acres of airport property. In 1989,
Congress authorized conveying the 11.34 acres land to the State of
Hawaii under Public Law 101-189, Section 2814, Land Conveyances,
Kapalama Military Reservation, Hawaii. Under Governor's Executive Order
No. 4454 dated April 25, 2014, the 11.34-acre parcel was set aside to
the State of Hawaii, Department of Transportation for public airport
purposes. The land is located approximately one mile east of the
airfield, outside of the airport, separated by the Keehi Lagoon, and
the Sand Island Access Road. The land has been utilized for industrial
warehouse operations during most of the past ten years and is currently
vacant. The land no longer serves an airport purpose.
    The State of Hawaii will transfer the Airports Division's
jurisdiction of approximately 8.37 acres parcel to the State Harbors
Division and approximately 0.97 acres of property to the State Highways
Division totaling approximately 9.34 acres for fair market value
compensation. The Airports Division will retain and lease the remaining
2.0 acres of the land for fair market rental value for non-aeronautical
revenue producing purposes.
    The sales proceeds and rental income will be devoted to airport
operations and capital projects. The reuse of the property will not
interfere with the airport or its operation; thereby, serve the
interests of civil aviation.

    Issued in Honolulu, Hawaii, on July 30, 2018.
Gordon Wong,
Manager, Honolulu Airports District Office, Western-Pacific Region.
[FR Doc. 2018-16971 Filed 8-7-18; 8:45 am]
 BILLING CODE 4910-13-P


From:	Patricia Grim/DC/USEPA/US

To:	Mariana Cubeddu/DC/USEPA/US@EPA

Cc:	Mary Henigin/DC/USEPA/US@EPA, Joseph-J Dougherty/DC/USEPA/US@EPA,
Nathaniel Jutras/DC/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA,
Scott Jenkins/RTP/USEPA/US@EPA

Date:	12/18/2009 12:38 PM

Subject:	RIA for NO2 Primary NAAQS; SAN 5111 - Electronic Version

Hi Mariana,

Re-sending the RIA for above referenced rule.  This was provided to Nate
last Wednesday.

Here's the NO2 NAAQS RIA so you have it at the ready when the NAAQS
package is ready to go to OMB:

Patricia Grim

Washington Operations

Office of Air Quality Planning and Standards

Office of Air and Radiation

Room 5449F, Ariel Rios North

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>


[Federal Register Volume 77, Number 172 (Wednesday, September 5, 2012)]
[Proposed Rules]
[Pages 54495-54499]
[FR Doc No: 2012-21760]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-0623]
RIN 1625-AA11

Regulated Navigation Area; Thames River Degaussing Range
Replacement Operations; New London, CT

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a regulated navigation
area (RNA) on the navigable waters of the Thames River in New London
Harbor, New London, CT. The proposed RNA would establish speed and wake
restrictions as well as allow the Coast Guard to prohibit all vessel
traffic through the RNA during degaussing range replacement operations,
both planned and unforeseen, that could pose an imminent hazard to
persons and vessels operating in the area. This rule is necessary to
provide for the safety of life on the navigable waters during the
replacement of the degaussing range and its supporting system.

DATES: Comments and related material must be received by the Coast
Guard on or before October 5, 2012.
    Requests for public meetings must be received by the Coast Guard on
or before September 17, 2012.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: 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. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Joseph Graun, Prevention Department, U.S.
Coast Guard Sector Long Island Sound,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or

Lieutenant Isaac M. Slavitt, Waterways Management, U.S. Coast Guard
First District,<PHONE_NUMBER>. 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:

Table of Acronyms

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
RNA Regulated Navigation Area

A. 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.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, 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 at
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, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2012-0623) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. 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,
type the docket number (USCG-2012-0623) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. 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.

3. 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).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before September 17, 2012, using one of the
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.

B. Basis and Purpose

    Under the Ports and Waterways Safety Act, the Coast Guard has the
authority to establish RNAs in defined water areas that are determined
to have hazardous conditions and in which vessel traffic can be
regulated in the interest of safety. See 33 U.S.C. 1231 and Department
of Homeland Security Delegation No. 0170.1.
    This proposal would establish speed and wake restrictions as well
as allow the Coast Guard to prohibit all vessel traffic through the RNA
during degaussing range replacement operations, both planned and
unforeseen, that could pose an imminent hazard to persons and vessels
operating in the area. The Coast Guard is not now planning (and will
actively avoid) full closures of the waterway; however, given the
nature of the work it is important that this regulatory tool be
available if circumstances change. This rule is necessary to provide
for the safety of life on the navigable waters during the replacement
of the degaussing range and its supporting system.

C. Discussion of Proposed Rule

    The U.S. Navy operates a fixed degaussing range in New London
Harbor, New London, CT. This range is buried in sand on the bottom of
the Thames River federal navigation channel southeast of Fort Trumbull
State Park. The Navy uses this range to decrease unwanted magnetic
fields in Navy vessels. On NOAA Charts, the degaussing range is
outlined with a black dotted line and labeled ``Degaussing Range''. The
associated system of sensors and cables encompasses a much larger area
of the river bottom, from the river's west shore by Fort Trumbull State
Park southeasterly across the river to the river's eastern bank. On
NOAA Charts, this supporting system's boundaries are outlined with a
magenta dotted line and labeled ``Cable Area''. The Navy is preparing
to replace this range with new sensors, cables and supporting
equipment. The replacement project is projected to last between four
and six months, and is scheduled to begin on or about November 1, 2012.
    The Coast Guard is not now planning (and will actively avoid) full
closures of the waterway; however, given the nature of the work it is
important that this regulatory tool be available if circumstances
change. The Coast Guard attended the project's ``95% Design Review
Meeting'' hosted by the U.S. Navy on April 17, 2012 in New London, CT.
During the meeting, the Navy presented the project design and an
overview of what operations must take place in order to complete the
project. The Coast Guard discussed this project with the Navy to
identify whether the project can be completed without channel closures.
While the majority of the project will be completed without the need
for full closures, the possibility remains that certain tasks will
require closing the waterway due to the location of the degaussing
range directly under the navigation channel.
    The new trench will be located adjacent to the current degaussing
range within the navigation channel. Excavating the trench and
replacing equipment and cables will require barges and equipment to
take up a portion of the channel while they perform various operations
including excavating, diving, laying cables, and placing sensors. This
process will be

extremely complex and involves many safety hazards. In order to
minimize safety hazards, the Coast Guard proposes to make the ``Cable
Area'' (which includes the ``Degaussing Range'') a temporary RNA.
    This RNA would allow the Captain of the Port Sector Long Island
Sound (COTP) to establish speed and wake restrictions and to prohibit
vessel traffic on this portion of the river for limited periods when
necessary for the safety of vessels and workers during construction
work in the channel. The Coast Guard would enforce a five knot speed
limit and ``NO WAKE'' zone and be able to close the designated area to
all vessel traffic during any circumstance, planned or unforeseen, that
poses an imminent threat to waterway users or construction operations
in the area. Complete waterway closures would be minimized to that
period absolutely necessary and made with as much advanced notice as
possible.
    Entry into, anchoring or movement within this proposed RNA during a
closure would be prohibited unless authorized by the COTP or a
designated representative. In the event of an emergency, all
construction equipment would need to be vacated for emergency vessels
(i.e. Fire Rescue Boat, Marine Police Boat, or Environmental Response
Boat).
    This project is expected to be completed within a four to six month
period. However, in order to prepare for project delays associated with
inclement weather, permitting and other circumstance we propose a
twenty-four month effective period for the RNA from November 1, 2012
until October 31, 2014.
    The project currently faces several factors that could lead to
delays. A project coordinator has not yet been identified.
Additionally, as of July 2012 state environmental and Army Corps of
Engineers permits have not been requested by the Navy. These permits
can take several months to obtain and once obtained may include
restrictions on certain underwater activities. The Navy will not know
the extent of all restrictions until the permits are issued.
    If the project is completed before October 31, 2014, the COTP could
suspend enforcement of the RNA. The COTP would ensure that notice of
the suspension of enforcement reached affected segments of the public
by all appropriate means. Such means of notification could include, but
would not be limited to, Broadcast Notice to Mariners and Local Notice
to Mariners.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The Coast Guard determined that this rulemaking would not be a
significant regulatory action for the following reasons: vessel traffic
would only be excluded from the RNA for limited durations (if at all),
and speed and wake restrictions are not unduly restrictive, and the RNA
covers a small geographic area. Advanced public notifications would
also be made to local mariners through appropriate means, which could
include, but would not be limited to, Local Notice to Mariners and
Broadcast Notice to Mariners.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
would not have a significant economic impact on a substantial number of
small entities. This rule would affect the following entities, some of
which may be small entities: the owners or operators of vessels
intending to enter or transit within the regulated areas during a
vessel restriction period.
    The RNA would not have a significant economic impact on a
substantial number of small entities for the following reasons: vessel
traffic would only be excluded from the RNA for limited durations (if
at all), and speed and wake restrictions are not unduly restrictive,
and the RNA covers a small geographic area. Additionally, before the
effective period of a waterway closure, advanced public notifications
would be made to local mariners through appropriate means, which could
include, but would not be limited to, Local Notice to Mariners and
Broadcast Notice to Mariners.
    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.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or

more in any one year. Though this proposed rule would not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children From Environmental Health Risks

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

11. Indian Tribal Governments

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

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use 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.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. This proposed rule
involves restricting vessel movement within a regulated navigation
area. This rule is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A
preliminary environmental analysis checklist supporting this
determination is available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

    2. Add Sec.  165.T01-0623 to read as follows:

Sec.  165.T01-0623  Regulated Navigation Area: Thames River, New
London, CT.

    (a) Location. The following area is a regulated navigation area:
All navigable waters of the Thames River adjacent to Fort Trumbull
State Park in New London, CT, from surface to bottom bounded to the
north by a line connecting the following points: Point ``1'',
41[deg]20'40'' N, 072[deg]05'32'' W east to point ``2'', 41[deg]20'40''
N, 072[deg]05'15'' W then southeast to point ``3'', 41[deg]20'31.8'' N,
072[deg]05'03'' W then south to point ``4'', 41[deg]20'28'' N,
072[deg]05'03'' W then east to point ``5'', 41[deg]20'30'' N,
072[deg]04'48'' W; bounded to the east by following the shoreline south
from point ``5'' to point ``6'', 41[deg]20'19'' N, 072[deg]04'46'' W;
bounded to the south by a line connecting the following points: point
``6'' west to point ``7'', 41[deg]20'17'' N, 072[deg]05'13'' W then
north to point ``8'' 41[deg]20'27.2'' N, 072[deg]05'15'' W then
northwest to point ``9'' 41[deg]20'29.5'' N, 072[deg]05'17'' W then
west to point ``10'' 41[deg]20'29.5'' N, 072[deg]05'30'' W then
northwest to point ``11'' 41[deg]20'31'' N, 072[deg]05'34'' W; bounded
to the west by following the shoreline north from point ``11'' back to
the start, point ``1''.
    (b) Regulations. (1) The general regulations contained in 33 CFR
165.10, 165.11, and 165.13 apply.
    (2) In accordance with the general regulations, entry into,
anchoring, or movement within this zone, during periods of enforcement,
is prohibited unless authorized by the Captain of the Port Long Island
Sound (COTP) or the COTP's designated representative.
    (3) During periods of enforcement, a speed limit of five knots will
be in effect within the regulated area and all vessels must proceed
through the area with caution and operate in such a manner as to
produce no wake.
    (4) During periods of enforcement, all persons and vessels must
comply with all orders and directions from the COTP or the COTP's
designated representative.
    (5) During periods of enforcement, upon being hailed by a U.S.
Coast Guard vessel by siren, radio, flashing light or other means, the
operator of the vessel must proceed as directed.
    (6) Persons and vessels may request permission to enter the zone
during periods of enforcement on VHF-16 or via phone at<PHONE_NUMBER>.
    (7) Notwithstanding anything contained in this rule, the Rules of
the Road (33 CFR part 84--Subchapter E, inland navigational rules) are
still in effect and should be strictly adhered to at all times.
    (c) Effective Period. This rule is effective from November 1, 2012
until October 31, 2014.
    (d) Enforcement Period. (1) Except when suspended in accordance
with paragraph (d)(2) of this section, this regulated navigation area
is in force 24 hours a day from November 1, 2012 until October 31,
2014.
    (2) Notice of suspension of enforcement: The COTP may suspend
enforcement of the regulated navigation area. If enforcement is
suspended, the COTP will cause notice of the suspension of enforcement
to be made by all appropriate means to the affected segments of the
public. Such means of notification may include, but are not limited to,
Broadcast Notice to Mariners

and Local Notice to Mariners. Such notifications will include the date
and time that enforcement is suspended as well as the date and time
that enforcement will resume.
    (3) Violations of this regulated navigation area should be reported
to the COTP, at<PHONE_NUMBER> or on VHF-Channel 16. Persons in violation
of this regulated navigation area may be subject to civil or criminal
penalties.

    Dated: August 22, 2012.
D.B. Abel,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2012-21760 Filed 9-4-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Rules and Regulations]
[Pages 57291-57293]
[FR Doc No: 2015-24164]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 23

[Docket No.FAA-2015-0721; Notice No. 23-269-SC]

Special Conditions: Honda Aircraft Company, Model HA-420
HondaJet, Lithium-ion Batteries

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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

SUMMARY: These special conditions are issued for the Honda Aircraft
Company, Model HA-420 airplane. This airplane will have a novel or
unusual design feature associated with the installation of lithium-ion
(Li-ion) batteries. The applicable airworthiness regulations do not
contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: These special conditions are effective September 23, 2015.

FOR FURTHER INFORMATION CONTACT: Les Lyne, Policies & Procedures
Branch, ACE-114, Federal Aviation Administration, Small Airplane
Directorate, Aircraft Certification Service, 901 Locust; Kansas City,
Missouri 64106; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On October 11, 2006, Honda Aircraft Company applied for a type
certificate for their new Model HA-420. On October 10, 2013, Honda
Aircraft Company requested an extension with an effective application
date of October 1, 2013. This extension changed the type certification
basis to amendment 23-62.
    The HA-420 is a four to five passenger (depending on
configuration), two crew, lightweight business jet with a 43,000-foot
service ceiling and a maximum takeoff weight of 9963 pounds. The
airplane is powered by two GE-Honda Aero Engines (GHAE) HF-120 turbofan
engines.
    The current regulatory requirements for part 23 airplanes do not
contain adequate requirements for the application of Li-ion batteries
in airborne applications. This type of battery possesses certain
failure, operational characteristics, and maintenance requirements that
differ significantly from that of the nickel cadmium and lead acid
rechargeable batteries currently approved in other normal, utility,
acrobatic, and commuter category airplanes. Therefore, the FAA is
proposing this special condition to require that (1) all
characteristics of the rechargeable lithium batteries and their
installation that could affect safe operation of the HA-420 are
addressed, and (2) appropriate Instructions for Continued Airworthiness
which include maintenance requirements are established to ensure the
availability of electrical power from the batteries when needed.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, Honda Aircraft Company must
show that the HA-420 meets the applicable provisions of part 23, as
amended by Amendments 23-1 through 23-62 thereto.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 23) do not contain adequate or
appropriate safety standards for the HA-420 because of a novel or
unusual design feature, special conditions are prescribed under the
provisions of Sec.  21.16.
    In addition to the applicable airworthiness regulations and special
conditions, the HA-420 must comply with the fuel vent and exhaust
emission requirements of 14 CFR part 34 and the noise certification
requirements of 14 CFR part 36, and the FAA must issue a finding of
regulatory adequacy under section 611 of Public Law 92-574, the ``Noise
Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.

Novel or Unusual Design Features

    The HA-420 will incorporate the following novel or unusual design
feature: The installation of Li-ion batteries.
    The current regulatory requirements for part 23 airplanes do not
contain adequate requirements for the application of Li-ion batteries
in airborne applications. This type of battery possesses certain
failure, operational characteristics, and maintenance requirements that
differ significantly from that of the nickel cadmium and lead acid
rechargeable batteries currently approved in other normal, utility,
acrobatic, and commuter category airplanes.

Discussion

    The applicable parts 21 and 23 airworthiness regulations governing
the installation of batteries in general aviation airplanes, including
Sec.  23.1353, were derived from Civil Air Regulations (CAR 3) as part
of the recodification that established 14 CFR part 23. The battery
requirements, which are identified in Sec.  23.1353, were a rewording
of the CAR requirements that did not add any substantive technical
requirements. An increase in incidents involving battery fires and
failures that accompanied the increased use of Nickel-Cadmium (Ni-Cad)
batteries in aircraft resulted in rulemaking activities on the battery
requirements for transport category airplanes. These regulations were
incorporated into Sec.  23.1353(f) and (g), which apply only to Ni-Cad
battery installations.
    The use of Li-ion batteries on the HA-420 airplane has prompted the
FAA to review the adequacy of the existing battery regulations with
respect to that chemistry. As the result of this review, the FAA has
determined that the existing regulations do not adequately address
several failure, operational, and maintenance characteristics of Li-ion
batteries that could affect safety of the

battery installation of the HA-420 airplane electrical power supply.
    The introduction of Li-ion batteries into aircraft raises some
concern about associated battery/cell monitoring systems and how these
may affect utilization of an otherwise ``good'' battery as an energy
source to the electrical system when monitoring components fail.
Associated battery/cell monitoring systems (i.e., temperature, state of
charge, etc.) should be evaluated/tested with respect the expected
extremes in the aircraft operating environment.
    Li-ion batteries typically have different electrical impedance
characteristics than lead-acid or Ni-Cad batteries. Honda Aircraft
Company needs to evaluate other components of the aircraft electrical
system with respect to these characteristics.
    At present, there is very limited experience regarding the use of
Li-ion rechargeable batteries in applications involving commercial
aviation. However, other users of this technology range from wireless
telephone manufacturers to the electric vehicle industry and have noted
significant safety issues regarding the use of these types of
batteries, some of which are described in the following paragraphs:
    1. Overcharging. In general, lithium batteries are significantly
more susceptible to internal failures that can result in self-
sustaining increases in temperature and pressure (i.e., thermal
runaway) than their nickel-cadmium or lead-acid counterparts. This is
especially true for overcharging, which causes heating and
destabilization of the components of the cell, leading to the formation
(by plating) of highly unstable metallic lithium. The metallic lithium
can ignite, resulting in a self-sustaining fire or explosion. Finally,
the severity of thermal runaway due to overcharging increases with
increasing battery capacity due to the higher amount of electrolyte in
large batteries.
    2. Over-discharging. Discharge of some types of lithium battery
cells beyond a certain voltage (typically 2.4 volts) can cause
corrosion of the electrodes of the cell; resulting in loss of battery
capacity that cannot be reversed by recharging. This loss of capacity
may not be detected by the simple voltage measurements commonly
available to flight crews as a means of checking battery status--a
problem shared with nickel-cadmium batteries.
    3. Flammability of Cell Components: Unlike nickel-cadmium and lead-
acid batteries, some types of lithium batteries use liquid electrolytes
that are flammable. The electrolyte can serve as a source of fuel for
an external fire if there is a breach of the battery container.
    These safety issues experienced by users of lithium batteries raise
concern about the use of these batteries in commercial aviation. The
intent of the special condition is to establish appropriate
airworthiness standards for lithium battery installations in the HA-420
and to ensure, as required by Sec. Sec.  23.1309 and 23.601, that these
battery installations are not hazardous or unreliable.
    Additionally, RTCA, in a joint effort with the FAA and industry,
has released RTCA/DO-311, Minimum Operational Performance Standards for
Rechargeable Lithium Battery Systems, which gained much of its text
directly from previous Li-ion special conditions. Honda Aircraft
Company proposes to use DO-311 as the primary methodology for assuring
the battery will perform its intended functions safely as installed in
the HA-420 airplane and as the basis for test and qualification of the
battery. This Special Condition incorporates applicable portions of DO-
311.

Discussion

    Notice of proposed special conditions No. 23-15-03-SC for the Honda
Aircraft Company, Model HA-420 airplane was published in the Federal
Register on April 14, 2015 (80 FR 19889). No comments were received,
and the special conditions are adopted as proposed.

Applicability

    As discussed above, these special conditions are applicable to the
HA-420. Should Honda Aircraft Company apply at a later date for a
change to the type certificate to include another model incorporating
the same novel or unusual design feature, the special conditions would
apply to that model as well.
    Under standard practice, the effective date of final special
conditions would be 30 days after the date of publication in the
Federal Register; however, as the certification date for the Honda
Aircraft Company HA-420 is imminent, the FAA finds that good cause
exists to make these special conditions effective upon issuance.

Conclusion

    This action affects only certain novel or unusual design features
on one model of airplanes. It is not a rule of general applicability
and it affects only the applicant who applied to the FAA for approval
of these features on the airplane.

List of Subjects in 14 CFR Part 23

    Aircraft, Aviation safety, Signs and symbols.

Citation

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704, 14 CFR
21.16 and 14 CFR 11.38 and 11.19.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Honda Aircraft Company, HA-420
airplanes.

1. Lithium-Ion Battery Installation

    a. Safe cell temperatures and pressures must be maintained during
any probable charging or discharging condition, or during any failure
of the charging or battery monitoring system not shown to be extremely
remote. The applicant must design Li-ion battery installation to
preclude explosion or fire in the event of those failures.
    b. The applicant must design the Li-ion batteries to preclude the
occurrence of self-sustaining, uncontrolled increases in temperature or
pressure.
    c. No explosive or toxic gasses emitted by any Li-ion battery in
normal operation or as the result of any failure of the battery
charging or monitoring system, or battery installation not shown to be
extremely remote, may accumulate in hazardous quantities within the
airplane.
    d. Li-ion batteries that contain flammable fluids must comply with
the flammable fluid fire protection requirements of Sec.  23.863(a)
through (d).
    e. No corrosive fluids or gasses that may escape from any Li-ion
battery may damage surrounding airplane structure or adjacent essential
equipment.
    f. The applicant must provide provision for each installed Li-ion
battery to prevent any hazardous effect on structure or essential
systems that may be caused by the maximum amount of heat the battery
can generate during a short circuit of the battery or of its individual
cells.
    g. Li-ion battery installations must have--
    (1) A system to control the charging rate of the battery
automatically so as to prevent battery overheating or overcharging; or
    (2) A battery temperature sensing and over-temperature warning
system with a means for automatically disconnecting the battery from
its charging source in the event of an over-temperature condition; or

    (3) A battery failure sensing and warning system with a means for
automatically disconnecting the battery from its charging source in the
event of battery failure.
    h. Any Li-ion battery installation whose function is required for
safe operation of the airplane, must incorporate a monitoring and
warning feature that will provide an indication to the appropriate
flightcrew members whenever the capacity and State of Charge (SOC) of
the batteries have fallen below levels considered acceptable for
dispatch of the airplane.
    i. The Instructions for Continued Airworthiness (ICA) must contain
recommended manufacturers maintenance and inspection requirements to
ensure that batteries, including single cells, meet a safety function
level essential to the aircraft's continued airworthiness.
    (1) The ICA must contain operating instructions and equipment
limitations in an installation maintenance manual.
    (2) The ICA must contain installation procedures and limitations in
a maintenance manual, sufficient to ensure that cells or batteries,
when installed according to the installation procedures, still meet
safety functional levels essential to the aircraft's continued
airworthiness. The limitations must identify any unique aspects of the
installation.
    (3) The ICA must contain corrective maintenance procedures to check
battery capacity at manufacturers recommended inspection intervals.
    (4) The ICA must contain scheduled servicing information to replace
batteries at manufacturers recommended replacement time.
    (5) The ICA must contain maintenance and inspection requirements to
check visually for battery and/or charger degradation.
    j. Batteries in a rotating stock (spares) that have experienced
degraded charge retention capability or other damage due to prolonged
storage must be functionally checked at manufacturers recommended
inspection intervals.
    k. The System Safety Assessment (SSA) process should address the
software and complex hardware levels for the sensing, monitoring, and
warning systems if these systems contain complex devices. The
functional hazard assessment (FHA) for the system is required based on
the intended functions described. The criticality of the specific
functions will be determined by the safety assessment process for
compliance with Sec.  23.1309. Advisory Circular 23-1309-1C contains
acceptable means for accomplishing this requirement. For determining
the failure condition, the criticality of a function will include the
mitigating factors. The failure conditions must address the loss of
function and improper operations.

    Issued in Kansas City, Missouri, on September 14, 2015.
Mel Johnson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-24164 Filed 9-22-15; 8:45 am]
 BILLING CODE 4910-13-P