[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Rules and Regulations]
[Page 72357-72358]
[DOCID:fr28no08-18]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA-2007-29083; Docket No. NHTSA-2007-28707]

Federal Motor Vehicle Safety Standards: Tires; Correction,
Occupant Crash Protection; Correction

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Final rule; correcting amendments.

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SUMMARY: This document corrects Federal Motor Vehicle Safety Standard
(FMVSS) No. 139, New pneumatic radial tires for light vehicles, which
specifies tire dimensions, test requirements, and labeling requirements
and which defines tire load ratings for certain types of light vehicle
tires. The corrections relate to a definition for snow tires and tire
marking requirements, which were inadvertently removed. This document
also corrects FMVSS No. 208, Occupant Crash Protection, with respect to
specifying a test tolerance for a procedure used to test air bag
suppression systems and low risk deployment systems.

DATES: Effective December 29, 2008.

FOR FURTHER INFORMATION CONTACT: Ms. Rebecca Yoon, Office of the Chief
Counsel, by telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, or
by mail at the following address: National Highway Traffic Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION:

FMVSS No. 139

    FMVSS No. 139 specifies tire dimensions, test requirements, and
labeling requirements, and defines tire load ratings for new pneumatic
radial tires for use on certain motor vehicles that have a gross
vehicle weight rating (GVWR) of 10,000 pounds or less. The tire
labeling requirements, S5.5(a) through (h) of the standard, were
originally added to FMVSS No. 139 in November 2002 to maintain
consistent labeling requirements for all tires for use on light
vehicles.\1\
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    \1\ 67 FR 69600 (Nov. 18, 2002).
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    S5.5(i), concerning the ``Alpine Symbol'' for snow tires, was added
to FMVSS No. 139 in January 2006 to allow manufacturers to certify snow
tires to special requirements for snow tires, and to help consumers
identify those tires.\2\ However, the January 2006 amendments adding
S5.5(i) inadvertently did not reference this subparagraph (i) in the
introductory paragraph of S5.5. To correct that oversight, the agency
issued an August 2007 final rule intending to amend only the
introductory paragraph of S5.5 to specify that the subparagraphs
included (a) through (i).\3\ However, the rule inadvertently removed
the nine subparagraphs (a) through (i) of S5.5. This document corrects
the CFR by adding the inadvertently removed paragraphs of FMVSS No.
139.
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    \2\ 71 FR 877 (Jan. 6, 2006).
    \3\ 72 FR 49207, 49209-10 (Aug. 28, 2007).
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    Additionally, in the August 2007 final rule, the agency added a
definition for ``light truck (LT) tires'' but inadvertently removed the
definition of ``snow tire'' from the list of definitions in S3. The
``snow tire'' definition is needed in the standard to make clearer how
the standard applies to snow tires. This document corrects the CFR by
adding the inadvertently removed snow tire definition.
    We are also correcting FMVSS No. 139 to address another labeling
requirement that had been inadvertently omitted from the standard when
labeling requirements were moved from FMVSS No. 119 to FMVSS No. 139.
This was the requirement that light truck tires load range C, D, and E
be labeled with the tire load range designation on both sides of the
tire. The agency did not intend to change (delete) the requirement then
in FMVSS No. 119 that the tire load range designation be labeled on the
tires.\4\ Today's document reinstates the labeling requirement.
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    \4\ Notice of proposed rulemaking (NPRM), 66 FR 65536, December
19, 2001. The only change to FMVSS No. 119 labeling requirements
discussed in the preamble of the NPRM related to locating the type
of ply, cord, and tube on one sidewall only, rather than both sides.
66 FR at 65564. Current tires are labeled with the C, D, and E tire
load range designation on both sides of the tire.
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FMVSS No. 208

    FMVSS No. 208 requires passenger vehicles to be equipped with seat
belts and frontal air bags for the protection of vehicle occupants in
crashes. On July 24, 2007, NHTSA issued a final rule that established
test procedures for installing child restraint systems (CRSs) to a
child restraint anchorage system in a front passenger seating position
in vehicles certified to meet advanced air bag requirements through the
use of a suppression system or low risk deployment system.\5\
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    \5\ 72 FR 40252.
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    As part of the procedure for installing child restraints with a
rigid ratchet mechanism built into the CRS, the agency stated in the
preamble that a force of 475 25 Newtons (N) will be applied
to the CRS (72 FR at 40256, columns 1 and 2). However, S<IP_ADDRESS>.2(g)
and S<IP_ADDRESS>.2(h) of the regulatory text inadvertently did not specify
the tolerance of 25 N. The lack of a specified tolerance
may prove to be misleading and needs to be clarified. This document
corrects the CFR by adding the 25 N tolerance to those
sections of the standard.

List of Subjects in 49 CFR Part 571

    Motor vehicles, Motor vehicle safety; Reporting and recordkeeping
requirements; Tires.

0
Accordingly, 49 CFR part 571 is corrected by making the following
correcting amendments:

PART 571--[CORRECTED]

0
1. The authority citation for part 571 continues to read as follows:

    Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166;
delegation of authority at 49 CFR 1.50.

0
2. Section 571.139 is amended by adding to S3, in alphabetical order, a
definition of ``Snow tire,'' and revising S5.5 to read as follows:

Sec.  571.139  Standard No. 139--New pneumatic radial tires for light
vehicles.

* * * * *
    S3. Definitions.
* * * * *
    Snow tire means a tire that attains a traction index equal to or
greater than 110, compared to the ASTM E-1136 Standard Reference Test
Tire when using the snow traction test as described in ASTM F-1805-00,
Standard Test Method for Single Wheel Driving Traction in a Straight
Line on Snow- and Ice-Covered Surfaces, and which is marked with an
Alpine Symbol specified in S5.5(i) on at least one sidewall.
* * * * *
    S5.5 Tire markings. Except as specified in paragraphs (a) through
(i) of S5.5, each tire must be marked on each sidewall with the
information specified in S5.5(a) through (d) and on one sidewall with
the information specified in S5.5(e) through (i) according to the
phase-in schedule specified in S7 of this standard. The markings must
be placed between the maximum section width and the bead on at least
one sidewall, unless the maximum section width of the tire is located
in an area that is not more than one-fourth of the distance from the
bead to the shoulder of the tire. If the maximum section width falls
within that area, those markings must appear between the bead and a
point one-half the distance from the bead to the shoulder of the tire,
on at least one sidewall. The markings must be in letters and numerals
not less than 0.078 inches high and raised above or sunk below the tire
surface not less than 0.015 inches.
    (a) The symbol DOT, which constitutes a certification that the tire
conforms to applicable Federal motor vehicle safety standards;
    (b) The tire size designation as listed in the documents and
publications specified in S4.1.1 of this standard;
    (c) The maximum permissible inflation pressure, subject to the
limitations of S5.5.4 through S5.5.6 of this standard;
    (d) The maximum load rating and for LT tires, the letter
designating the tire load range;
    (e) The generic name of each cord material used in the plies (both
sidewall and tread area) of the tire;
    (f) The actual number of plies in the sidewall, and the actual
number of plies in the tread area, if different;
    (g) The term ``tubeless'' or ``tube type,'' as applicable;
    (h) The word ``radial,'' if the tire is a radial ply tire; and
    (i) Alpine Symbol. A tire meeting the definition of a snow tire as
defined in paragraph S3 may, at the option of the manufacturer, show
the pictograph of a mountain with a snowflake as shown below. If the
manufacturer chooses to mark the snow tire with the alpine symbol, the
mountain profile must have a minimum base of 15 mm and a minimum height
of 15 mm, and must contain three peaks with the middle peak being the
tallest. Inside the mountain, there must be a six-sided snowflake
having a minimum height of one-half the tallest peak.
[GRAPHIC] [TIFF OMITTED] TR28NO08.009

* * * * *

0
3. Section 571.208 is amended by revising S<IP_ADDRESS>.2(g) and
S<IP_ADDRESS>.2(h), to read as follows:

Sec.  571.208  Standard No. 208; Occupant crash protection.

* * * * *
    S<IP_ADDRESS>.2 * * *
* * * * *
    (g) If the child restraint uses a linear sliding or ratcheting
mechanism that requires the application of force to securely install
the child restraint, within 255 seconds, apply a 47525N force, that has no lateral component, aligned angularly
10 degrees with a parallel plane located within 100 mm of the plane formed by the linear mechanism. Release the
force.
* * * * *
    S<IP_ADDRESS>.2 * * *
* * * * *
    (h) If the child restraint uses a linear sliding or ratcheting
mechanism that requires the application of force to securely install
the child restraint, within 255 seconds, apply a 47525N force, that has no lateral component, aligned angularly
10 degrees with a parallel plane located within 100 mm of the plane formed by the linear mechanism. Release the
force.
* * * * *

    Issued: November 21, 2008.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. E8-28096 Filed 11-26-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Notices]
[Page 5772-5774]
[DOCID:fr07fe07-156]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55197; File No. SR-BSE-2007-02]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend the Boston Options Exchange Fee Schedule

January 30, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 22, 2007, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the BSE.
The BSE has designated this proposal as one establishing or changing a
due, fee, or other charge imposed by the BSE under Section
19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
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\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes the following changes to the Fee Schedule for
the Boston Options Exchange (``BOX''). The first proposed change to the
Fee Schedule relates to the Penny Pilot Program.\5\ This proposed
change will allow BOX to introduce lower fees for those instruments
that are included in the Penny Pilot Program, which trade in increments
of one cent. The second proposed change is to amend the Fee Schedule to
permanently eliminate a fee that is currently waived. Finally, the

Exchange proposes to amend the Minimum Activity Charge (``MAC'')
contained in the BOX Fee Schedule. The proposed change is to account
for the effect that current market conditions have had on the MAC. The
text of the proposed rule change is available at the BSE, the
Commission's Public Reference Room, and http://www.bostonstock.com/legal/filings/07-02.pdf
.

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    \5\ See Securities Exchange Release No. 54789 (November 20,
2006), 71 FR 68654 (November 27, 2006) (SR-BSE-2006-49).
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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 BSE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The BSE has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes the following changes to the BOX Fee
Schedule. The first proposed change to the Fee Schedule relates to the
Penny Pilot Program. This proposed change will allow BOX to introduce
lower fees for those instruments that are included in the Penny Pilot
Program, which trade in increments of one cent. The second proposed
change is to amend the Fee Schedule to permanently eliminate a fee that
is currently waived. Finally, the Exchange proposes to amend the MAC
contained in the BOX Fee Schedule. The proposed change is to account
for the effect that current market conditions have had on the MAC. The
three proposed changes to the Fee Schedule are discussed in further
detail below.
(a) Reduction in Fees Related to the Penny Pilot Program
    The Exchange is proposing to lower fees for those instruments that
are included in the Penny Pilot Program, which trade in increments of
one cent. This proposed change will reduce the trading fees for those
instruments from the standard trading fee of $0.20 per contract traded
to a fee of $0.15 per contract traded. BOX believes that this reduction
in fees will encourage trading for those classes traded in the Penny
Pilot Program.
(b) Removal of Fee Which is No Longer Charged
    BOX does not currently charge the $0.40 per contract fee for
contracts for Broker Dealer Proprietary Accounts and Market Makers
traded against an order the Trading Host filters to prevent trading
through the NBBO. BOX proposes to delete the charge from the BOX Fee
Schedule to conform the Fee Schedule to reflect BOX's current practice.
The proposed change will accurately reflect the charges that BOX levies
on its Participants.\6\
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    \6\ The Exchange clarified that the $0.40 per contract fee is
being deleted from the Fee Schedule because BOX has been waiving the
fee for Broker Dealer Proprietary Accounts and Market Makers.
Telephone conference between Lisa Fall, General Counsel, BOX; Brian
Donnelly, Assistant Vice President, Regulation and Compliance, BSE;
David Liu, Senior Special Counsel, Commission; and Jan Woo,
Attorney, Commission, on January 26, 2007.
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(c) Changes to the MAC
    Recent increases in options trading have resulted in many BOX
listed classes to be reclassified into higher MAC categories. BOX is
seeking to amend its existing MAC program to provide uniform fee relief
to its Participants. The proposed change alters the month in which the
MAC reclassifications are calculated from January to July. The changes
to the MAC program are being proposed to prevent unnecessary fee
increases for BOX Participants.\7\ Moving the month of reclassification
to July will afford BOX the opportunity to keep the current MAC
classifications the same for an additional six months, thus keeping
fees to Participants the same.\8\ No changes are being sought to alter
the fundamental structure of the existing program.
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    \7\ The Exchange clarified that moving the reclassification to
July may provide relief to BOX Participants for six months. Id.
    \8\ Id.
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2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\9\ in general, and Section
6(b)(4) of the Act,\10\ in particular, which requires that an exchange
provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and issuers and other persons using its
facilities.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(2) \12\ thereunder
because it changes a fee imposed by the Exchange. At any time within 60
days of the filing of such proposed rule change, the Commission may
summarily abrogate 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.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 19b-4(f)(2).
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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 No. SR-BSE-2007-02 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-BSE-2007-02. 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 inspection and copying in the Commission's Public
Reference Room. Copies of such filing also will be available for
inspection and copying at the principal office of the BSE. 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-BSE-2007-02 and should be
submitted on or before February 28, 2007.
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    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-1944 Filed 2-6-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6926-6927]
[DOCID:fr11fe09-95]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59357; File No. SR-CBOE-2009-005]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Temporary Membership Status and Interim Trading
Permit Access Fees

 February 4, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on January 30, 2009, the
Chicago Board Options Exchange, Incorporated (``CBOE'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the CBOE. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
parties.
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    \1\ 15 U.S.C. 78s(b)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to adjust (i) the monthly access fee for persons
granted temporary CBOE membership status (``Temporary Members'')
pursuant to Interpretation and Policy .02 under CBOE Rule 3.19 (``Rule
3.19.02'') and (ii) the monthly access fee for Interim Trading Permit
(``ITP'') holders under CBOE Rule 3.27. The text of the proposed rule
change is available on the Exchange's Web site (http://www.cboe.org/
Legal/), at the Exchange's Office of the Secretary, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    The current access fee for Temporary Members under Rule 3.19.02 \2\
and the current access fee for ITP holders under Rule 3.27 \3\ are both
$10,175 per month. Both access fees are currently set at the indicative
lease rate (as defined below) for January 2009. The Exchange proposes
to adjust both access fees effective at the beginning of February 2009
to be equal to the indicative lease rate for February 2009 (which is
$10,471). Specifically, the Exchange proposes to revise both the
Temporary Member access fee and the ITP access fee to be $10,471 per
month commencing on February 1, 2009.
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    \2\ See Securities Exchange Act Release No. 56458 (September 18,
2007), 72 FR 54309 (September 24, 2007) (SR-CBOE-2007-107) for a
description of the Temporary Membership status under Rule 3.19.02.
    \3\ See Securities Exchange Act Release No. 58178 (July 17,
2008), 73 FR 42634 (July 22, 2008) (SR-CBOE-2008-40) for a
description of the Interim Trading Permits under Rule 3.27.
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    The indicative lease rate is defined under Rule 3.27(b) as the
highest clearing firm floating monthly rate \4\ of the CBOE Clearing
Members that assist in facilitating at least 10% of the CBOE
transferable membership leases.\5\ The Exchange determined the
indicative lease rate for February 2009 by polling each of these
Clearing Members and obtaining the clearing firm floating monthly rate
designated by each of these Clearing Members for that month.
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    \4\ Rule 3.27(b) defines the clearing firm floating monthly rate
as the floating monthly rate that a Clearing Member designates, in
connection with transferable membership leases that the Clearing
Member assisted in facilitating, for leases that utilize that
monthly rate.
    \5\ The concepts of an indicative lease rate and of a clearing
firm floating month rate were previously utilized in the CBOE rule
filings that set and adjusted the Temporary Member access fee. Both
concepts are also codified in Rule 3.27(b) in relation to ITPs.
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    The Exchange used the same process to set the proposed Temporary
Member and ITP access fees that it used to set the current Temporary
Member and ITP access fees. The only difference is that the Exchange
used clearing firm floating monthly rate information for the month of
February 2009 to set the proposed access fees (instead of clearing firm
floating monthly rate information for the month of January 2009 as was
used to set the current access fees) in order to take into account
changes in clearing firm floating monthly rates for the month of
February 2009.
    The Exchange believes that the process used to set the proposed
Temporary Member access fee and the proposed Temporary Member access
fee itself are appropriate for the same reasons set forth in CBOE rule
filing SR-CBOE-2008-12 with respect to the original Temporary Member
access fee.\6\ Similarly, the Exchange believes that the process used
to set the proposed ITP access fee and the proposed ITP access fee
itself are appropriate for the same reasons set forth in CBOE rule
filing SR-CBOE-2008-77 with respect to the original ITP access fee.\7\
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    \6\ See Securities Exchange Act Release No. 57293 (February 8,
2008), 73 FR 8729 (February 14, 2008) (SR-CBOE-2008-12), which
established the original Temporary Member access fee, for detail
regarding the rationale in support of the original Temporary Member
access fee and the process used to set that fee, which is also
applicable to this proposed change to the Temporary Member access
fee as well.
    \7\ See Securities Exchange Act Release No. 58200 (July 21,
2008), 73 FR 43805 (July 28, 2008) (SR-CBOE-2008-77), which
established the original ITP access fee, for detail regarding the
rationale in support of the original ITP access fee and the process
used to set that fee, which is also applicable to this proposed
change to the ITP access fee as well.

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    Each of the proposed access fees will remain in effect until such
time either that the Exchange submits a further rule filing pursuant to
Section 19(b)(3)(A)(ii) of the Act \8\ to modify the applicable access
fee or the applicable status (i.e., the Temporary Membership status or
the ITP status) is terminated. Accordingly, the Exchange may, and
likely will, further adjust the proposed access fees in the future if
the Exchange determines that it would be appropriate to do so taking
into consideration lease rates for transferable CBOE memberships
prevailing at that time.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    The procedural provisions of the CBOE Fee Schedule related to the
assessment of each proposed access fee are not proposed to be changed
and will remain the same as the current procedural provisions relating
to the assessment of that access fee.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\9\ in general, and furthers the
objectives of Section 6(b)(4) of the Act,\10\ in particular, in that it
is designed to provide for the equitable allocation of reasonable dues,
fees, and other charges among persons using its facilities.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE 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

    Because the foregoing rule change establishes or changes a due,
fee, or other charge imposed by the Exchange, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \11\ and subparagraph (f)(2)
of Rule 19b-4 \12\ thereunder. At any time within 60 days of the filing
of the proposed rule change, the Commission may summarily abrogate 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.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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-CBOE-2009-005 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-CBOE-2009-005. 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, 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 No. SR-CBOE-2009-005 and should be
submitted on or before March 4, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
Florence E. Harmon,
Deputy Secretary.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. E9-2773 Filed 2-10-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Notices]
[Pages 77481-77484]
[FR Doc No: 2013-30506]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0002]; [Internal Agency Docket No. FEMA-B-1352]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before March 24, 2014.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1352, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.

    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.
    I. Non-watershed-based studies:

------------------------------------------------------------------------
                                             Community Map Repository
               Community                             Address
------------------------------------------------------------------------
           City of Virginia Beach, Virginia (Independent City)
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Virginia Beach.................  Department of Public Works,
                                          2405 Courthouse Drive,
                                          Municipal Center Building
                                          2, Virginia Beach, VA
                                          23456.
------------------------------------------------------------------------
           New Castle County, Delaware, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Delaware City..................  City Hall, 407 Clinton Street,
                                          Delaware City, DE 19706.
City of New Castle.....................  Public Works Building, 900
                                          Wilmington Road, New Castle,
                                          DE 19720-3638.
City of Wilmington.....................  Department of Licensing and
                                          Inspection, 800 North French
                                          Street, Wilmington, DE 19801.
Town of Middletown.....................  Town Hall, 19 West Green
                                          Street, Middleton, DE 19709.
Town of Odessa.........................  Town Hall, 315 Main Street,
                                          Odessa, DE 19730.
Town of Townsend.......................  Town Hall, 661 South Street,
                                          Townsend, DE 19734.
Unincorporated Areas of New Castle       New Castle County Land Use
 County.                                  Department, 87 Reads Way, New
                                          Castle, DE 19720.
------------------------------------------------------------------------
             Sussex County, Delaware, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Lewes..........................  City Hall, 114 East 3rd Street,
                                          Lewes, DE 19958.
City of Milford........................  Planning Department, 201 South
                                          Walnut Street, Milford, DE
                                          19963.
City of Rehoboth Beach.................  Building and Licensing
                                          Department, 306 Rehoboth
                                          Avenue, Rehoboth Beach, DE
                                          19971.
City of Seaford........................  City Hall, 414 High Street,
                                          Seaford, DE 19973.
Town of Bethany Beach..................  Building Inspector's Office,
                                          214 Garfield Parkway, Bethany
                                          Beach, DE 19930.
Town of Bethel.........................  Secretary's Residence, 908 West
                                          Street, Bethel, DE 19931.
Town of Blades.........................  Town Hall, 20 West Fourth
                                          Street, Blades, DE 19973.
Town of Bridgeville....................  Town Hall, 101 North Main
                                          Street, Bridgeville, DE 19933.
Town of Dagsboro.......................  Town Hall, 33134 Main Street,
                                          Dagsboro, DE 19939.
Town of Dewey Beach....................  Town Hall, 105 Rodney Avenue,
                                          Dewey Beach, DE 19971.
Town of Fenwick Island.................  Building Department, 800
                                          Coastal Highway, Fenwick
                                          Island, DE 19944.
Town of Greenwood......................  Town Hall, 100 West Market
                                          Street, Greenwood, DE 19950.
Town of Henlopen Acres.................  Henlopen Acres Town Hall, 104
                                          Tidewater Road, Rehoboth
                                          Beach, DE 19971.
Town of Laurel.........................  Code Enforcement Office, 201
                                          Mechanic Street, Laurel, DE
                                          19956.
Town of Millsboro......................  Town Center, 322 Wilson
                                          Highway, Millsboro, DE 19966.
Town of Millville......................  Town Hall, 36404 Club House
                                          Road, Millville, DE 19967.
Town of Milton.........................  Town Hall, 115 Federal Street,
                                          Milton, DE 19968.
Town of Ocean View.....................  Wallace A. Melson Municipal
                                          Building, 201 Central Avenue,
                                          2nd Floor, Ocean View, DE
                                          19970.
Town of Slaughter Beach................  Town Office, 357 Bay Avenue,
                                          Slaughter Beach, DE 19963.
Town of South Bethany..................  Town Hall, 402 Evergreen Road,
                                          South Bethany, DE 19930.
Unincorporated Areas of Sussex County..  Sussex County Planning and
                                          Zoning Department, 2 The
                                          Circle, Georgetown, DE 19947.
------------------------------------------------------------------------
          Anne Arundel County, Maryland, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Annapolis......................  Department of Neighborhood and
                                          Enivornmental Programs, 145
                                          Gorman Street, Annapolis, MD
                                          21401.
Town of Highland Beach.................  Town Hall, 3243 Walnut Drive,
                                          Highland Beach, MD 21403.
Unincorporated Areas of Anne Arundel     Anne Arundel County Department
 County.                                  of Inspections and Permits,
                                          2664 Riva Road, Annapolis, MD
                                          21401.
------------------------------------------------------------------------
            Caroline County, Maryland, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Town of Denton.........................  Municipal Offices Building, 13
                                          North 3rd Street, Denton, MD
                                          21629.
Town of Federalsburg...................  Town Hall, 118 North Main
                                          Street, Federalsburg, MD
                                          21632.

Town of Goldsboro......................  Town Hall, 505 Old Town Road,
                                          Goldsboro, MD 21636.
Town of Greensboro.....................  Town Hall, 111 South Main
                                          Street, Greensboro, MD 21639.
Town of Henderson......................  Town Hall, 318 Henderson Road,
                                          Henderson, MD 21640.
Town of Hillsboro......................  Town of Hillsboro, 22043 Church
                                          Street, Hillsboro, MD 21641.
Town of Preston........................  Town Hall, 105 Backlanding
                                          Road, Preston, MD 21655.
Unincorporated Areas of Caroline County  Caroline County Department of
                                          Planning and Codes, Health &
                                          Public Services Building, 403
                                          South 7th Street, Suite 210,
                                          Denton, MD 21629.
------------------------------------------------------------------------
            Charles County, Maryland, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Town of Indian Head....................  Town Hall, 4195 Indian Head
                                          Highway, Indian Head, MD
                                          20640.
Unincorporated Areas of Charles County.  Charles County Department of
                                          Planning and Growth
                                          Management, 200 Baltimore
                                          Street, La Plata, MD 20646.
------------------------------------------------------------------------
            Somerset County, Maryland, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
City of Crisfield......................  City Hall, 319 West Main
                                          Street, Crisfield, MD 21817.
Town of Princess Anne..................  Town Hall, 30489 Broad Street,
                                          Princess Anne, MD 21853.
Unincorporated Areas of Somerset County  Somerset County Department of
                                          Technical and Community
                                          Services, 11916 Somerset
                                          Avenue, Suite 211, Princess
                                          Anne, MD 21853.
------------------------------------------------------------------------
             Centre County, Pennsylvania (All Jurisdictions)
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Township of Benner.....................  Benner Township Office, 1224
                                          Buffalo Run Road, Bellefonte,
                                          PA 16823.
------------------------------------------------------------------------
             Essex County, Virginia, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Town of Tappahannock...................  Town Office, 915 Church Lane,
                                          Tappahannock, VA 22560.
Unincorporated Areas of Essex County...  Essex County Building and
                                          Zoning Department, 202 South
                                          Church Lane, Tappahannock, VA
                                          22560.
------------------------------------------------------------------------
           Northumberland County, Virginia (All Jurisdictions)
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Northumberland County (All               Northumberland County Building
 Jurisdictions).                          and Zoning Department, 72
                                          Monument Place, Heathsville,
                                          VA 22473.
------------------------------------------------------------------------
            Richmond County, Virginia, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Unincorporated Areas of Richmond County  Richmond County Administrator's
                                          Office, 101 Court Circle,
                                          Warsaw, VA 22572.
------------------------------------------------------------------------
             Surry County, Virginia, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Town of Claremont......................  Municipal Building, 4115 Spring
                                          Grove Road, Claremont, VA
                                          23899.
Unincorporated Areas of Surry County...  Surry County Government Center,
                                          45 School Street, Surry, VA
                                          23883.
------------------------------------------------------------------------
          Westmoreland County, Virginia, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Town of Colonial Beach.................  Building and Zoning Office, 905
                                          McKinney Boulevard, Colonial
                                          Beach, VA 22443.
Unincorporated Areas of Westmoreland     Westmoreland County Land Use
 County.                                  Administration, 111 Polk
                                          Street, Montross, VA 22520.
------------------------------------------------------------------------
              York County, Virginia, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------

Unincorporated Areas of York County....  York County Computer Support
                                          Services, 120 Alexander
                                          Hamilton Boulevard, Yorktown,
                                          VA 23690.
------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: November 20, 2013.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2013-30506 Filed 12-20-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Rules and Regulations]
[Page 47004]
[FR Doc No: 2014-19064]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2014-0656]

Safety Zone; Pyro Spectaculars for USS MIDWAY Museum, San Diego,
CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Pyro Spectaculars USS MIDWAY
Museum firework display safety zone on August 28, 2014. This marine
event occurs on the navigable waters of San Diego Bay, immediately to
the west of the USS MIDWAY, in San Diego, California. This action is
necessary to provide for the safety of the participants, crew,
spectators, safety vessels, and general users of the waterway. During
the enforcement period, persons and vessels are prohibited from
entering into, transiting through, or anchoring within this regulated
area unless authorized by the Captain of the Port, or his designated
representative.

DATES: The regulations for the marine event listed in the Table to 33
CFR 165.1123(6) will be enforced on August 28, 2014 from 9 p.m. to 9:30
p.m.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Petty Officer Giacomo Terrizzi, Waterways Management,
U.S. Coast Guard Sector San Diego, CA; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in San Diego Bay for the Pyro Spectacular, Inc for USS MIDWAY Museum
fireworks display in 33 CFR 165.1123, Table 1, Item 6 from 9:00 p.m. to
9:30 p.m.
    Under the provisions of 33 CFR 165.1123, persons and vessels are
prohibited from entering into, transiting through, or anchoring within
the 600 foot regulated area safety zone that includes the tug and barge
unless authorized by the Captain of the Port, or his designated
representative. Persons or vessels desiring to enter into or pass
through the safety zone may request permission from the Captain of the
Port or a designated representative. If permission is granted, all
persons and vessels shall comply with the instructions of the Captain
of the Port or designated representative. Spectator vessels may safely
transit outside the regulated area, but may not anchor, block, loiter,
or impede the transit of participants or official patrol vessels or
commercial traffic within the federal channel. The Coast Guard may be
assisted by other Federal, State, or local law enforcement agencies in
patrol and notification of this regulation.
    This notice is issued under authority of 5 U.S.C. 552 (a) and 33
CFR 165.1123. In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with advance
notification of this enforcement period via the Local Notice to
Mariners, Broadcast Notice to Mariners, and local advertising by the
event sponsor. If the Captain of the Port Sector San Diego or his
designated representative determines that the regulated area need not
be enforced for the full duration stated on this notice, he or she may
use a Broadcast Notice to Mariners or other communications coordinated
with the event sponsor to grant general permission to enter the
regulated area.

    Dated: July 25, 2014.
S.M. Mahoney,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2014-19064 Filed 8-11-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 73 (Wednesday, April 16, 2014)]
[Notices]
[Pages 21471-21473]
[FR Doc No: 2014-08589]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0386]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Orphan Drugs Products: Common European Medicines
Agency/Food and Drug Administration Application Form for Orphan
Medicinal Product Designation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on Orphan Drug Products: Common
EMEA/FDA Application Form for Orphan Medicinal Product Designation
(Form FDA 3671).

DATES: Submit written or electronic comments on the collection of
information by June 16, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Orphan Drugs--21 CFR Part 316 (OMB Control Number 0910-0167)--Extension

    FDA is amending the 1992 Orphan Drug Regulations, part 316 (21 CFR
part 316). The 1992 regulations were issued to implement sections 525
through 528 of the Orphan Drug Act Amendments to the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360aa through 360ee) (the FD&C Act).
The 1992 regulations specify the procedures for sponsors of orphan
drugs to use in obtaining the incentives provided for in the FD&C Act
and set forth the procedures that FDA will use in administering the
FD&C Act.
    The amendments are intended to clarify regulatory provisions and
make minor improvements to address issues that have arisen since the
issuance of the regulations in 1992. They are intended to assist
sponsors who are seeking and who have obtained orphan drug
designations, as well as FDA in its administration of the orphan drug
program. Except with respect to the two revisions addressed further,
the revisions in this rule clarify existing language and do not
constitute a substantive or material modification to the approved
collections of information in current part 316 (see 5 CFR 1320.5(g)).
The collections of information in current part 316 have been approved
by OMB in accordance with the PRA under OMB control number 0910-0167.

    One revision concerns the name of the drug in an orphan-drug
designation request. As provided in current Sec.  316.20(b)(2) (Content
and format of a request for orphan-drug designation), requests for
orphan-drug designation must include the generic and trade name, if
any, of the drug. For some products, however, neither a generic or
trader name may be available. This can be the case for some large and
complicated biological products or for any molecule for which the
sponsor has not yet obtained a trade name. Under Sec.  316.20(b)(2) as
revised, requests for designation must include a chemical name or a
meaningful descriptive name of the drug if neither a generic nor trade
name is available. Drug names need to be meaningful to the public
because the Orphan Drug Act (Pub. L. 97-414) requires that notice
respecting designation of a drug be made available to the public
(section 526(c) of the FD&C Act and Sec.  316.28 (Publication of orphan
drug designations)). Internal business codes or other similar
identifies do not suffice for publication purposes as they do not
provide meaningful notice to the public of a designation. By providing
a chemical name or a meaningful descriptive name of a drug in a request
for designation, if neither a generic nor trade name is available,
sponsors would help ensure that the name of the product that FDA
ultimately publishes upon designation is accurate and meaningful.
    FDA regulations are currently silent on when sponsors must respond
to a deficiency letter from FDA on an orphan-drug designation request.
FDA sends such deficiency letters when a request lacks necessary
information or contains inaccurate information, i.e., miscalculated
prevalence estimate. This rule revises Sec.  316.24(a) (Deficiency
letters and granting orphan-drug designation) to include a requirement
that sponsors respond to deficiency letters from FDA on designation
requests within 1 year of issuance of the deficiency letter, unless
within that time frame, the sponsor requests an extension of time to
respond. FDA will grant all reasonable requests for an extension. In
the event the sponsor fails to respond to the deficiency or request an
extension of time to respond within the 1 year time frame, FDA may
consider the designation request voluntarily withdrawn. This proposal
is necessary to ensure that designation requests do not become
``stale'' by the time they are granted, such that the basis for the
initial request may no longer hold.
    Sections 525 through 528 of the FD&C Act gives FDA statutory
authority to do the following: (1) Provide recommendations on
investigations required for approval of marketing applications for
orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set
forth conditions under which a sponsor of an approved orphan drug
obtains exclusive approval, and (4) encourage sponsors to make orphan
drugs available for treatment on an ``open protocol'' basis before the
drug has been approved for general marketing. The implementing
regulations for these statutory requirements have been codified under
part 316 and specify procedures that sponsors of orphan drugs use in
availing themselves of the incentives provided for orphan drugs in the
FD&C Act and sets forth procedures FDA will use in administering the
FD&C Act with regard to orphan drugs. Section 316.10 specifies the
content and format of a request for written recommendations concerning
the non-clinical laboratory studies and clinical investigations
necessary for approval of marketing applications. Section 316.12
provides that, before providing such recommendations, FDA may require
results of studies to be submitted for review. Section 316.14 contains
provisions permitting FDA to refuse to provide written recommendations
under certain circumstances. Within 90 days of any refusal, a sponsor
may submit additional information specified by FDA. Section 316.20
specifies the content and format of an orphan drug application which
includes requirements that an applicant document that the disease is
rare (affects fewer than 200,000 persons in the United States annually)
or that the sponsor of the drug has no reasonable expectation of
recovering costs of research and development of the drug. Section
316.26 allows an applicant to amend the applications under certain
circumstances. Section 316.30 requires submission of annual reports,
including progress reports on studies, a description of the
investigational plan, and a discussion of changes that may affect
orphan status. The information requested will provide the basis for an
FDA determination that the drug is for a rare disease or condition and
satisfies the requirements for obtaining orphan drug status. Secondly,
the information will describe the medical and regulatory history of the
drug. The respondents to this collection of information are
biotechnology firms, drug companies, and academic clinical researchers.
    The information requested from respondents, for the most part, an
accounting of information already in the possession of the applicant.
It is estimated, based on frequency of requests over the past 3 years,
that 275 persons or organizations per year will request orphan-drug
designation and none will request formal recommendations on design of
preclinical or clinical studies.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
316.10, 316.12, and 316.14......               2               1               2             100             200
316.20, 316.21, and 316.26......             225               2             450             150          67,500
FDA Form 3671...................              50               3             150              45           6,750
316.22..........................              65               1              65               2             130
316.27..........................              43               1              43               5             215
316.30..........................             450               1             450               3           1,350
316.36..........................               2               3               6              15              90
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          76,235
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08589 Filed 4-15-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 108 (Tuesday, June 8, 2021)]
[Notices]
[Pages 30514-30515]
[FR Doc No: 2021-11971]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-0611]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Voluntarily
Implement a Safety Management System (SMS)

AGENCY: Federal Aviation Administration (FAA), Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget's (OMB) approval to renew an information
collection. The information collection is for entities who voluntarily
follow the guidance in FAA Advisory Circular (AC) 120-119, Voluntary
Safety Management System for Other Regulated Entities Transporting
Dangerous Goods by Air, on how to use the SMS principles included in
part 5, as a basis to develop and implement a voluntary SMS program and
how to submit such a voluntary program to the FAA's Office of Hazardous
Materials Safety (AXH) for acceptance. Information received from the
first collection will be used to determine compliance with FAA SMS
regulations. With the exception of a one-time submission of an
implementation plan, the data will not be submitted to the FAA. The
records for Safety Policy, Safety Risk Management, and Safety Assurance
processes, training, and communications are kept under Safety Promotion
and will be kept by the organization and used in its SMS.

DATES: Written comments should be submitted by August 9, 2021.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Andrea Giordani, Security and
Hazardous Materials Safety, Office of Hazardous Materials Safety (AXH-
002), Federal Aviation Administration, 800 Independence Avenue SW,
Washington, DC 20591;<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: To be determined.
    Title: Voluntarily Implement a Safety Management System (SMS).
    Form Numbers: N/A.
    Type of Review: Clearance of a new information collection.
    Background: Advisory Circular (AC) No. 120-119 provides information
on how entities subject to the regulatory requirements of Title 49 of
the Code of Federal Regulations (CFR) parts 171-180 (e.g., entities
performing functions such as, but not limited to, handling or shipping
of dangerous goods by air and hereinafter referred to as ``other
regulated entities'') may choose to voluntarily implement a Safety
Management System (SMS) as described in Title 14 CFR, part 5--Safety
Management Systems.
    This AC addresses general SMS principles and explains certain
regulatory requirements outlined in 14 CFR part 5. While part 5 does
not apply to voluntary SMS programs, it describes the general SMS
framework and serves as a non-binding basis for the development and
implementation of voluntary SMS programs. This AC provides guidance to
organizations on how to use the SMS principles included in part 5, as a
basis to develop and implement a voluntary SMS program and how to
submit such a voluntary program to the FAA's Office of Hazardous
Materials Safety (AXH) for acceptance.

    The organization collects and analyzes safety data and maintains
training and communications records for its SMS. Data and records are
essential for an SMS. Any organization that volunteers for this process
is required to maintain records of SMS outputs, training records, and
communications materials used to promote safety. An organization may
create a gap analysis to identify what already exists within that
organization and what needs to be created to complete the SMS
implementation plan. The organization's implementation plan is
submitted once to FAA for approval. As needed, other information may be
requested or submitted as part of ongoing SMS evaluation.
    Respondents: The FAA estimates that a total of three companies will
voluntarily implement an SMS.
    Frequency: The FAA assumes that the implementation plan is a one-
time burden that takes place over three (3) years for organizations
that choose to comply.
    Estimated Average Burden per Response: 6,680 hours reporting and
170 hours recordkeeping.
    Estimated Total Annual Burden: 20,040 hours reporting and 6,120
hours recordkeeping.

    Issued in Washington, DC, on June 3, 2021.
Daniel Benjamin Supko,
Executive Director, FAA, Office of Hazardous Materials Safety.
[FR Doc. 2021-11971 Filed 6-7-21; 8:45 am]
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[Federal Register Volume 88, Number 179 (Monday, September 18, 2023)]
[Rules and Regulations]
[Pages 63836-63837]
[FR Doc No: 2023-19595]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-0583; Airspace Docket No. 22-ACE-20]
RIN 2120-AA66

Modification of Class E Airspace; Alliance Municipal Airport,
Alliance, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; delay of effective date; modification of order.

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SUMMARY: This action delays the original effective date and changes the
version of FAA Order JO 7400.11 amended in the final rule published on
August 16, 2023. This action also republishes the text of that final
rule modifying Class E airspace extending upward from 700 feet above
the surface to adequately contain all instrument flight rule (IFR)
procedures at Alliance Municipal Airport, NE. This action supports the
safety and management of IFR operations at the airport.

DATES: The final rule published at 88 FR 55553, August 16, 2023, is
delayed until 0901 UTC, November 30, 2023. This action is effective
date 0901 UTC, November 30, 2023. The Director of the Federal Register
approves this incorporation by reference action under 1 CFR part 51,
subject to the annual revision of FAA Order JO 7400.11 and publication
of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11H Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Keith T. Adams, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198, telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies Class E airspace to supports the safety and
management of IFR operations at Alliance Municipal Airport.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2023-0583 in the Federal Register (88 FR 22385, April 13, 2023),
proposing to modify Class E airspace at Alliance Municipal Airport,
Alliance, NE. Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. No comments were received. The FAA published a final rule for this
docket in the Federal Register (88 FR 55553) on August 16, 2023, with
an effective date of October 5, 2023. For administrative reasons, the
FAA republishes this final rule with a delayed effective date of
November 30, 2023, and an amendment to the currently effective version
of FAA Order JO 7400.11.

Incorporation by Reference

    Class E5 airspace area is published in paragraph 6005 of FAA Order
JO 7400.11, Airspace Designations and Reporting Points, which is
incorporated by reference in 14 CFR 71.1 on an annual basis. This
document amends the current version of that order, FAA Order JO
7400.11H, dated August 11, 2023 and effective September 15, 2023. FAA
Order JO 7400.11H is publicly available as listed in the ADDRESSES
section of this document. These amendments will be published in the
next update to FAA Order JO 7400.11.
    FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by modifying Class E airspace
beginning at 700 feet above the surface at Alliance Municipal Airport,
NE. Class E airspace beginning at 700 feet above the surface is
expanded to a 7.6-mile radius to fully contain arriving IFR aircraft
operating below 1,500 feet above the surface.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (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);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p.389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11H, Airspace Designations and Reporting Points, dated August 11,
2023, and effective September 15, 2023, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above.

* * * * *

ACE NE E5 Alliance, NE [Amended]

Alliance Municipal Airport, NE
    (Lat. 42[deg]03'12'' N, long. 102[deg]48'14'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.6-mile radius of the airport.
* * * * *

    Issued in Des Moines, Washington, on September 6, 2023.
B.G. Chew,
Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2023-19595 Filed 9-15-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 16, 2009 (Volume 74, Number 240)]
[Rules and Regulations]
[Page 66570-66571]
[DOCID:fr16de09-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0197; Airspace Docket No. 09-AAL-4]

Establishment of Class E Airspace; Clarks Point, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at Clarks Point, AK,
to accommodate new Area Navigation (RNAV) Standard Instrument Approach
Procedures (SIAPs) at Clarks Point Airport. The FAA is taking this
action to enhance safety and management of Instrument Flight Rules
(IFR) operations at Clarks Point Airport.

DATES: Effective 0901 UTC, February 11, 2010. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, AAL-538G, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet address: http://www.faa.gov/about/
office_org/headquarters_offices/ato/service_units/systemops/fs/
alaskan/rulemaking/.

SUPPLEMENTARY INFORMATION:

History

    On Wednesday, October 7, 2009, the FAA published a notice of
proposed rulemaking in the Federal Register to establish Class E
airspace at Clarks Point, AK (74 FR 51524).
    Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments were received. The rule is adopted as proposed.
    The Class E airspace areas designated as 700/1,200 ft. transition
areas are published in paragraph 6005 of FAA Order 7400.9T, Airspace
Designations and Reporting Points, signed August 27, 2009, and
effective September 15, 2009, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by establishing Class E airspace at Clarks Point Airport, AK,
to accommodate new RNAV SIAPs at Clarks Point Airport. This Class E
airspace will provide adequate controlled airspace upward from 700 and
1,200 feet above the surface, for the safety and management of IFR
operations at Clarks Point Airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(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);
and (3) does not warrant preparation of a regulatory evaluation, as the
anticipated impact is so minimal. Because this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart 1, section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it creates Class E airspace sufficient in size to contain aircraft
executing instrument procedures for the Clarks Point Airport and
represents the FAA's continuing effort to safely and efficiently use
the navigable airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING
POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9T, Airspace Designations and Reporting
Points, signed August 27, 2009, and effective September 15, 2009, is
amended as follows:

Paragraph 6005 Class E Airspace Extending Upward From 700 Feet or
More Above the Surface of the Earth.

* * * * *

AAL AK E5 Clarks Point, AK [New]

Clarks Point Airport, AK
    (Lat. 58[deg]50'01'' N., long. 158[deg]31'46'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of the Clarks Point Airport, AK; and that
airspace extending upward from 1,200 feet above the surface within a
73-mile radius of the Clarks Point Airport, AK.
* * * * *

    Issued in Anchorage, AK, on December 3, 2009.
Michael A. Tarr,
Acting Manager, Alaska Flight Services Information Area Group.
[FR Doc. E9-29848 Filed 12-15-09; 8:45 am]

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